A Review on the Centralised Registration Procedure in the Gulf Cooperation Council (GCC) Region

 

Umar Khan. S, R. Kamaraj

Department of Pharmaceutical Regulatory Affairs, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur – 603203, Kanchipuram, Tamil Nadu, India

 

ABSTRACT:

Regulatory Affairs (RA) is a profession which acts as the interface between drug regulatory authorities and regulated industries such as pharmaceuticals, medical devices, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also have a peculiar meaning within the healthcare industries (pharmaceuticals, medical devices, biologics and functional foods). The Gulf Cooperation Council (GCC) region is treated as “emerging market” for pharmaceuticals when compared to another region. The objective of this study was to consider regulatory authorities of each states of GCC (Saudi Arabia, UAE, Bahrain, Kuwait, Oman, Qatar, Yemen) and pharmaceutical association perspective in the locality to evaluate review process, quality and effective measures used to improve the duration and approval process to determine the assets and liability of the centralized registration procedure.

 

 

 

INTRODUCTION:

The Gulf Cooperation Council (GCC) is also established as the Cooperation Council for the Arab States of the Gulf (CCASG). It is a governmental and commercial conciliation of the Arab county verging the Persian Gulf and composing the Arabian Peninsula. It composed of six union states Kuwait, Saudi Arabia, Oman, Bahrain, United Arab Emirates and Qatar and usually regarded as “The GCC States”. In November 1981, establishment of the cooperative commercial reconciliation compromising each state of GCC approved in Abu Dhabi [1]. Being thoroughly familiar of the link of specific relationship, routine observance and related scheme established on the faith of Islam which adhere them and yearning to outcome designation, collaboration and assimilation between them in all expanse and having the confident that designation, collaboration and assimilation between them provide the divine intention of the Arab Nation [2].

 

It comprises of about 2, 672, 700 km² of total area. The formal speech is Arabic.  GAFTA known as Greater Arab Fee Trade Area, in which each state of GCC and Yemen are members of GAFTA. As of late, Jordan and Morocco have affirmed for the GCC collaboration which is a little while later being considered by the GCC expert leading trustees[3].

 

OBJECTIVES OF GCC:

1.      To attain designation, assimilation and interrelationship between member county in all expanse to attain harmony between them

2.      To elaborate and exaggerate rationality, network and range of designation between their society in various expanse

3.      To develop conscientious governance in discrete expanse including the following:

A.     Commercial and fiscal matters

B.     Trade, characteristics and transmission

C.     Civilization and elegance

D.     Communal and robustness matters

E.      Intelligence and touristry

F.      Parliamentary and regulatory matters

4.      To expedite perceptive and specialized process in the expanse of corporation, preserve cultivation, water and natural wealth: to experimental investigation: to designate collective investment and strengthen designation by the independent sector for the favor of their community [4].

 

 

Figure 1 Flag of GCC (Gulf Cooperation Council) [4]

 

Figure 2 Map of the GCC region

 

Table 1: Demographic structure of GCC states

Country	Bahrain	Kuwait	Oman	Qatar	Saudi Arabia	UAE
Flag
Capital	Manama	Kuwait	Muscat	Doha	Riyadh	Abu Dhabi
Language	Arabic	Arabic	Arabic	Arabic	Arabic	Arabic
Area/km²	760	17,818	309,500	11,586	2,149,690	83,600
Population	1,234,571	2,672,926	2,773,479	1,715,010	27,563,432	8,264,070
Population density	1696/km²	223/km²	13/km²	210/km²	16/km²	116/km²
GDP	31.13 billion	114 billion	69.8 billion	164.64 billion	646 billion	370.3 billion
GDP per capita	22,710	28,700	16,800	67,500	20,800	48,330
Total foreign trade	33.1 billion	85.04 billion	63.9 billion	109.9 billion	378.2 billion	352.1 billion
Exports	16.7 billion	54.1 billion	34.9 billion	77.3 billion	203.6 billion	167.9 billion
Imports	16.4 billion	30.95 billion	29 billion	32.6 billion	174.7 billion	184.2 billion
Oil reserves	0.12 billion barrels	102 billion barrels	5.2 billion barrels	25.2 billion barrels	266 billion barrels	98 billion barrels
Gas reserves	92 billion feet³	1,784 billion feet³	931 billion feet³	24,299 billion feet³	8588 billion feet³	6,091 billion feet³

 

 

Figure 3 Organizational structure

 

 

 

Table 2: Regulatory authorities of GCC member states [5]

COUNTRY	AUTHORITY
Kingdom of Bahrain	Pharmacy and drug control department, Ministry of Health
State of Kuwait	Drug and food control department, Ministry of Health
State of Oman	General directorate of pharmaceutical affairs and drug control, Ministry of Health
State of Qatar	Pharmacy and drug control department, Ministry of Health
Kingdom of Saudi Arabia	Saudi food and drug authority
United Arab Emirates	Registration and drug control department
Yemen	Supreme board of drugs and medical appliances

 

Drug Registration in Gulf Cooperation Council states:

In May 1999, the Gulf Central Committee for Drug Registration (GCC-DR) was established with six middle Eastern nations – Oman, Saudi Arabia, Qatar, United Arab Emirates, Kuwait and Bahrain. In 2003, Yemen became the 7^th member of the GCC-DR. The objective of the GCC-DR works together to review/accept pharmaceutical association and drugs by means of a centralized registration procedure to provide the seven states of GCC mutually safe and effective medicines with a reasonable price [6]. The developing GCC drug pharmacy market is enduring a sea change, by all of governments in enforcing reforms, elucidating regulations and alleviating and acquiring healthcare framework to concur with the global pharmaceuticals market. In 2020, the health protection convenience shop is expected to climb from predicted US$ 40.2 billion which is anticipated to reach US$ 71.2 billion at 12.1% increase in compound recurrent price. In 2015 from US$ 24 billion, the victim will be anticipated to reach US$ 42.4 billion in 2020. The healthcare advertises in each state of GCC are eventually surge every year by moderate value of 11-13% of instant before 2020. Most of the pharmaceutical and health care products are imported habitually by UAE. To overcome clinical trials, combined exertion is carried out to localize formulation of pharmaceuticals and fascinate proficient medicinal experts. [7].

 

GCC Regional Harmonization Process:

Ÿ  The GCC-DR especially opt ICH guidelines as the support for establishing provincial guidelines

Ÿ  Other global guidelines including WHO, as well as preferred territorial (e.g., EU, American sub-regional)

Ÿ  Nationwide scientific evidences are also operated as support for harmonization and as attribute substantial

Ÿ  Previously prepared by a functioning body, a draft guideline is distributed to each state for review

Ÿ  The draft report is also placed on the site to promote discussion from shareholders

Ÿ  The functioning body examine all opinion acquired, and endorse the acceptance of the guideline to the GCC-DR Steering Committee

Ÿ  previously approved by the GCC-DR Steering Committee, the Director General of the Executive Office will acknowledge the guideline to the CMH for final approval [8].

 

Scope of GCC drug regulatory activities

Ÿ  Pre-marketing evaluation

Ÿ  Post-marketing review

Ÿ  GMP inspection

Ÿ  Marketing authorization

Ÿ  Technical guidelines [8].

 

GCC-DR Responsibilities

Ÿ  Pharmaceutical company’s registration

Ÿ  Pharmaceutical product’s registration

Ÿ  Approval of Quality Control Laboratories (QCL)

Ÿ  Inspection for GMP compliance in pharmaceutical companies

Ÿ  Reviewing of Technical and PMS reports [9]

 

Overview of Saudi Drug Registration [10]:

 

Figure 4

 

Figure 5

 

 

Figure 6

 

 

Figure 7

 

 

Figure 8

 

Figure 9

 

 

Figure 10

 

 

Figure 11

 

Figure 12

 

 

Figure 13

 

REGISTRATION PROCEDURE:

Gulf Cooperation Council regulatory authorities which is in the executive office of Heath ministers, Riyadh, Saudi Arabia, in May 1999.

 

Drug registration:

Drug registration process is carried out in the following two processes

Ÿ  Centralized procedure

Ÿ  Decentralized procedure

 

Centralized procedure:

The executive office of GCC-DR after ensuring the fulfillment of registration requirements assumes the receipt of enrollment files and filling the following forms:

Ÿ  Registration form of the pharmaceutical company

Ÿ  Registration form of the pharmaceutical preparation of the chemical entity

Ÿ  For each chemical entity, 8 complete files & 17 sample must be submitted to the regulatory authorities and along with the registration file, 2 sample must be dispatched to each state.

 

Decentralized procedure:

Drug enrollment guidance in major states of GCC, despite there is harmonized and centralized process for drug registration in the seven states of GCC, the requirements for approval of drug products in major countries like Saudi Arabia and UAE are independent. These countries have their congenital regulatory system and its prosecution [12].

 

GCC-CP (Centralized procedure):

The originate before being implicated to enlist a medicinal production vary from nation to nation and shows difference between products. Matter what it may, it is helpful to supplement the survey procedure inside an aggressive time if the report is available and satisfactory. Numerous nations have administrative limitation time support the audit of a dossier. Various difficulties confronted by GCC wellbeing specialists to effectively work the unified framework. The GCC-DR stand up to in the first place was to substantiate organizations to approach presenting their dossiers for this methodology. Pharmaceutical organizations additionally have blended emotions moving toward whether they can get speedier showcasing approval over the national organizational frameworks or the incorporated territorial framework. After by and large, the want of the whole pharmaceutical organization is to finish the enrollment prerequisites and access the national GCC advertises in the most limited practical time.

 

Principle highlights:

·        Support the primary framework of GCC-DR incorporated methodology

·        Alter the component that are tedious in the present GCC-DR incorporated methodology

·        Grant all states to take an interest in the audit procedure and the decisions came to in an opportune way

·        Endorse a computerized arrangement of audit for the suggested model to conquer rarity of gatherings and the likelihood of all seven nations partaking in the survey procedure in a isolated way

·        Maintain computerized correspondence with candidates for inadequacies for enhanced survey progress

·        Maintain a clock-quit calibrating for the audit procedure considering the mechanization of the survey procedure

Phase 1: Receipt:

Receipt of the submission is made in agreement to the distributed GCC rules for NAS's and EAS's. The candidate should ask for an accommodation date for the submission which would be indicated by the GCC office. It arises out of significance that the candidate would give an announcement that the submission being purposed has checked complete pertinent GCC rules. This announcement functionally affects the clock-stop as it is as often as possible watched that candidates submit mostly finished dossiers, particularly the neighborhood business, making guarantees to bring absent or finish information later. The candidate must be considered responsible in such cases and this must be finished by nearby laws if such reports are granted. Generally, the getting officer will be as a rule be considered mindful. Besides, the announcement will fill in at time zero for the "clock-stop". The receipt procedure ought to be led at the GCC Official Office and implemented by GCC staff. This stage is held as the present routine with regards to submission receipt at the GCC office.

 

Phase 2: Validation:

The validation stage might be rudimentary for offices like Wellbeing Canada, US FDA or EMA, when numerous documents are presented by the candidate through which the accommodation is concealed to guarantee that the information are finished and of appropriate aspect for audit. In this stage, for the GCC-CP, the necessities are analyzed opposite to the challenge for legal prerequisites. This ought to incorporate regulatory enlistment (enrollment number) and takes care of legitimate prerequisites, the status of the organization, makers and so on., and in addition an 'agenda' approval of the submission content (e.g. specialized, CPP status)

 

 

Figure 14 Proposed model for GCC-CP registration system

 

 

Figure 15 Current model for GCC-CP registration system

Additionally, keeps an eye on patent consistence are fundamental and an authoritative course of action, for example, contract fabricating, or authorizing understanding is likewise evaluated. The designated clock-stop time for the two procedures of regulatory and lawful conventions ought to be 30 days. The approval forms are organized in the GCC office. As a result, the approval procedure should assure that the designed application takes after the recommended prerequisites as expressed in Module 1 of the CTD together with additionally watches that all the mandatory specialized information is required. This stage is made away as the present routine with regards to application approval by the GCC office.

 

Phase 3: Review:

The logical appraisal organize is the significant piece of the audit procedure and needs a lot of assessment of information pertinent to the security, viability and nature of the pharmaceutical product. Hence, it is fundamental to concentrate on giving the proper ranges of abilities and the offices and additionally setting up rules, SOPs, preparing and proceeding with training programs and the electronic treatment of the audit procedure to actualize the coveted good review practices (GRPs). In the new suggested model, the logical survey ought to be redesigned to permit all states to take an interest in the audit procedure in a ones-advance of the proposed demonstration. In this stage, two boards are created from all states. In this way, every county is contained in each of the two advisory groups to guarantee the dynamic investment of all domain. The two boards are as per the following:

 

Clinical board:

This board should comprise of specialists from each states and ought to oversee evaluating the clinical prerequisites for both NAS's and EAS's summary. This panel is worried about wellbeing and viability/modules 4 and 5 of the endorsed GCC CTD model.

 

Technical board:

This board should comprise of specialists from each state and ought to oversee exploring and affirming APIs and excipients in the recipe and in addition the completed item. This advisory group is fundamentally the same as the EDQM panel in the EU notwithstanding the specialized survey council in regard EU part states. This advisory group would have concentrated on module 3 of the GCC CTD standard.

 

Clinical and specialized boards of trustees cover all perspectives about the security, adequacy and nature of the item while any lawful angle that may identify with the item would have just been analyzed amid the submission approval process. Clinical and technical board’s way to deal with the item's survey contrasted with the two-advance access of the present standard would prompt impressive time funds and audit process effectiveness and straightforwardness. A letter of lack of identifying with that board of trustees would be issued to the candidate with a period confine for the candidate to react. Board's gathering time can be composed in a way to take into consideration the survey of original submissions while managing around 30% of the gathering moment for answers to issue letters of inadequacy. The board of trustees should assign in any event earlier a month to manage the procedure effective and opportune. Apportioned clock-stop time for the two advisory groups simultaneously is 150 days. Assignments performed in the boards of trustees are done basically by the individual from staff with wellbeing experts in each state and not from the GCC office staff.

 

Laboratory study:

The enforced lab tests ought to be implemented simultaneously with the submission survey procedure of both clinical and technical boards. The apportioned clock-stop time for the research facility to finish the recommended errands is 120 days that are quite inside the 150 days clock-stop time dispensed for both clinical and technical boards. This ought to be the delinquency and suggests that crafted by both clinical and technical boards and the laboratory is fit and harmonized to finish the effort inside the 150 days restrains.

 

Phase 4: Approval:

Previously the two boards give endorsement as far as concerns them and in addition the laboratory choice to support the product, their separate choices are forwarded to the head of experts meeting to give the endorsement to issue the enlistment authentication. If, for any reason, the leader of the experts is concerned with respect to any part of the submission they will intimate a letter of worry to the suitable association that may be the GCC administration faculty, determined boards of trustees, the research center or the candidate. Once the worry is addressed then a direction to issue the enlistment testament is ordered. The leader of specialist's endorsement is tantamount to watch that the endorsement procedure steps and a sufficient survey is watched. This may speak to a quality affirmation assignment execution to ensure complete survey rehearses at the GCC office. The distributed clock-stop time for this stage ought to be 30 days and the assignments are endowed at the head of wellbeing experts in the GCC each state. The head of experts in such situation is expected to be viewed as the endorsement committee (head of offices) and they should assign, each occasion. The designated clock-stop time for this council is 30 days.

 

Table 3: Registration fees in the GCC States

Country	Bahrain	Kuwait	Oman	Qatar	Saudi Arabia	UAE	Yemen	GCC-CP	Proposed GCC-CP fees
Company Registration	5BD=USD13.3	250KD =USD 887.2	100O= USD259.7	NO FEE	(ONLY INSPECTION FEE)	1000DH= USD 272.3	3000 USD	10000SR= USD 2,667.5	(ONLY INSPECTION FEE)
Products NASs	5BD= USD 13.3	100KD =USD 354.9	75OR=   USD194.8	NO FEE	95,000SR= USD25,340.8	1000DH= USD272.3	1500 USD	10000SR= USD 2,667.5	USD 30,4444*
Products EASs	5BD=USD13.3	100KD =USD 354.9	75OR= USD194.8	NO FEE	40,000SR= USD10,669.8	1000DH= USD272.3	1500 USD	10000SR= USD2,667.5	USD 14,305*

*The suggested fees system determined corresponding to the rate of present governmental fees to the overall fees for all county in inclusion to 10% as administrative fees

 

This considers the gathering recurrence of this board of trustees ensuring that once the submissions pass all asked for legal and authentic necessities the submission’s last endorsement by the head of specialists should be consistent with the clock-stop. Once the endorsement is conceded by the endorsement board then the GCC office should contribute the enlistment testament for the item under submission.

 

It is suggested that if the suggested paradigm is embedded then each state should decrease their governmental charge for GCC-CP fee and that the GCC-CP fee ought to be compiled among each states offer is ascertained by the proportion of present national fee to the aggregate fee for all states notwithstanding 10% as organization charge. For this standard to be possible later, the general fee of the GCC-CP must be expanded. The expanded fee would permit part wellbeing specialists to profit by these submission fee and for undertaking they execute amid the submission endorsement system. Further to the over, the fee for examination ought to be granted to the doled-out QC laboratory in each state playing out the investigation undertaking. The preparation fee ought to be granted to each state facilitating the preparation movement. The correlation of the perspectives from medicinal organizations and administrative specialists has distinguished the most imperative result as the want for enhancing the GCC centralized procedure model. [13].

 

GCC – Regulatory process maps:

All the GCC experts share comparable objectives and commitments to protect general wellbeing while surveying the security, nature and viability of prescriptions since they are approved for showcasing. Likewise, they have a comparable system while surveying pharmaceutical item dossiers, however the aspect of every point of reference in the audit procedure varies starting with one state then onto the next

 

 

 

Fig. 16 Regulatory Process of Bahrain [14]

 

 

Fig. 17 Regulatory Process of Oman

 

 

Fig. 18 Regulatory Process of Kuwait [15]

 

 

Fig. 19 Regulatory Process of Qatar

 

 

Fig. 20 Regulatory Process of Saudi Arabia [16] [17]

 

 

Fig. 21 Regulatory Process of UAE

 

Table 4: Responsibilities of the regulatory authorities of each state [11]

Country		Bahrain	Kuwait	Oman	Qatar	Saudi Arabia	UAE	Yemen
Name of Authority		National Health Regulatory Authority	Kuwait Drug and Food Control	The Directorate General of Pharmacy and Drug Control	The Pharmacy and Drug Control Department	Saudi Food and Drug Authority	The Registration and Drug Control Department	Supreme Board of Drugs and Medical Appliances
Autonomous authority		X	X	X	X	√	X	√
Budget/GBP		NA	2million	NA	NA	85million	1.6million	2million
Fees/GBP		9	230	130	None	>5000	NA	470
Scope of registration responsibilities	Medicines for human use	√	√	√	√	√	√	√
	Veterinary medicines	X	√	X	X	√	√	√
	Medical devices and in-vitro diagnostics	√	√	√	√	√	√	X
	Cosmetics products	X	√	X	X	X	X	X
	Food supplements	X	√	X	X	X	X	X
	Herbal medicines	X	√	X	X	X	X	X
Scope of activities	Marketing authorization	√	√	√	√	√	√	√
	Post-marketing surveillance	√	√	√	√	√	√	√
	Sample analysis	√	√	√	√	√	√	√
	Advertising control	X	√	√	X	√	√	X
	Price regulation	√	√	√	√	√	√	√
	GMP inspection	_	√	√	X	√	X	X
	Clinical trial authorization	√	X	X	X	√	√	X

 

Table 5: Standard estimation and aspect in the Gulf States

*NA=Not Applicable

 

Table 6: Data and submission requirements of different regions

	Saudi Arabia	Bahrain	Kuwait	UAE
Format	CTD framework         e CTD suggested. Module 1: territorial prerequisite: ·  Cover letter ·  Table of contents ·  Application form ·  Product information: Summary of product characteristics (SmPC), product information leaflet (PIL) and labelling all in WHO template format. ·  Knowledge on professional involved in clinical, nonclinical studies. ·  Environment risk assessment. ·  Pharmacovigilance ·  Certificate of pharmaceutical product (COPP) Module 2 to 5: a/c to ICH CTD format	Company portrait: ·  Number of manufacturing sites developed by company ·  Address of each state ·  Proper & financial links with all sectionc ·  Manufacturing exemption with period in country of origin (COO) ·  Location of claimant ·  GMP credential from provincial source ·  Expanse of laborer in various area & their qualification evidence ·  Graphic design & flow of manufacturing line of site ·  List of all products manufactured at company’s site or Relationship MAHs	·  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 term 3 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 medicine’s regulations)
Certificates	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 (COPP) 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 (for generic drug registration)		Distributor of product in UAE ·  Manufacturing authorization holder and power of attorney ·  Manufacturer of API ·  Regulatory status ·  Price list ·  Declaration (In accordance with the medicine’s regulation of Drug Control Department-Ministry of Health-UAE

 

 

Table: 7 Enclosures required for drug registration in five Gulf Cooperation Council countries

S. no	Enclosures	Bahrain	Kuwait	Oman	Saudi Arabia	UAE
1.	Control specification and method of analysis	NR	R	R	R	R
2.	Certificate of analysis attested by health authority and country of origin	NR	NR	NR	R	R
3.	Legalized free sale certificate issued by health authorities for coo, including that product registered and marketed with same name & composition	R	R	R	R	R
4.	Legalized certificate indicating that diluents used can be in coo	R	NR	NR	R	NR
5.	Legalized price certificate issued by component authority of coo & attested by embassy including-factory price, wholesale price coo	R	R	NR	R	R
6.	Retail/Public Price in Coo	R	NR	NR	R	R
7.	Export price to country and neighboring countries	R	NR	NR	R	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
11.	Abstract from scientific references 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	R	NR
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	R	R	NR
E.	Indications	R	R	NR	R	NR
F.	Contraindications	R	R	R	R	NR
G.	Precautions	R	R	R	R	NR
H.	ADR	R	R	NR	R	NR
I	Antidote	R	R		R	NR
J.	Dosage and administration	R	NR	R	R	NR
15.	Product labelling	R	R	R	R	R
16.	Bioavailability studies	R	R	R	R	R
17.	Scientific basis of justifying the formulation of combination product	NR	R	NR	R	R
18.	Post market surveillance	NR	NR	NR	R	NR
19.	Certificate of sterility and pyrogen free pharmaceutical product	NR	R	NR	NR	R
20.	Copy of reference pharmacopoeia	NR	R	NR	R	R
21.	CTD format for dossier submission	NR	NR	NR	R	NR
22.	e CTD	NR	NR	NR	R	NR

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

 

 

CONCLUSION:

From the above study, we have concluded that the registration procedure of drug products may slightly differ from countries/regions. The primary challenges in drug registration process are observed and for success in the region is knowledge of the drug registration process and submission content of a region is essential for the effective planning and execution of global regulatory strategy. In seven states of the Gulf Cooperation Council, GCC-DR plays a major role in reviewing and approving pharmaceutical companies and their drug products. Generally, the seven states of GCC have similar requirements for registration of pharmaceuticals and are making efforts to harmonize their requirement guidelines. The results demonstrated that the GCC-DR centralized procedure has contributed to a better review process both at the GCC-DR and national level. The GCC-DR must be revised and developed to an independent marketing authorization granting authority providing applicants with one license that covers all seven Gulf States. A novel model of GCC-DR CP (Centralised Procedure) has been proposed which should resolve many of the difficulties facing GCC-DR currently and should improve its effectiveness and efficiency.

 

ACKNOWLEDGEMENT:

Authors want to acknowledge the management of SRM College of Pharmacy, SRM Institute of Science and Technology for their valuable support.

 

AUTHORS CONTRIBUTION:

Umar khan – Conceptualisation of work, interpreted data, wrote manuscript

Raju Kamaraj – Supervised the development of work and manuscript evaluation and acted as corresponding author

 

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Accepted on 17.07.2018        © RJPT All right reserved

Research J. Pharm. and Tech 2018; 11(12): 5653-5668.