International Cooperation and Harmonization
Harmonization of technical requirements for medicines regulation, i.e., legislations, technical guidelines, procedures, etc., is a basis for successful collaboration in the area of medicines regulation. In implementing of the medicines regulation, it should be noted that this could not be effective if all major aspects of regulation are not addressed.
Harmonization of technical requirements for medicines regulation is a desirable goal for many reasons:
- Companies have to generate only one data set for all regions, and consequently the amount of human and animal experimentation is reduced.
- The cost of development of regulatory documentation both for new drugs and multisource/generic medicines is reduced, which can lead to lower prices.
- Common regulatory standards for scientific evaluation and inspection facilitate regulatory communication and information sharing.
- Local products are more likely to be acceptable for export to other countries.
- Faster access to medicines of high public health value (paediatric medicines, medicines for major diseases or for emergencies in national settings etc.).
- Increased competitiveness resulting from newly developed common markets.
Promoting medicines regulatory cooperation and harmonization in Africa
African Medicines Regulatory Harmonization Initiative (AMRHI) was established in 2009 with the intention to improve health in the African Region by increasing access to safe and effective medicines of good quality. This can be accomplished by strengthening the technical and administrative capacity of participating national medicines regulatory authorities. AMRHI restricts its focus to medicines registration and specifically to the registration of priority essential medicines (mostly generic pharmaceuticals) in order to maximize near-term patient benefit and impact the critical disease burden facing Africa.
Collaborative mechanisms for medicines regulatory systems and processes at the regional/sub-regional levels should translate into improved regulatory approval processes and operational efficiencies at the national level. In this regard, the project aims to increase the capacity of national medicines regulatory authorities and specifically strengthen the administrative, structural and technical elements of medicines regulation. In doing so, the project will help countries to enhance and facilitate their decision making processes regarding the registration of medicines, as well as exercise more control over medicines circulating on the market. Regulatory capacity building and facilitation of information exchange are thus indispensable components of the project.
Specifically, the project objectives include:
- To create a collaborative network through partnership between medicines regulatory authorities of participating countries and/or selected sub-regional economic blocks.
- To harmonize technical requirements for the regulation of medical products and build confidence so that agreed harmonized standards are implemented and respected by participating authorities.
- To establish a framework for joint evaluations of application dossiers and inspections of medicine manufacturing sites.
- To strengthen the capacity for regulatory oversight.
In the framework on the of the African Medicines Registration Harmonization Initiative, WHO Medicines Regulatory Support Programme has organized and technically supported several regional preparatory activities in initiating harmonization.
CTD Implementation Workshop for Francophone countries of Sub-Saharan Africa, Douala, Cameroon, 28-30 June 2010
CTD Implementation Workshop for Anglophone countries of Sub-Saharan Africa, Dar es Salaam, United Republic of Tanzania, 9 - 11 November 2010
Joint GMP Inspection exercise, Douala, Cameroon, 21-26 February 2011