a brief analysis of regulatory structure and approval process of pharmaceuticals in gcc ·...

www.wjpps.com Vol 4, Issue 07, 2015.

1596

Chandra et al. World Journal of Pharmacy and Pharmaceutical Sciences

A BRIEF ANALYSIS OF REGULATORY STRUCTURE AND

APPROVAL PROCESS OF PHARMACEUTICALS IN GCC

Konuri Dinesh Chandra*, A. Elphine Prabahar, Nadendla Rama Rao

Department of Pharmaceutical Management and Regulatory Affairs, Chalapathi institute of

Pharmaceutical Sciences, Lam, Guntur - 522034, Andhra Pradesh, India.

ABSTRACT

Regulatory authorities in both developed and developing countries

share the responsibility of ensuring the access of safe and effective

medicines to patients; however their structures, strategies, and

practices vary significant. The gulf cooperation council region is

consider as “emerging market for pharmaceutical export and bilateral

trade some incidents of year 2008-09 generics will comprise a

significant part of the pharmaceutical sector in the GCC The aim of

this study was to evaluate the Gulf Cooperation Council (GCC)

regulatory systems (Bahrain, Kuwait, Oman, Qatar, Saudi Arabia,

United Arab Emirates (UAE)) in order to develop a harmonized

strategy. Seven GCC authorities to provide details of their review

process and the quality measures used to improve their assessment

procedures for applicability and practicality in the GCC region like

recession or economic slowdown in highly well off and regulated

market of EU and US raised the demand for alternate destinations for business. Smaller

pharma markets such as Qatar and Bahrain are likely to experience higher growth than the

comparatively developed market of Saudi Arabia. The GCC pharmaceutical sector has been

growing steadily along with the general uptrend within the region.

KEYWORDS: Gulf Cooperation Council, Pharmaceutical sector, Regulatory Requirements.

INTRODUCTION

GCC Pharmaceuticals Industry

GCC represents less than 1% of the global sector Pharmaceuticals market to double from

USD 5.5 billion within the next 9 years Growth of the sector is driven by, population growth,

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Article Received on

16 May 2015,

Revised on 07 June 2015,

Accepted on 29 June 2015

*Correspondence for

Author

Konuri Dinesh Chandra

Department of

Pharmaceutical

Management and

Regulatory Affairs

Chalapathi institute of

Pharmaceutical Sciences,

Lam, Guntur - 522034,

Andhra Pradesh, India.


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ageing population increased lifestyle diseases due to smoking and poor diet and requirement

to maintain health insurance Between 7-12% of GCC annual budgets are allocated for

healthcare spending 80% of drugs used in the region are imported. Represents USD 1 billion

75% patented products .The emerging GCC drug pharmacy market is undergoing a sea

change, with governments implementing reforms, simplifying regulations and upgrading and

expanding healthcare infrastructure to compete with the global pharmaceuticals market.

Domestic producers focus mainly on the manufacture of generic drugs but, given these

products’ high prices, end-users tend to lean towards branded drugs, the report notes, pointing

out that the World Health Organization (WHO) has estimated that drug products in the GCC

are priced 13 times higher than the international standard. There is no standardization in their

prices, due to the small size of the market and increasing privatization within the sector.

These strategies could include offering incentives to new local manufacturers to compete in

the growing market, while existing participants could be encouraged to introduce improved

technologies to survive in the multinational-dominated market.[1]

Fig: 1 Map of GCC Countries

Historical background

Ministerial Resolutions about GCC central drug registration

1976 The first conference “studies the possibility to establish system for registration and

monitoring pharmaceutical products”.

1977 The second conference they assigned committee to prepare the proposal.

1978 The resolution approved the proposal but as a guideline for each country.


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1981 The 10th conference they assigned a committee to study the registration system in

Kuwait, KSA, UAE.

1982 The 12th conference. Approved the proposal after a minor change.

1997 The unifying drug registration in GCC and requesting the executive office to study the

subject again.

1997 The Kingdom of Bahrain introduced the complete proposal.

1997 The resolution conspiring the importance and necessary of central drug registration.

1998 The Ministers’ Council for GCC called upon reviewing the proposal which was

introduced 1997.

1999 The Ministers’ Council approved the central drug registration system and its executive.

Saudi Arabia, Kuwait, UAE, Oman, Bahrain, Qatar

2. The Executive Board (EB).

3. The Executive office General Director

4. GCC_DR Secretariat 5. GCC_DR Steering

GCC States and Working Group

Fig: 2 Organizational Structure

Table 1: Drug Regulating Authorities of GCC

COUNTRY AUTHORITY

Kingdom of Bahrain Pharmacy and drug control department

State of Kuwait Pharmaceutical and herbal medicines registration

and control administration, Kuwait drug and food

State of Oman General directorate of pharmacy and drug control

State of Qatar Pharmacy and drug control department

Kingdom of Saudi Arabia Saudi food and drug authority

United Arab Emirates Registration and drug control department

1 .Council of Ministers of Health


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Scope of GCC Drug Regulatory Activities

Pre-Marketing Evaluation.

Marketing Authorization.

Post- Marketing Review.

GMP Inspection

Technical Guidelines

Documents Prepared and/or maintained by DRA department

Licenses and certificates obtained by Drug regulatory Authorities, Egg; Mfg. License, GMP,

COPP, ISO etc. Common Technical Document (CTD/eCTD) ASEAN Common Technical

Document (ACTD) Drug Master File, Clinical Trial Reports, Bioavailability &

Bioequivalence reports Quality Audit files and reports.[2]

GCC Countries Import (90 %) of Pharmaceutical Needs

The pharmaceutical market in GCC countries exceeds 6 billion USD. This market is growing

rapidly and is expected to reach around 10 billion USD by 2020. Despite the growth of this

market, local manufacturing is not able to meet the growing demand, and GCC countries

continue to import most (90 %) of their needs in medicines from abroad Therefore,

significant opportunities exist for growth and expansion of this sector in GCC Expanding

growth in this industry would also help to achieve the strategic objectives of the region in

terms of industrial diversification into knowledge based industries. As a part of its mandate to

promote technical and policy coordination. The proposed coordination meeting is the first of

its kind in the sector and it could serve as a catalyst to promote further coordination at the

horizontal and vertical levels The aforesaid meeting , the first ever of its kind in that sector, is

aimed at achieving several objectives including to create a forum for the exchange of ideas

and dialogue among pharmaceutical companies in GCC, propose a multi-client study that will

address the needs of the pharmaceutical industry in the region, and identify the need for

establishing a pharmaceutical trade association for GCC producers.[3]

REGISTRATION PROCEDURE

Gulf co operation council regulatory authorities Approved in May 1999 Located in the

executive officer for health ministers, Riyadh, Saudi Arabia.

Drug registration: two processes of drug registration

A. Centralized Procedure


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B. Decentralized Procedure

A. Centralized Registration Procedure

The executive office of GCC-DR assumes the receipt of registration files after ensuring the

fulfillment of registration requirements and upon duly filling the following forms: The drug

companies’ registration form .A pharmaceutical chemical entity preparation registration

form. Eight complete files for each chemical entity & 17 samples have to be submitted to the

executive office and two samples shall be dispatched to each country along with registration

file.[4]

B. Decentralized Registration Procedure

Registration regulations in major countries of GCC although there is a centralized and quite

harmonized process for drug registration in GCC countries, the regulatory requirements of

few big countries like Saudi Arabia and UAE are separate .these countries have their well

established regulatory system and its enforcement In this study we will discuss briefly the

registration requirements of multi source generic products of GCC countries Saudi Arabia,

Bahrain, Kuwait, Oman, UAE[5]

REGULATORY PROCESS OF KUWAIT

The most important goal of the Kuwaiti review process is to ensure that (a) the product is

registered and marketed in countries with recognized and competent regulatory authorities for

at least twelve months, (b) that the product meets the desired, internationally recognized,

quality standards to ensure that the product was manufactured for its intended use, (c) that the

product is stable for the entire proposed shelf life and for six months under the stressed

conditions of 40°C/75% relative humidity, and (d) the product price must be reasonable and

affordable for local patients.

The Submission Phase

The review process starts with the local agent (or the sponsor) submitting the registration

dossier along with a covering letter to the Director of Kuwait Drug and Food Control

(KDFC) officially requesting the registration of the pharmaceutical product..

The Evaluation Phase

After entering the scientific review stage, the reviewer evaluates the Chemical and

Manufacturing Control (CMC) data focusing on the following data,


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1. Product specifications and detailed methods of analysis of the finished products with the

reference pharmacopoeias.

2. Full stability studies in tabulated form addressing the proposed product shelf life.

3. Raw material specifications and their methods of analysis as well as the reference

pharmacopoeia.

The Authorization Phase

When the full assessment has been successfully completed, the final approval decision is

made by the DRRS which is officially endorsed by the director of the authority.[5, 6]

Figure: 3 Regulatory Process of Kuwait

REGULATORY PROCESS OF BAHRAIN

Bahrain has a unique medicines policy that clearly states the aims, the current situation and

the objectives of the Bahraini medicines control system. It is called the “Bahrain Medicines

Policy- BMP”. The goal of the policy is to serve as a guide for action and commitment to

provide good quality, safe, and effective medicines which are rationally used and provided at

reasonable costs for the people in Bahrain, and for coping with new developments in the field

of pharmaceuticals[7]

Company

registration

Sponsor submit

dossier with price

certificate

Receipt &transfer

to registration

department

Queuing for

reviews

Scientific assessment

& price negotiation

For nauseas registered in

competenter authorities

EAS not registered in

competent authorities

sent to QC lab sample

analysis

Queries are

sent to sponsor Interaction

with sponsor

Approval

decision is made

Sponsor pays

fees &receives

registration

Pricing is approved

by health minister

Product is marketed


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Initially, the sponsor submits the product registration dossier with the complete documents

for the official acceptance of the dossier to be made. The authority did not specify

information about the logistics involved at the receiving stage.

Items are checked accordingly,

1. Legal status of applicant/local agent

2. GMP status of manufacturer

3. Patent/IP status of active ingredients

4. Acceptable format of the application

5. Organized format of the registration dossier including the three sections of scientific data.


When the product enters the scientific assessment stage, the dossier is split into three

sections, which are assessed in parallel by the appointed reviewer who completes a product

assessment template and collects all the resulting questions as they arise during the review

into one batch for the sponsor including the laboratory requirements.


The pricing process is the final step and price negotiations occur at the end of the scientific

assessment. The sponsor is informed of a positive scientific opinion within 90 days of issuing

the authorization.[8]

Fig: 4 Regulatory Process of Bahrain

Sponsor makes

submission

Receipt and

validation

Accepted for

review

Queuing for

review

Scientific

review starts

Sponsor processes

questions & responds

Full report raised to

registration committee Price negotiations Sample analysis

Registration

approval

Product marketing

authorization


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REGULATORY PROCESS OF OMAN

The regulatory review process in Oman comprises ten stages which are considered critical

and have an impact on the approval time of medicines


The sponsor submits the product registration file to the authority. All documents must be

completed for official acceptance. The following items are checked at the validation stage,

1. Legal status of the applicant/local agent

2. GMP status of the manufacturer

3. Organization of the registration dossier

4. Certificate of a Pharmaceutical Product (CPP) authenticated by the respective embassy or

consulate general.

The Evaluation Stage

There is a formal record for the starting time of the scientific assessment. In the primary

scientific assessment procedure, an internal reviewer in the drug control department

completes a scientific product report, detailing the trade, generic names, indication and

country of origin.


The registration committee is responsible for granting the marketing authorization and

pricing of the product after completion of the review process.[9]

Fig: 5 Regulatory Process of Oman

Sponsor makes

submission

Receipt and validation Accepted for

review

TCR&P

committee

Scientific assessments

starts

Queuing for

review committee

procedure starts

Questions are sent to

sponsor in one batch

Questions are processed

and reply sent back to

TCR&P committee

TCR&P

decision making

Approval granted


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REGULATORY PROCESS OF QATAR

The regulatory review process in Qatar is illustrated in consists of thirteen critical steps that

have an impact on the overall time of patient access to the medicines.


The regulatory process in Qatar begins with the sponsor submitting the registration dossier to

the department containing the complete documents for a successful and timely review

process. Must be checked at the validation stage for the file to be accepted for review, these

are.

1. Legal status of the applicant/local agent

2. GMP status of the manufacturer

3. Patent/IP status of the active ingredient

4. The CPP authenticated by the respective embassy or consulate general

5. The complete dossier in the acceptable format

Evaluation Phase

During the scientific assessment process, the registration dossier is split into quality, safety

and efficacy and the appointed reviewer, who is a technical staff member, reviews all parts in

parallel.


The final report is sent to the registration committee for their review, which, on their

agreement, makes the final decision to grant the product marketing authorization.[10]

Fig: 6 Regulatory Process of Qatar

Sponsor makes

submission

Receipt and

validation

Accepted and

transferred to registered

unit

Queuing for review Scientific review starts Questions are sent

to sponsor in one

batch

Sponsor processes

questions and responds

to authorities

Response received and

evaluated by registration

unit

Report sent for

registration

committee

Registration

approval granted

Price negotiations

and agreement

completed

Patients access to

medicine


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REGULATORY PROCESS IN THE KINGDOM OF SAUDI ARABIA (KSA)

The regulatory review process for medicines in Saudi Arabia is carried out in the newly

established autonomous “Saudi Food and Drug Authority” The review process comprises

thirteen steps which are critical to the whole process.


The authority’s approval process starts with the sponsor submitting the product registration

dossier to the authority online. The applicant has to pay the application fees in order to

submit the application form and schedule an appointment to deliver the hard and electronic

copy of the product file. The sponsor must ensure that the dossier contains the complete

documents for it to be officially accepted for assessment.


The authority’s technical staff carries out the scientific assessment process. Different

procedures are carried out in different sections and departments particularly for New

Chemical Entities (NCEs) and biological products. In the scientific assessment stage, the

reviewing staff assesses the quality, safety and efficacy data in parallel.


Towards the end of the scientific assessment, the authority requests the sponsor to submit the

price list outlining the price of the product in countries where it is marketed.[12, 13]

Fig: 7 Regulatory Processes in the Kingdom of Saudi Arabia (KSA)

Sponsor makes

submission and pays fees Receipt and validation

Acceptance

for review

Queuing for review Scientific assessment starts Report sent to

scientific

comittee

Scientific

committee advisor

Questions collected into

batches sent to sponsor

Sponsor process

questions and

provide answers

Completion of

sample analysis

Price

negotiation

s

Scientific

committee approval

decision

Approval

granted


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REGULATORY PROCESS IN THE UNITED ARAB EMIRATES (UAE)

The regulatory review process in UAE consists of twelve critical stages that are considered

essential and comprise a significant part of the review procedure.


The sponsor submits the registration dossier, which must contain all the required data to pass

the validation stage and become accepted for review. An appointment is then arranged with

the department’s administrative staff to submit the product for registration and an

appointment sheet and evidence of the manufacturing site registration must be presented at

this stage.

1. Legal status of applicant/local agent

2. Patent/IP status of the active ingredients

3. Evidence of payment of the relevant fees


The dossier is split into the three sections; quality, safety and efficacy; which are all reviewed

together by the same appointed reviewer. The reviewer must complete a product evaluation

template and print all the resulting requirements into one report for the sponsor.


The higher registration committee is the committee that is responsible for granting the final

approval for a product, which is of political and administrative rather than of technical

membership. The registration committee reviews the scientific committee report and makes a

decision to grant marketing authorization for a product accordingly. [14, 15]

Fig: 8 Regulatory Processes in the United Arab Emirates

Sponsor makes

submission

Receipt and

validation

Accepted for

review

Queuing for review Scientific review

starts

Questions collected

and result to sponsor

Registration and

approval granted

Price negotiation

agreement

Marketing

authorization


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Table: 2 Data requirements of different regions registration requirements in Saudi

Arabia, Bahrain, Kuwait and UAE [16]

Saudi Arabia Bahrain Kuwait UAE

For

mat

CTD format. eCTD

recommended.

Module 2 to 5:a/c to ICH

CTD format. Module 1:

regional requirements:

• Cover letter

• Table of contents

• Application form

• Product information:

Summary of product

Characteristics (SMPC),

product information

leaflet

(PIL) and labeling all in

WHO template format.

•Information on experts

involved in clinical,

nonclinical studies.

•Environment risk

assessment.

• Pharmacovigilance

•Certificate of

pharmaceutical product

(COPP)

• Pricing

•Response to questions

asked by SFDA (in any)

Company profile

• Number of manufacturing

sites owned by company

• Address of each site

• Legal &commercial

relations with all sites

• Manufacturing license with

date in country of origin

(COO).

• Address of applicant with

contact details.

• GMP certificate from

country of origin.

• Number of employees in

different section

& their qualification details.

• Graphic design & flow of

manufacturing line of site.

• List of all products

manufactured at company’s

site or Contract

manufacturing

Organization or other

marketing authorization

holder.

• Relationship MAHs.

•Any previous inspection by

GCC health authorities or

Arab health authorities

• Reference

standard with

COA.

• Finished product

sample.

• Patient

information

Leaflet (English

and Arabic).

• Source of supply

of API and

inactive

ingredients.

• Raw material

specifications.

• Finished

products

specifications with

quality control

Methods.

• Stability data:

• Long term3

batches

• Accelerated

studies: six

months, same

three batches, used

for long term

studies.

• Bioequivalence

Study data

Distributor of

product in

UAE.

•

Manufacturing

Site.

• Marketing

authorization

Holder &

power of

attorney.

• Manufacturer

of API.

• Regulatory

status.

• Price list.

• Declaration

(In accordance

with the

medicines’

regulations of

Drug Control

Department-

Ministry of

Health -UAE)


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Enclosures required for drug registration in five Gulf Cooperation Council countries

Cert

ificat

es

Authenticated

by the

Ministry of

health of the

country of

origin and

additionally

by Saudi

Arabian

Embassy.

Following

Certificates

required:

• COPP/ free

sale

Certificate.

• COA.

• Pork-free

Declaration.

• Price list

Contents of file

• WHO-certificate of pharmaceutical product

issued by country of origin and legalized by any

one GCC embassy.

• Summary of product characteristics (SMPC).

• Separate file for quality control laboratory

including all quality data and information e.g.

certificate of analysis, validation report etc.

• Full description about API, and excipients.

• Description about vehicles and carriers used.

• Method of manufacturing.

• Name and address of involved CROs (if any).

• Description of outer pack and accessories used.

• Concentration of product (per unit mass or

volume).

• Source of starting material.

• Proposed label.

• Product patient leaflet (Arabic/English).

• Toxicological data (for NCE and newly

introduced generic drugs only).

• Bioequivalence study reports (generic drug)

• Animal source (if any).

• Price certificate authenticated by health

authorities of country of origin

Distributor of

product in

UAE.

•

Manufacturing

Site.

• Marketing

authorization

holder and

power of

attorney.

• Manufacturer

of API.

• Regulatory

status.

• Price list.

• Declaration

(In accordance

with the

medicines’

regulations of

Drug Control

Department-

Ministry of

Health -UAE)

S.No Enclosures KSA Kuwait UAE Oman Bahrain

1. Control specification & method of analysis R R R R NR

2. Certificate of analysis attested by health

authority and country of origin R NR R NR NR

3.

Legalized free sale certificate issued by

health authorities for COO, indicating that

product register & market with same name &

composition

R R R R R

4. Legalized certificate indicating that diluents

used are allowed to be in COO R NR NR NR R

5.

Legalized price certificate issued by

component authority of COO &attested by

embassy including ex-factory price,

wholesale price COO

R R R NR R

6. Retail/Public Price In COO R NR R NR R

7. Export price to country and neighboring

countries R NR R NR R

8. Stability studies in various defined

conditions R R R R R

9. Storage conditions R R R R R

10. Name of developed countries in which the

product is registered R R R R R


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R: Recommended by regulatory authority, NR: Generally, not recommended by regulatory

authority

SUMMARY

The main requirements for our study is usually a local representative, a Certificate of Free

Sale from the country of origin, import license from the competent authority in the import

country, registration of the company and the product. To accomplish this, it is necessary to

fulfil the essential principles, classify the product, apply Good Manufacturing Practice and

risk management, follow the labelling requirements and establish a documented post-market

surveillance system. Technical documentation is also necessary and in most cases that can be

submitted with the registration application. From the above comparative study it, can infer

that “regulations for the safety of patient is same but rules and procedures followed to

implement that are different”, due to this reason a common framework & format like CTD

cannot be implemented though the submission of the document is made electronically.

11. Abstract from scientific reference about

product R R R R R

12. Sealed sample of product and copies of label R R R R R

13. Quantity specified for each pack and outer

pack of product R R NR NR R

14. Leaflet in Arabic and English including

A Name of product R R R R R

B. Composition R R R R R

C. Mode of action R R R R R

D Effect R R NR R R

E Indications R R NR NR R

F Contraindications R R NR R R

G Precautions R R NR R R

H ADR R R NR R R

I Antidote R R NR NR R

J Dosage and administration R NR NR R R

15 Product labeling R R R R R

16 Bio availability studies R R R R R

17 Scientific basis of justifying the formulation

of combination product R R R NR NR

18 Post market surveillance R NR NR NR NR

19 Certificate of sterility and pyrogen free

pharmaceutical product NR R R NR NR

20 Copy of reference pharmacopoeia R R R NR NR

21 CTD format for dossier submission R NR NR NR NR

22 eCTD R NR NR NR NR


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CONCLUSION

From the above study we have concluded the registration procedure may differ in minor

variation and there are further needs for harmonization so the applicant does not modify the

individual format & the information will become unambiguous and the transparent to

facilitate the review and help a reviewer to become quickly oriented. Information collected

and analyzed from each country’s regulatory system for GCC (Gulf co-operation council

countries) pharmaceuticals brings to view the difficulties encountered in each of them. Most

of the countries have similar requirements for registration of pharmaceuticals and are striving

to harmonize their requirement guidelines. The essential principles are mainly the same in

most of the countries studied, but there are some differences and therefore it is necessary to

look at these requirements country by country. The price controls and IP regime favor

domestic and regional production, which may stint foreign investment in the sector.

ACKNOWLEDGEMENT

I express my gratitude to my family members for their support throughout my work. It’s my

immense pleasure to express my deep sense of gratitude and sincere thanks to Chalapathi

Institute of Pharmaceutical Sciences family for their valuable suggestions and continuous

encouragement to complete my work successfully.

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