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Central Drug Registration

العربية تحت رعاية صاحب المعالي وزير الصحة المهندس خالد بن عبد العزيز

Central Drug Registration

This is a unified GCC Health Council system for the registration of medicines, carried out by the Central Gulf Committee for Drug Registration. Its aim is to ensure the quality, effectiveness and safety of drugs, as well as the accuracy of information related to them. The system also ensures that medicines are manufactured in accordance with international standards.

 

Objectives:

- Unifying the registration of pharmaceutical companies in GCC countries.

- Unifying the regulations and procedures during the registration process

- Unifying the pricing of medicines marketed in GCC countries.

- Increasing integration and coordination amongst member states in the pharmaceutical field.

- Consolidating information and systems used when registering medicines.

- Ensuring the application of international-standard manufacturing facilities

- Monitoring the quality and side effects of registered and approved medicines

- Using the medicine optimally and at the lowest cost.

- Obtaining safe and effective medicine at affordable prices. 

 

Registration list of pharmaceutical companies and their products:

The explanatory list of the requirements and conditions of registration. 

 

Gulf Central Committee for Drug Registration:

Is the committee that was adopted to carry out the Central Drug Registration for the GCC according to Resolution No. (6) of the 45th Conference held in Geneva (Switzerland) in May 1998.


Committee members:

- Two members from each country.

- The chairmanship of the committee shall be carried out by one of the Member States and alternately each year according to the system of meetings of the Health Council. 


Functions of the Gulf Central Committee for Drug Registration:

- Registering drugs and pharmaceutical companies according to the unified registration regulations.

- Studying the technical reports received from Member States or the global commissions on the pharmaceutical companies and their products as well as taking the necessary measures.

- Adopting reports of analysis on pharmaceutical products issued by reference laboratories accredited in Member States.

- Determining the export price of pharmaceutical products to all Member States.

- Inspecting in the factories of pharmaceutical companies to ensure the application of the fundamentals of good medicine manufacturing.

 

Meetings of the Committee:​

​The committee holds (12) meetings, including (6) conference call meetings between technicians in countries to study the member countries registration files.  ​