Register Central
It is a unified system for registering medical products (human medicines – medical devices – veterinary medicines) in the GCC Health Council, to ensure the quality, effectiveness and safety of the medical product, and the accuracy of information related to it, and that it is manufactured in accordance with international specifications and standards. It is considered one of the most important goals that the central Gulf committees seek to register medical products to achieve are:
Unifying systems and procedures related to the process of registering medical companies and their products in the GCC countries. It also aims to ensure the application of the principles of good manufacturing of medical products, standardize the pricing of drugs marketed in the GCC countries, activate the post-marketing follow-up program for medical products related to quality and side effects of products, which increases integration. And coordination among member states in the field of medical products. The Gulf Products Classification Committee also carries out the classification process based on unified definitions and standards.
Central drug registry goals
It is a unified system for drug registration in the GCC Health Council, to ensure the quality, effectiveness and safety of the drug, and the accuracy of information related to it, and that it is manufactured in accordance with international specifications and standards. This system aims to:
Unifying the pricing of medicines that are marketed in the GCC countries
Unifying the registration of pharmaceutical companies in the GCC countries
Standardization of systems and procedures in the process of registering pharmaceutical companies and medicines
Increasing integration and coordination among member states in the pharmaceutical field
Standardization of information and conditions when registering medicines
Ensuring the application of the principles of good manufacturing by companies
Access to safe and effective medicine at reasonable prices
Using the drug optimally and at the lowest cost
Follow-up of medicines in terms of quality and side effects
Central Gulf Committee for Drug Registration
It is the committee that was approved to carry out the central drug registration for the countries of the Cooperation Council according to Resolution No. (6) at the forty-fifth conference, which was held in Geneva (Switzerland) in May 1998.
Committee members
Two members from each country
Chairmanship of the Committee
The committee is chaired by one of the member states, and it rotates every year according to the Health Council meetings system
Committee meetings
The committee holds (12) meetings, including (6) meetings that take place via conference call between technicians in the countries to study the registration files in the member states.
The tasks of the committee Central Drug Registry
Approval of pharmaceutical preparation analysis reports issued by accredited reference laboratories in the Member States.
Inspection in the factories of pharmaceutical companies to ensure that the principles of good manufacturing of medicines are applied.
Studying technical reports received from Member States or international bodies on pharmaceutical companies and their preparations and taking the necessary actions in this regard.
Registration of drug and pharmaceutical companies according to the unified registration regulations
Medical Devices and Supplies Registration Committee
It is the committee that works to register medical devices and supplies in accordance with international standards. The committee verifies the safety, effectiveness and efficiency of medical devices.
The committee was formed by a decision of the Ministers in the forty-second session of the Council of Ministers of Health by circulation
The members of the committee study all files related to medical devices and companies’ requests in accordance with the scientific and international foundations in registration. They also constantly develop the registration process according to international amendments and developments in this context. The committee meets six times a year
Registration of medical devices and supplies
- Central registration of medical devices and supplies at the level of the GCC countries
- Unifying the classification of medical devices and supplies among the GCC countries
- Establishing a unified electronic system for registering companies of medical devices and supplies in the GCC countries
- Standardization of systems and procedures in the company registration process
- Integration and coordination among member states in the medical field
- Standardization of information and conditions when registering medical devices and supplies
- Ensure that international standards are followed in the inspection of factories
Gulf Committee for Pricing of Pharmaceuticals
It is the committee that was approved to do the pricing of pharmaceutical preparations for the GCC countries, according to the following:
Committee members
Two members from each country. The committee is chaired by one of the member states, alternately every year, according to the Health Council meetings system
Committee meetings
The Committee meets regularly throughout the year, approximately every three months, in one of the GCC countries, alternately
Duties of the Gulf Committee for Pricing of Pharmaceuticals
Repricing
Objection handling
Classification of medical and health products
Establishing a unified electronic system for product classification in the GCC countries
Standardization of definitions and criteria for classification of products
Classification of products centrally at the level of the Gulf Cooperation Council countries