Gnanakani et al., IJPSR, 2023; Vol. 14(11): 5181-5196.

E-ISSN: 0975-8232; P-ISSN: 2320-5148

IJPSR (2023), Volume 14, Issue 11 (Review Article)

Received on 15 February 2023; received in revised form, 17 May 2023; accepted, 31 May 2023; published 01 November 2023

A COMPREHENSIVE REVIEW ON REGULATORY REQUIREMENTS OF PHARMA-

CEUTICAL DRUG PRODUCTS IN CIS AND GCC COUNTRIES
S. Princely Ebenezer Gnanakani * 1, P. Kala Sree 2 and K. P. S. Praneetha 2
Department of Pharmaceutical Biotechnology 1, Department of Regulatory Affairs 2, Vikas Institute of
Pharmaceutical Sciences, Rajahmundry - 533102, Andhra Pradesh, India.
Keywords: ABSTRACT: India may have a potential in the Commonwealth of Independent
CIS, Russia, Ukraine, Armenia,
States (CIS) region. Pharmaceuticals are difficult to register with the CIS
Uzbekistan, GCC region's regulating organisation because of the turmoil among these countries.
Correspondence to Author: The CIS includes Russia, Ukraine, Kyrgyzstan, Uzbekistan, Tajikistan,
Kazakhstan, Turkmenistan, Azerbaijan, Armenia, Belarus, Moldova, and
Dr. S. Princely E. Gnanakani, M
Georgia. These call for various regulatory standards for drug registration. Based
Pharm, PhD.
on the FDA's recommendations, it will be problematic to have various policies in
Professor, the same area- activity of exporters and producers; registration of the same
Department of Pharmaceutical product in various nations; work of manufacturers and exporters. The same
Biotechnology, Vikas Institute of documents cannot be used to implement CIS due to the lack of regulatory
Pharmaceutical Sciences, harmonisation. Manufacturers and exporters must submit various country-
Rajahmundry - 533102, Andhra specific documents to reach these markets since these nations adhere to a
Pradesh, India. country-specific document format. Both Ukraine and Kazakhstan have enacted
stringent regulations and are awaiting United States Food and Drug
E-mail: [email protected]
Administration (USFDA) - level document certification. The Gulf Cooperation
Council (GCC) is regarded as a "growing industry both in terms of trade
agreements and drug exportation." During 2008–2009 in certain cases, the
GCC's healthcare sector will indeed be dominated by patented medications. This
article’s purpose is to assess existing regulatory frameworks of the GCC member
countries (Bahrain, Oman, Kuwait, Saudi Arabia, Qatar, and the United Arab
Emirates (UAE) to ascertain a coordinated approach. In addition to the GCC
Team, the GCC Commission for Drug Monitoring was founded and put into
action by purchasing medications as well as pharmaceuticals on its own efforts.
INTRODUCTION: The field of regulatory affairs It is formed in response to the government's desire
(RA) serves as a link between the global to safeguard controlling the effectiveness and
pharmaceutical sector and regulators. One of the safety of pharmaceuticals, veterinary medications,
responsibilities of these authorities or bodies is to and medical supplies, pesticides, agricultural
stay up to date with changes in the regulations chemicals, cosmetics, and other products.
governing pharmaceutical drug research,
1
distribution, and marketing . Companies that are in charge of these items'
research, manufacture, testing, and sale furthermore
QUICK RESPONSE CODE wish to guarantee the effectiveness and safety of
DOI:
10.13040/IJPSR.0975-8232.14(11).5181-96 their products for the overall welfare of the public
2
. Interpretation, application, and communication
within and outside of the organisations are crucial
This article can be accessed online on
www.ijpsr.com to the effectiveness of the regulatory process. Drug
Regulatory affairs is a brand-new career that was
DOI link: https://doi.org/10.13040/IJPSR.0975-8232.14(11).5181-96 developed by governments to safeguard global

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health by policing the efficacy and safety of declaration that was adopted. There are currently
products across a range of categories including 13 countries that make up the CIS. The Single
prescription drugs, veterinary drug treatments, Financial Space was established by the CIS leaders
medical devices, insecticides, agrochemicals, based on the free movement of people, capital,
cosmetics, and complementary and alternative labour, products, and activities (1993). The
medicines. The businesses that produce and market procedure of the control of enterprise wide being
these goods should make sure to offer high-quality incorporated into a business agreement was
goods to the general people for their health and accepted. The agreement provides advantageous
welfare. Nowadays, most agencies have skilled guidelines for the development of direct
regulatory affairs divisions. The only internal manufacturing relationships. In order to establish
department that experiences the least influence the necessary coordinating organisations (Belarus
from acquisitions, mergers, and economic and Russia) and promote future integration, the
downturns is the regulatory affairs department, Union of the Sovereign Republic was launched in
which is always innovating and growing 3. 1995.

History Overview of Pharmaceutical Industries Four countries signed the accord (Russia,
and Regulatory Affairs: In the 1950s, numerous Kyrgyzstan, Kazakhstan, and Belarus). Tajikistan
catastrophes, including those involving the formally joined the CIS states in 1999, following
sulfanilamide elixir, vaccines, and thalidomide, led the formation of the Council of Four nations. The
to a substantial increase of the rules that control the heads of five countries – Tajikistan, Russia,
efficacy, safety, and quality of pharmaceutical Kyrgyzstan, Kazakhstan, and Belarus – sanctioned
products. Additionally, this has resulted in stricter the agreement on the foundation of the Eurasian
guidelines for Marketing Authorization (MA) and Economic Community (2000). Armenia, Moldova,
Good Manufacturing Practices (GMPs). In order to and Ukraine were all participants in the Eurasian
understand the chronological development of the Economic Union. Uzbekistan announced its
current time of the pharmaceutical sector and membership in the group in 2005. The four nations
regulatory framework, we will quickly review the (Belarus, Russia, Kazakhstan, and Ukraine) agreed
historical evolution of policies in the USA, Europe, to establish the Common Economic Space (CES) in
and India. Keep an eye on what happens in India, 2003, as stated in Table 1. The coordinating
Europe, and the USA 3. authorities of the various nations bring them
together to form the Commonwealth of
CIS Countries: In December 1991, CIS was Independent Nations (executive, legislative, and
founded. Federal participants proclaimed CIS industrial cooperation bodies) 4.
cooperation based on equal sovereign rights in the
TABLE 1: LIST OF REGULATORY BODIES & RESPONSIBILITIES FOR CIS COUNTRIES
S. no. Country Name Regulatory Bodies Responsibilities
1 Armenia Pharmaceutical and medical Medications and veterinary drugs evaluated by experts
advancements research institute and submitted for registration in RA
2 Azerbaijan Centre for Experimental Expertise The Ministry of Health (MOH) is in charge of
controlling drug marketing and advertising
3 Belarus MOH Issuing permits for import and export of registered
pharmaceutical medicinal products
4 Georgia Department for Drugs and Narcotics Enforces Georgia's rules and regulations to safeguard the
in Georgia population' healthcare, economy, and protection
5 Kazakhstan National Center for Medical Establishing national strategies for quality surveillance
Equipment, Devices, and Drug of health care and creating the legal framework for such
Expertise oversight
6 Kyrgyzstan Ministry of Medical Devices and Supplies Kyrgyzstan's inhabitants with high-quality,
Drug Distribution secure, and safe medications
7 Moldova Medicines and Medical Devices Provides marketing approval for pharmaceuticals
Agency of the Republic of Moldova
8 Russia Federal Health care Surveillance Performs legal rules of medication prices that belong to
Service the government-approved list of essential medications

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9 Tajikistan MOH In Tajikistan, the Ministry of Health oversees and

controls the healthcare system
10 Turkmenistan MOH of Turkmenistan's Republic The MOH is in charge of registering pharmaceuticals
11 Ukraine MOH certification and pharmaceutical quality management
control
12 Uzbekistan The Republic of Uzbekistan's The MOH establishes the rules and regulations for
Ministry of Public Health pharmaceuticals and medical equipment

The Scientific Center of Drug and Medical State registration facilities for pharmaceuticals are
Technology Expertise's role in Armenia is to carry maintained by The Ministry of Health and the
out the country's drug policy and to guarantee the Medical Technology of Turkmenistan. The
security, effectiveness, and calibre of the country's professional organization is accountable for
pharmaceuticals. Legal measures are in place in registering drugs.
Azerbaijan to control the promotion and advertising
of prescription pharmaceuticals. The MOH is in The company has finished its examination of the
charge of changing how medications are advertised pharmaceutical product paperwork. In Ukraine, a
and promoted. specialist body called the State Expertise Centre
was in charge of preclinical and post-clinical
Granting permissions to import and export studies, drug products licensing and quality
recognized pharmaceutical and medical goods is standards, monitoring drug-related adverse
one of MOH's primary responsibilities in Belarus, outcomes, and approving the import and
along with inspecting products for state registration application of unregulated pharmaceutical drugs.
or reregistration. The National Regulatory The MOH develops the rules and regulations for
Authority in Georgia enforces Georgian rules and pharmaceuticals and medical equipment in
regulations to safeguard the public welfare, Uzbekistan. It handles state registration, medical
healthcare, and protection in the certification and device quality control, and pharmaceutical activity
distribution of manufactured or combined licensing 5-7.
medications, and only to licensed individuals.
CTD (Common Technical Document)
The MOH is accountable for emerging new DOSSIER: The human medical product method
regulatory frameworks on quality management and for obtaining marketing approval must include a
the legal structure for quality assurance of hospital CTD. The MOH, FDA, or equivalent entity must
services in Kazakhstan, in addition to abiding to the receive the regional format or CTD dossier together
rules for granting medical practice authorization. with additional necessary technical documentation
Establishing a control and oversight system to and regulatory manufacture approvals or another
afford the general population with a variety of appropriate authority.
secure, high-quality, and efficient drugs, medical
devices, pharmaceuticals, and beauty products is Pharmaceutical experts can give assistance for
the main objective of the regulating agency in drafting comprehensive technical documents for
Kyrgyzstan. product registration in various nations throughout
the world as given in Table 2 8. There are 5
The national medical regulatory body in Moldova modules in the CTD Dossier Compilation Format.
is responsible for the market authorization, market Module 1: Administrative and Prescribing
oversight, quality assurance during production, and information.
clinical trial oversight of pharmaceutical products.
Module 2: CTD Overview and Summary of
The Russian government abides by the regulatory pharmaceuticals.
oversight of the prices of medications recognized
on the government-approved list of innovative Module 3: Quality Overview (Pharmaceutical
pharmaceutical goods. The Republic of Tajikistan's documentation).
Ministry of Health oversees and supports the Module 4: Non-Clinical Research Reports.
country's public health system in addition to
Module 5: Clinical Research Reports.
controlling the health sector.

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TABLE 2: STRUCTURE OF CTD

ICH-CTD Overview Observations
Module 1: It contains records particular to each nation. Administrative Required for both generic and
Administrative and documentation, such as submitting registration forms and novel medications
prescribing information permitted reports, good manufacturing practises certification,
etc., make up the majority of it
Module 2: CTD It provides an overview of the data contained in the dossier's Need for generics and new
Overview and Modules 3 (Quality Data), 4 (Nonclinical Statistics), and 5 medications. Only a description of
summary of (Clinical Statistics). The analyst receives an overview of all a Factor responsible is necessary
pharmaceuticals submissions made across the implemented system in this for identical items
module
Module 3: Quality The standard for scientific information, pharmaceutical Entailed for both generic and novel
Overview industries information, and genetic analysis of both various medications
drugs and finished products are all covered in this module
Module 4: Non- Information on the pharmacological, physiological, and Not for similar medicinal products
Clinical Research chemical analysis of the pharmaceuticals are given in this
Reports module
Module 5: Clinical A careful assessment of patient research and pertinent A pharmacokinetic and
Research Reports studies is provided in this session pharmacodynamic study is the only
exception for similar medicines

In the semi-regulated and regulatory sectors, such  Organizations engaged.

as those found in the CIS, the USA, Australia, the  Description of the procedure including key
EU, Japan, etc., the CTD format dossier is timeframes.
frequently adopted 8-9.  Standards again for Centralized Process.

Gulf Cooperation Council (GCC) Countries: GCC Countries' Geographical Composition:

When it comes to pharmaceuticals exports and The six Gulf states' racial and ethnic composition
cross-border industry, the GCC region is regarded According to Table 3, the Gulf region, which is
as a "Entrepreneurial Firm." Considering the local made up of the 6 GCC member states (Bahrain,
legal standards can be useful when exporting Oman, Kuwait, Qatar, Saudi Arabia, and UAE), has
pharmaceuticals. A few events in the years 2008– a territory of 2,572,954 Km2 11. Its demographic
2009, such as the crisis or downturn inside the fully totals 47.5 million, with such an average lifespan of
advanced and governed markets of the EU and US, 29.1 years and an average lifespan of 75.4 years.
increased the desire for substitute company Saudi Arabia is the nation's most populous nation
locations. The importation of high-quality similar with the fastest growing economy. It was
medicines is encouraged by GCC rules, which may discovered that Qatar has the greatest average
be excellent news for Indian pharmaceutical lifespan and also the greatest infant mortality rate.
companies. The organization of Petroleum Bahrain, the tiniest of the nations, has the second-
Exporting Countries Council, also known as the highest average lifespan and the third-highest
Alliance again for Arab States of the Gulf, was Revenue among the nations with the least
established since May 25th, 1981. The Kingdom of populated and greatest Economy. The need for
Saudi Arabia, UAE, Sultanate of Oman, State of pharmaceuticals in the area might well be impacted
Kuwait, State of Bahrain, and State of Qatar seem by the racial composition of the GCC states. While
to be the original members 10. The Board has the number of individuals between the ages of 25
significantly harmonised laws ever since founding. and 64 achieved a median of 56.8% in 2014, the
Its efforts led to the creation and functioning of the fraction of individuals over the age of 65 attained a
GCC Commission for Pharmaceuticals Monitoring mean of 2.1%. The GCC community is primarily
as well as the GCC Group Purchasing of made up of youngsters, as per Alpen Vision 2013.
medications and medical equipment, among other Although infant mortality rates are declining, the
things. Additionally, the certification of production average lifespan is gradually rising, 12 which is
facilities and the consolidated process united the predicted to cause the corresponding figure to rise.
nation's medication certification. The study's main Therefore, signifies that over the coming
concern is the. generations, the demographic of the Gulf nations

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would probably grow significantly as even more rises in life span over the previous 25 years.
individuals attain the age of 60. This should raise According to the Alpen Financial Survey 2013, the
medical costs while elderly adults often have population is predicted to increase at a compound
higher hospital services than youngsters. According annual growth rate (CAGR) of 6.1% from 2012 to
to the number of old individuals in the GCC region 2050 13.
who need hospital services is rising as a result of
TABLE 3: GCC COUNTRIES GEOGRAPHICAL COMPOSITION
Country Area/km2 Population/ Median Life % % GDP ($) GDP
million age expectancy Population Populati in billion per
(2014) (years) at birth age (25–64 on age capita
(years) years) over 65 ($)
Bahrain 760 1.3 31.6 75.2 58.9 2.6 23.0 18,334
Kuwait 17,818 3.3 28.9 74.7 54.5 2.1 176.6 56,514
Oman 309,500 3.3 24.9 73.3 45.9 3.2 71.8 23,731
Qatar 11,586 2.1 32.6 78.3 70.8 0.8 173.0 90,523
Saudi Arabia 2,149,690 28.3 26.4 74.1 48.6 3.1 576.8 20,777
UAE 83,600 9.2 30.3 76.7 62.1 1 360.2 40,363
Total 2,572,954 47.5 – – – – –
Mean – – 29.1 75.3 56.8 2.1 230.4 41,707

In addition, the GCC nations' rising  Economic development boards (EDB), joint
industrialization and per capita spending, combined ventures and economic liberalization by GCC
with the region's warm country, have encouraged countries - Opportunities for Indian investors 15.
unhealthy lives and the intake of imbalanced meals,
which has resulted in a significant prevalence of Requirements: The registration procedures for
illnesses like overweight, diabetes, and pharmaceutical drugs in various CIS nations,
cardiovascular events 14. Market forces for medical including Regulators were concerned about
products made domestically have been influenced Belarus, Kazakhstan, Armenia, Ukraine,
by the high levels of wealth of the regional Uzbekistan, and Kazakhstan (pharmaceutical
individuals as a whole. Consumers show a company involves in export to CIS countries).
significant preference for private labels, that are Specific recommendations, rules, guidelines, and
still in the growing market despite patent expiration governing bodies were used to compile the data.
and the accessibility of less expensive counterfeit Additionally, the available articles evaluate the
alternatives (Alpen capital 2013). results.

Opportunities in the GCC Market: CIS Countries with its Corresponding

Authorization Process and Regulatory
 GCC countries - 80% demand of Conditions (Russia, Ukraine, Uzbekistan,
pharmaceuticals through import. Armenia):
Russia: To plan and carry out the legislation, the
 More than one million annual increase of regulatory agency works directly with the health-
population - Great potential for healthcare related authorities in the CIS countries. Each CIS
sector. country has registering rules and requirements. The
global authorization of drug products usually
 Largest trading partner after US - 6.8 USD
requires 24 months to accomplish. The documents
billion business annually.
have been written in Russian and therefore were
 Indian export to GCC countries- 119.25 USD formatted in accordance to Russian laws. The
billion (2002-03). prescribed work of bioequivalence studies was
completed by research institutions with
 Less custom duty on pharmaceuticals- duty-free accreditation in Russia. Original and generic
(Saudi Arabia & UAE) and 4-5% by all the products go through the same registration process.
remaining GCC members.

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Generic items were exempt from several  The CTD formatted report.
registration requirements while original products
must adhere to all of them. For instance, clinical  System representing specimens, active
studies for a novel product were required in Russia. pharmaceutical tests including, if necessary for
Bioequivalence tests can be conducted outside of evaluation, High performance liquid
Russia for generic medications as well 16. chromatography (HPLC) chambers.

Registration-Required Documents:  Packing information 18.

Registration Form with Supporting The Reliability of Enrolment: The licensing was
Documentation: The manufactured product's
good for five years.
binomial nomenclature, registered trademark (in
Latin), and worldwide non-proprietary identifier, as Conditions for Sustainability: Investigations of
well as any additional information (INN). lengthy sustainability were needed because Russia
has been in temperature zone II were undertaken at
 A list of excipients as well as a list of the
temperatures of 25°C to 2°C and 60% to 5%
dosages and indications for each active
relative humidity, whereas studies of short-term
pharmaceutical component.
stability were conducted at temperatures of 40°C to
 Storage conditions, Shelf life, Drug 2°C and 75% to 5% RH 19.
information, Packaging.
Authorization Costs and Schedule: The
 A manufacturer-issued legal authority certification process takes 210 days, so each
(Authentic Notarization with Expunction) given product produced by an overseas manufacturer
to a business with permission to complete the must pay a cost of $12,000 during that time.
registration process 17.
Russian Drug Regulatory Procedure: The
Powers and Certified Documents Include: regulating agency in Russia was called as Federal
Agency for Monitoring in Health, has a section of
 Free Selling Certificate, certified document health control called Roszdravnadzor that registers
(FSC). pharmaceutical products. The item was shipped to
Russia after being registered with the Russian
 A drug product's licence. Ministry of Health. Russia has a unique regulatory
system that was incompatible with the way
 Good manufacturing certification.
pharmaceutical items were regulated in the US or
 A certified true copy of the country-specific EU.
license application for the supplier.
Three steps make up the registration procedure.
 Regulatory Documentation, often known as The applicant was required to gather all required
Normative Technical Document (NTD). paperwork for the file at the beginning of the
process. The Federal State Unitary (FSU) then
 These include documentation that list the receives these documents after they have been
requirements, specifications, or qualities for translated into Russian. In order for them to
particular actions or outcomes. evaluate quality, efficiency, and safety, the file was
delivered to the strategic and analytical at the
 A duplicate Certification of Analysis (COA) of Centre for Product Quality Management and Centre
the drug component and the feedstock, sealed for Preclinical and Medical Research in the second
and signed by the industrial chemist. phase. It was the hardest and toughest step of the
 A duplicate of the company's registered and entire process. The penultimate step entails
approved copyright document. finishing this assessment and delivering the file to
Rosadravnadzor so that a product registration
 Details about the product's licensing in the certificate can be issued.
nation of the maker and some other nations.

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The length of the registration process will vary clinical and clinical study data. Reference tests
depending on how well the regulatory expert was and free samples were also necessary 21.
organised and performing. Additionally, if
additional clinical studies, quality assurance Persistence of Registration: The registration was
measures, or requests for additional clinical good for five years.
evidence from regulatory agencies were made, the
Stability Prerequisite: Although Ukraine was in
licensing deadline would be postponed. But
climate zone II, research of long-term durability
typically, the production of a Registry Certificate
should be done at temperatures of (25°C, 2°C) and
took approximately 18 months, with Stage I taking
(60%) relative humidity (RH), while studies of
around two months, Stage II about twelve months,
short-term stability should be done at temperatures
and Stage III about four months 20.
of (40°C, 2°C) and (75%, RH).
Ukraine: All pharmaceutical medications in
Registration time: Generally, 210 days 22.
Ukraine were usable upon state registration. Data
upon that registrant, producer, including specifics Fees Needed: This was EUR 100 for drug dosage
regarding the pharmaceuticals were required for forms; each additional dose and packet of the
state registration of pharmaceutical items (Methods medical product costs EUR 10.
of medication dose, a summary of its constituent
parts and active substances, both quantitative and Ukraine Registration Process: The candidate
qualitative formulations, and preservation provides the State Drug Inspector with the
guidelines, etc). The MOH of Ukraine's state expert registration application and the required supporting
centre oversees pharmaceutical product registration documentation, which attests to the drug products'
and quality monitoring. efficacy and safety. The State Drug Inspector will
analyse the supplied documentation in no more
Certificates Needed: than 90 days. In order to review the appropriate
The Essential Records were Necessary: materials, evaluate the medications, and refer the
application appropriately, the examination will
 A notarized document of the Statistical Process
work with the State Drug Inspector expert
Control (SPC) and an authority to act from the
institutions.
company's country were also required.
From a listing of descriptions of specialized centres
 A duplicate of the company's drug
that the Drug Control Inspector has compiled and
manufacturing permit that confirms towards the
updated, the applicant chooses the institution. The
company's right to create prescription
report that was given either straight to the applicant
medications.
or to the Drug Control Inspector must include the
 The countries in which the product was results of the test (conducted by the institutional
licensed; Normalized Technological experts). The State Drug Inspector will permit
Documentation (NTDs). examining of the drug goods grounded on the
conclusions of the expert institutes. Notably, the
 A certification stating that the European schedule of such exams won't change the duration
Pharmacopoeia (Ph. Eur.) standard was of the time. during which the specialist examination
appropriate. will be administered. When deciding whether to
register or reject a drug product for state
 Further, reference tests and free samples were registration, the Ministry of Health bases its
needed, together with a documentation for decision on expert testing findings and the
certification in the CTD (Common Technical recommended body's approval. The applicant was
Documents) format. informed by the state's drug inspector in ten days.
According to the Ukrainian Ministry of Health's
 All pharmaceutical products, regardless of
regulations, pharmaceutical items must be listed in
whether they're label or common, should
the official documents of the State Drug Inspector.
include a complete documentation of pre-

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A drug's state application for registration items was products and the specified amount must be used
obtained by applicants. If any additional medical during testing 26.
product modification was required, this must be
submitted with the certificate. The registration Persistence of Registration: The registration was
certificate has a maximum 5-year shelf life. Only good for five years.
once the drug product has been reregistered
Stability Prerequisite: Due to Uzbekistan's
following the end of the trade time in Ukraine were
climate zone II designation, studies of hard
sales and uses of the drug product permitted 23.
durability were conducted under conditions of heat
Renewal of Registration: Every five years, a drug (25°C 2°C) and moisture (60% 5% RH), whereas
product's registration must be revised. A renewal studies of short-term stability should be done under
required a submission, re-registration fees, context circumstances of temperature (40°C 2°C) &
- based (competence), and responses to any moisture (75% 5% RH).
deficiencies until the goods was approved were
Period for Registration: For 6 to 8 months.
required documents for the renewal of registration.
Non-clinical sample studies were not essential at Fees Needed: Application costs were 175 euros.
the time of registration renewal.
Uzbekistan Application Process:
Modern rules and standards must be followed when
renewing registration. The renewal process will  The applicant must provide two documents to
involve revisions to the registration documentation. the director of pharmaceuticals and medical
Separate applications should be included for each product testing for the licensing of
new alteration and required rationale 24. pharmaceutical products in Uzbekistan.

Uzbekistan: The Uzbekistan health ministry was in  The candidate sends in supporting paperwork
charge of application for registration of prescription and tests of the medication they intend to
drugs, medical instruments, and machinery. A five- register.
year registration certificate was provided based on
the application for registration of pharmaceuticals,  Following the submission of the paperwork and
medical devices, and hospital instruments. evidence, an agreement was reached between
the submitting company and the government
Medications, surgical instruments, and instruments, office for competence and standardisation in
as well as medical inventions, may all medical pharmaceuticals.
settings up until the registration certificate's validity
expires, provided that they were manufactured  The Department submits materials to the
within the registration certificate's legal production numerous specialist bodies (Medicinal Council
window and before that date 25. board, Drug Enforcement Council board,
Biosynthetic pathway Council board, and
Registration-Required Documents: The professional Council of specialists).
application form must be accompanied by an
authority of notary, the manufacturer's business  After reviewing materials and performing any
licence, a judicial manuscript of the company's standard actions on documentation, the Director
licence of drug sales attesting to the company's of Product Testing for Pharmaceuticals and
authorization to generate prescription medicines, a Medical Products declares a drug substances
certified copy of GMPs, overall pharmaceuticals license.
details, a manuscript of the applicant's as well as  The readily Determine Certificate will be
the company's written statement of contract, and a provided by the public registry within ten days
Certificate of Certification of Compliance (COPP). of receiving confirmation from the board of
The registration of the dossier was completed in a members 27.
four-part regional structure and includes regulatory,
biochemical, medical, bio-pharmacological, and Armenia: The Ministry of the Armenian People's
medical evidence. Duplicate specimens of the drug Republic has implemented the licensing of drugs.

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The Regulatory National Authority receives the the exam results for review. The Armenian
registration solicitations. The documentation was regulatory body then issues the registration
offered in English, Russian, or Armenian. Only certificate. The producing nation's GMP certificate
after registration were drugs allowed for import, was granted during the registration process; an
practise, and use in Armenia. examination of the manufacturing facility was not
necessary 29-30.
Documents Required for Registration: Summary
of Product Characteristics (SmPC), a certificate for GCC Countries:
a true copy of the pharmaceutical product, also
known as a Certificate of Pharmaceutical Product Drug Registration:
(CPP), a drug registration manual, a design of the
 Centralized registration procedure.
therapeutic agent, and a registration number of the
label were all necessary documents for registration.  Decentralized registration procedure.
For renewed registration, pharmaceuticals,
packages, and Periodic Safety Update Reports Officials participating in the GCC's Centralized
(PSUR) were required 28. Procedure: Gulf Healthcare Council (GHC) The
formed Healthcare Directors Committee oversaw
Persistence of Registration: The registration was member nation collaboration prior to the creation
good for five years. of the full GCC organization.
Stability Prerequisite: In light of the fact that Medical resources, top-notch technology, and
Armenia was in climate zone II, research on long- medical applications with a track record of
term stability was done at temperatures of 25°C to reliability, security, and effectiveness must all be
2°C and humidity levels of 60 percent to 5 percent purchased by the GHC. Through to the centralised
relative humidity, while studies of short-term process, all commodities need receive approval 31.
stability should be conducted at temperatures of
40°C to 2°C and humidity levels of 75 percent to 5 The executive office of Gulf Central Committee for
percent. Drug Registration (GCC-DR) accepts enrolment
documents with verification that all licensing
Registration Costs and Times: For 180-day prerequisites have been met and then upon properly
registration period, registration fees range from 900 completing the forms:
(thousands Armenian dram) for the generic drug's
initial dosage form and dosage strength to 450  The attached herewith for pharmaceutical firms.
(thousands Armenian dram) for further
pharmaceutical forms and dosage strengths to 450  A information sheet for medicinal active
(thousands Armenian dram) for new signs compounds or preparations.
(thousands Armenian dram) 29. 1. Two Specimens must be sent to every nation
Registration process for Armenia: The steps with the licensing document, together including
involved in registering a drug product in Armenia 8 comprehensive documents for every specific
include submitting registration dossier applications, chemical, 17 tests, and 17 test results must be
drug product samples, the full collection of presented to the executive office 32.
charges, the early assessment (equipment 2. Each nation was required to carefully review
surveillance), the choices taken during the early the enrolment documents that have been sent to
assessment, and the receipt of charges for expert it before returning them together with a
labour. Reviewing certain records (purity, security, suggestion to the commission. Fig. 1 illustrates
and effectiveness inspection), hazard control, and the process.
evaluating the production system were further
processes. The issue of specialised expertise has 3. The business must offer laboratories for such
been resolved. The medicine product's safety and examination of standardized products,
quality have been approved by the laboratory procedures, etc.
examination. The Pharmacological Board receives

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4. The executive office sends chemicals substance 6. The register document was issued by the
sampling collections to term referring executive office 33.
laboratories for testing.
7. The businesses have the option to file
5. The last verification and documents were complaints with the executive office following
concluded on a country-by-country basis in 2 months after receiving notice that they have
compliance with its specified and authorized been registered by that of the GCC-DR.
regulations just after centralized approval of the
establishment of a corporation and/ or chemical
entity.

FIG. 1: ELEMENTS OF THE DOSSIER

Costs for Registering Drugs: major product licensing regulations will be

Business Register: extensively discussed in this research 35.

▪ SR. 5000, which represents the 50% cost for Saudi Arabia: The primary Saudi Arabian
looking through the industry's record. regulating organisation for drugs was the Saudi
Food and Drug Authority (SFDA). The SFDA
▪ SR. 5000, whereby, with official consent and supports uploading of pharmaceutical
authorization of its registrations, will constitute documentation (eCTD). Up until May 20, 2010, the
50% of the remaining amount. SFDA had authorized and over 6177 medications
of various strengths as well as compositions. The
Register of Products: following were the conditions and steps for
marketing authorization 36:
▪ SR. 3000, which really was 50% of such
registering charge in exchange for reviewing Approval of Drugs:
the industry's documentation. Online Registration Submission: A registration
number was provided to the registrant after the
▪ SR. 3000, that, following official authorization application has been received to allow for easier
and consent for its registrations, equal to the with SFDA easier.
probability 50% of remaining fee 34.
To submit the application, the candidate must
The Decentralized Enrollment Process: GCC key schedule a meeting with SFDA headquarters. One
country registering laws whereas the GCC nations to twelve weeks in ahead was allowed for
have a centralised and largely uniform procedure scheduling the earlier consultation. One week prior
for registering drugs, certain major nations, like to the medical meeting, the candidate may postpone
Saudi Arabia and the UAE, have unique guidelines. 37
. Three days prior to the meeting, an automated
Several nations had built legislative framework that notification will be issued. The SFDA's system was
were upheld. These four GCC nation's (Saudi to regulate timeframe was displayed in following:
Arabia, Bahrain, Kuwait and UAE) multi-source

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Timelines for Achieving Goals: must be "adware" and unlocked without a

Procedure and Goal Achievement Period login; Arabian or English as the region 40.
(Days):
Approvals: Verified by both the Saudi Arabian
 Generic pharmaceutical marketing consulate as well as the state health department of
authorisation (MA) applications - 165 days the nation of origin. Those credentials were
necessary:
 Proposal for a marketing approval (MA) for a
unique chemical element (NCE) – 290 days  The COPP/free trade license.
 Biopharmaceuticals marketing authorisation  Certificates of Analysis (CoA).
(MA) request – 290 day 38.
 A statement saying no pork.
Format: CTD format was used. suggested by
eCTD. Modules 2 through 5: in ICH CTD format.  Retail value.
Module 1: localized specifications 39.
Bahrain: Bahrain's medicinal registration
 Request form. requirements were largely identical to those in the
remaining GCC nations. The Department of Health
 The elements list. in Bahrain requests all sorts of content, although in
contrast to certain other GCC nations, Bahrain
 A request form. places more emphasis just on specifics of the
official page and various economic operations,
 Packaging includes a description of the
such as the corporation's most group in partnership
company's products (SmPC), a product 41
.
specifications booklet (PIL), including
labelling, all in the standards prescribed in the Background Knowledge:
WHO standard.
 Case features.
 Details on the professionals who participate in
clinical and nonclinical investigations.  How many production facilities the firm owns.
 Risk analysis for the ecosystem.  Description for every location.
 Regulatory affairs.  Business and Economical ties within all
websites.
 Pharmaceuticals certification (COPP).
 Production permit from the home nation, with
 Valuations.. dates (Certificate of Origin - COO).
 Answers to the SFDA's inquiries (in any).  Identity and phone numbers for the application.
Demonstration:  GMP document was issued by the home nation.
 Hard copies were packed in laminated sheets  Amount of jobs in each department and
(A4 size, 2 laminated sheets). A maximum of information about respective qualifications.
300 pages per folder.
 Visual layout and project's information for the
 DVD or CD-ROM as a word document. One company workflow.
physical edition, two digital files. (Only
modules 1, 2, and 3 for New Chemical Entities  A listing among all goods produced by the
(NCEs), biopharmaceuticals, and biologic drugs business, any suppliers and manufacturers, and
were available in paper form). Content any additional parties with marketing rights
shouldn't be accessible; it must be autostartable; (Marketing Authorization Holder - MAH).

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 Connection to MAHs.  Pricing certification that has been verified

either by nation of Activision's health
 Any earlier examination by the GCC or Arab departments.
health agencies.
Kuwait: Kuwait has laws governing the safety,
Officials in the Ministry of Health with details: potency, and quality of medicines as well as market
Any purchase, merger, acquisition, or other judicial regulation and intellectual property rights. Kuwait
or business activity involving the organization or has maintained a legislative structure in place for
its property must be reported to MOH officials 40 years and was a major player in the GCC. The
within ninety days of the activity 42. primary governing agency that implements the
governmental directive 302/80 for the registration
Merchandise Information:
of drug repurposing was the Kuwait Food and Drug
 Amount of items uploaded. Authority (KuFDA) 43.

 Sample size provided. "Kuwait was confronting an enormous legislative

issue representing its remarkable progress of the
 List of contents (section) for the documents you regulating systems with available budgets
uploaded. potentially affecting consumers' prompt availability
of medications," claims Dr. Reem Al-Essa,
Document's Information: Director of a Registration Department of the
 A WHO-certificate of pharmaceuticals (COPP) Kuwait Pharmaceutical and Food Control.
that has been authorised by any mission in the Due to Kuwait's sparse population and lack of the
GCC. necessary knowledge to create a strong foundation
 A list of the device's attributes (SmPC). of production techniques for prescription medicines
in the nation, the drug manufacturing ecosystem
 All safety data, such as a test procedure, a there was not particularly efficient. The Kuwait-
validating statement, etc., were kept in a Saudi Drug Industry Co., or Kuwait-Saudi
distinct document specifically for the testing Pharmaceutical Industries Company (KSPICO),
laboratory. was Kuwait's sole manufacturer. This business
manufactures pharmaceutical drugs.
 Comprehensive explanation of Application
Programming Interface (API) and diluents Comprehensive Data:

 A summary of the previously owned • Normative benchmark using CoA.

automobiles and containers.
• Refined product illustration.
 A production method.
• Pamphlet providing health care (English and
 Address and contact information of the Arabic).
Contract Research Organizations (CROs)
participating (if any). • Origin of inert components and API supplies.

 Describe the outside backpack and any gear • Details of the raw resources.
that was utilized. • With the aid of quality management, desired
 Material ratio (per unit mass or volume). quality requirements.

 Origin of the initial substance. • Information on stabilisation

 Suggested title. • Three long batches (two pilot and one

production).
 Arabic/English brand patient data booklet.

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• The very same 3 sets of enhanced trials were  Packing, labelling, and health records leaflets.
employed for lengthy research and lasted 6
months.  Aspect of preservation and storage stability.

• Results of a bioavailability research.  Content.

Approvals:  Components made with animals.

• WHO-COPP.  Details in a booklet.

• COA.  Pharmaceutical qualities.

• A license stating that an item was  Information on generic drug bioavailability.

Transmissible Spongiform Encephalopathy
Each one of the 7 Government Regulators in the
(TSE)-free.
GCC has the following Institutional Framework,
• Official cost breakdown. Roles, and Areas of Responsibility: Through
direct contact with important regional regulatory
• Concentration of alcohol certification. agencies, the frameworks of the various GCC
government regulators have been examined in
• Component diploma. Table 4.
• Overview of nations in which a goods has a The following were indeed the authorized initials
registration. of the GCC officials: Bahrain's Public Healthcare
Protection Agency, Kuwait's State food and drug
UAE:
Control, Oman's Department Of public of Drug
Administration of Justice Data:
Matters and Drug Regulation, Qatar's
 Merchandise wholesaler in the UAE. Pharmaceuticals and Drug Regulation Dept, Saudi
Arabia's State Food and Drug Agency, and the
 Place of production. UAE's Enrollment and Drug Command
Headquarters were just a few examples of
 Legal representative and bearer of product organisations that regulate drugs. Five
registration. organisations were completely supported by the
 A producer of API. individual nations and operate independently of the
Department of Health. Furthermore, Saudi Arabia
 Legal standing. was a separate, autonomous government that
mostly receives money from application fee. The
 Cost summary. six GCC agencies oversee the regulation of
pharmaceuticals intended for human consumption.
 Announcement (in line with UAE Ministry of Their primary areas of focus include approval to
Health's Drug Enforcement Agency's laws on
market, post-marketing monitoring, and quality
pharmaceuticals) 44
assurance evaluation. Regardless of the size and
Documentation: benefits required for every supervisory agency,
they also perform a number of other duties 45.
 Data on pharmaceutical drugs.
TABLE 4: GCC HAS THE FOLLOWING INSTITUTIONAL FRAMEWORK, ROLES, AND AREAS OF
RESPONSIBILITY
Country Bahrain Kuwait Oman Qatar Saudi Arabia UAE
Name of National Health Kuwait Drug The General The Saudi Food & The
authority Regulatory and Food Directorate of Pharmacy Drug Authority Registration
Authority Control Pharmacy and Drug and Drug and Drug
Control Control Control
Department Department

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Independent ✓ ✗ ✗ ✗ ✓ ✗
stand-alone
authority
Budget/GBP NA 2 million NA NA 85 million 1.6 million
Fees/GBP 9 230 130 None >5,000 NA
Scope of Medicines for ✓ ✓ ✓ ✓ ✓ ✓
registration human use
responsibilities Veterinary ✗ ✓ ✗ ✗ ✓ ✓
medicines
Medical ✓ ✓ ✓ ✓ ✓ ✓
devices and in
vitro
diagnostics
Cosmetic ✗ ✓ ✗ ✗ ✗ ✗
products
Food ✗ ✓ ✗ ✗ ✗ ✗
supplements
Herbal ✗ ✓ ✗ ✗ ✗ ✗
medicines
Scope of Marketing ✓ ✓ ✓ ✓ ✓ ✓
activities authorisation
Post-marketing ✓ ✓ ✓ ✓ ✓ ✓
surveillance
Sample analysis ✓ ✓ ✓ ✓ ✓ ✓
Advertising ✗ ✓ ✓ ✗ ✓ ✓
control
Price regulation ✓ ✓ ✗ ✓ ✓ ✓
GMP ✓ ✓ ✗ ✗ ✓ ✗
inspection
Clinical trial ✗ ✗ ✓ ✗ ✓ ✓
authorisation

CONCLUSION: There seems to be tremendous standards, and in certain cases circumstances, the
growth opportunity for India in the CIS. More than Member States, numerous Regional Harmonization
90% of India's total bilateral trade with the CIS was Initiatives (RHIs) have been developed. These
with Belarus, Kazakhstan, Kyrgyzstan, Russia, organizations were encouraged to suggest
Uzbekistan, and Ukraine, which were the key candidates to serve as permanent members of the
trading partners. To assess the diversity in Global Cooperative Group (GCG). Overall, Sales
document needs and registration procedures across of pharmaceutical formulations climbed between
different nations, research of both the legal Approximately USD 631.90 million in 2016-2017
provisions and procedure for a number of CIS to Approximately USD 788.27 million in 2018–
nations has indeed been carried out. The lack of 2019. Future pharma supplies to the CIS nations
coordination between these countries might result have enormous potential.
in unnecessary duplication of effort and waste of
precious resources, ultimately increasing ACKNOWLEDGMENTS: The authors thank the
medication lag. Harmonization makes it simpler Management of Vikas Institute of Pharmaceutical
and more efficient to enter multiple countries in a Sciences for providing support for data collection.
single goal. Companies can reduce the number of
CONFLICT OF INTEREST: Nil
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How to cite this article:
Gnanakani SPE, Sree PK and Praneetha KPS: A comprehensive review on regulatory requirements of pharmaceutical drug products in
CIS and GCC countries. Int J Pharm Sci & Res 2023; 14(11): 5181-96. doi: 10.13040/IJPSR.0975-8232.14(11).5181-96.
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