Central Drug Registration

GCC-DR (GCC) drug registration was approved on 15^th May, 1999 and include Bahrain, Kuwait, Oman, Qatar, Saudi Arabia and the United Arab Emirates. Its Executive Office for Health Ministers is located in Riyadh, Saudi Arabia. The GCC-DR. committee consists of two members nominated by each state, the responsibilities of GCC DR. are:

1 - Registration of Pharmaceutical Companies.

2 - Registration of Pharmaceutical Products.

3 - Inspection of Pharmaceutical companies for GMP compliance.

4 - Approval of quality control laboratories.

5 - Review of technical and post market surveillance reports.

6 - Responsible for the Program of Bioequivalence study as a part of   quality assurance

  The Central Drug Registration  Policy

 1- Description and title of the committee

 The Title (Gulf Central Committee for Drug Registration- GCC-DR)

 2-  Determination of the assignments that shall be carried out by the Gulf Central Committee for Drug Registration

a.     Register the drug/medicine companies pursuant to the consolidated Registration Gulf Act.

b.    Register the pharmaceutical preparations pursuant to the consolidated Registration Gulf Act.  

c.     Study the technical reports coming from the member countries or the international organizations/ commissions about the drug companies, their preparations and taking necessary action towards them.

d.    Approve the pharmaceutical preparations analysis reports issued by the accredited reference laboratories in the member countries.

e.     Approve the drug analysis laboratories in the member countries.

f.     Fix the export price CIF for the pharmaceutical preparations for all the member countries.

g.     Inspect the drug companies factories in order to ensure their application of the good-practicing basis for the drug manufacturing pursuant to the Gulf Act.

 3-  The Members of the Committee: It is suggested to form the committee as follows

a.    Two members from each country.

b.    The Executive Office shall appoint two of its affiliates as advisors for the committee provided that they shall have no right for voting.

4- The validity of the central registration

 a.     The central Gulf committee’s resolutions for the drug registration shall be binding for the consolidated purchasing.

b.    All countries must sanction & approve the export price CIF which has been approved by the committee upon completion of the registration procedures in the country.

 6- Allocation of the referral laboratories for analysis

 The analysis shall be carried out in one of the reference laboratories accredited by the council’s countries.

 7- The Meetings

The executive council extends an invitation for the committee’s meeting if necessary.

 8- The procedural steps

 1-    The Executive Office shall assume developing a special secretariat for the registration of the drug companies and their products along with designating a place for the management/administration and the full time technical staff.

2-    The Executive Office shall assume receipt of the registration files after ensuring the fulfillment of the registration requirements pursuant to the consolidated registration Act and upon duly filling the following forms:

a.    The drug companies registration form.

b.    A pharmaceutical chemical entity/ preparation registration from.

3-    The company submits (8) complete files – for every chemical entity – to the Executive Office along with (17) samples and an internal brochure provided that two (2) samples shall be dispatched to each country along with the registration file which needs to be studied.

4-    The registration fee with the Executive Office shall be as follows:

a.    The companies registration shall be (Ten thousand Saudi   Riyals, distributed as follows)

       SR. 5.000 which shall be 50% of the registration fee against studying the company’s file.

       SR. 5.000 which represents 50% of the remainder registration fee  upon the final consent and approval for their registration.

b.    The registration of the chemical entity (Six thousand Saudi Riyals, distributed as follows: 

5-    Every country shall assume the study of the files- forwarded to it – and then return with its recommendations to the committee.

6-    The company shall provide the laboratory with the necessary needs & requirements for the analysis i.e. standard materials, analysis methods and others.

7-    The committee shall dispatch the samples of chemical entities – presented for registration to the reference accredited laboratories for analysis after recommending the approval of registration.

8-    The meeting shall be deemed legal if the number of countries represent in it – is not less than four countries.

9-    The committee’s resolutions shall be adopted  by the majority of the attendant member’s votes.

10- After approving the registration of the company or the chemical entity – centrally – the remainder authentication & documentation’s procedures & fees shall be finalized in every country as per its prescribed & established policies.

11- The Executive Office shall issue the companies registration certificates & their chemical entities in accordance with the decision of the committee.

12- The new companies – demanding registration – shall incur & bear the costs of the inspection team for visiting their factories inorder to ensure their application of the good exercises basis for the good manufacturing of pharmaceutical production (GMP)

13- The companies reserve the right to lodge their grievances to the Executive Office within a period of two months effective from the date of notifying them with the decision of the Gulf Central Committee for Drug registration.

14- The Executive Office will incur & bear all the costs of the central registration program for drugs and  propose the annual budget, deemed necessary for that.