It is a unified system for registering medical products (human medicines – medical devices – veterinary medicines) in the Gulf Health Council, to ensure the quality, effectiveness and safety of the medicinal product, the accuracy of the information related to it, and that it is manufactured in accordance with international specifications and standards. Among the most important goals that the Gulf Central Committees seek to register medical products to achieve are:

Unifying the systems and procedures related to the process of registering medical companies and their products in the GCC countries, as well as aiming to ensure that the principles of good manufacturing of medical products are applied, standardize the pricing of medicines marketed in the GCC countries, and activate the post-marketing follow-up program for medical products related to quality and side effects of products, which increases integration And coordination between member states in the field of medicinal products. The Gulf Products Classification Committee performs the classification process based on unified definitions and criteria.

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About

This is a unified GCC Health Council system for the registration of medicines, carried out by the Central Gulf Committee for Drug Registration. It aims 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 under 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.

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Gulf Central Committee for Drug 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.

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

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

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

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

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

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

About

Medical Device Registration

Medical device registration program is a harmonized medical device registration system in Gulf Health Council between all GCC countries. In our registrations system, no medical device is being registered until safety, performance and quality standards have been met. Description and information related to the device are registered and company manufacturing process is being checked and approved.

Purpose

Register medical devices centrally among GCC countries.
Harmonizing classification rules for medical devices between GCC countries.
Harmonizing regulations and procedures of medical device registration.
Enhancing the cooperation between GCC countries in medical device field.
Following the international standards in site inspection.
Establish a new harmonized electronic system that will enhance the registration process by making it more efficient and effective.

Medical device bylaws

Medical device registration bylaws is a document that represents the framework of the registration process and the guidelines and procedures conducted within the medical device department.

Medical Device Registration Committee

Competent members of the committee assess medical devices in an unbiased – internationally – harmonized manner. They register medical devices based on their safety, quality, and performance. As well as that, continuously update medical device bylaws as per any international change or modifications.

Study company dossier and register medical devices accordingly.
Study companies’ requests for making scientific modifications on their medical products.
Continuously develop medical devices bylaws by adapting to the global changes and new technology innovations.
Post-market vigilance on the marketed registered items to assure safety and quality control.

Gulf Committee for pricing pharmaceuticals

This is the committee that has been approved for the pricing of pharmaceutical products of the GCC countries as follows:

Committee members:

Two members from each GCC country.
The Chairmanship of the committee is carried out by one of the member states, alternating each year according to the Health Council meetings system.

Unifying the pricing of new medicines

Activate and improve the adoption of digital connectivity among GCC countries to speed up access to information

Ensuring that all GCC agent and pharmacy profits do not exceed 45%

Standardization of the prices of locally and nationally registered medicines when re-registering, which must happen every five years

Studying and responding to pricing objections raised by pharmaceutical companies in instances such as the transfer of ownership, place of manufacture or marketing costs.

Standardization of pricing systems and procedures across the GCC.

Studying any issues submitted to the Committee by GCC countries regarding the pricing of pharmaceuticals and health products containing vitamins.

Developing pricing and re-pricing rules for pharmaceuticals before submitting them for approval.

Central Registration Official Website

drug.registration@ghc.sa

md.registration@ghc.sa

About Central Registration

Central Drug Registration