- Palabras clave > automated data
- Palabras clave > drug registration
- Palabras clave > harmonization - medicines registration
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > medicines registration systems
- Palabras clave > pharmadex - computerized assisted drug registration
- Palabras clave > registration dossier
- Palabras clave > registration of pharmaceuticals
- Palabras clave > Standards Operating Procedures (SOP)
(2016; 24 pages)
Maïga D, Evi B, Gbaguidi A. 2016. Rapid Evaluation of the Medicines Registration System in Benin. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health.
The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to strengthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system.
In light of these elements, the director of DPMED wishes to adopt suitable software to strengthen the registration system for medicines and other health products. Although computerization yields improvements in the management of regulatory information, its effectiveness will largely depend on the presence of adequate medicines registration procedures and the system’s overall compliance with regional and international standards.
This rapid evaluation thus seeks to analyze and understand Benin’s regulatory information management system for medicines registration, make appropriate recommendations, and propose an action plan based on emerging outcomes.
This evaluation analyzes Benin’s medicines licensing and marketing systems, and further identifies mechanisms to improve DPMED’s management of regulatory information.
The specific objectives of this evaluation are to:
- Carry out a rapid analysis of the regulatory information management system emphasizing the medicines registration process
- Draft recommendations and propose an action plan in consultation with the DPMED to improve the medicines registration management information system