- Palabras clave > drug registration
- Palabras clave > legal framework
- Palabras clave > marketing authorization
- Palabras clave > medicines registration
- Palabras clave > medicines registration systems
- Palabras clave > medicines regulatory systems
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > registration of medicinal products
- Palabras clave > registration of pharmaceuticals
- Palabras clave > situation analysis
(2016; 22 pages)
Kim, EunMi. 2016. Situation Analysis: Introducing Pharmaceutical Product Registration Policy in Angola. 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 DNME of the MINSA recognizes the importance of regulating pharmaceutical products and wants to introduce a new policy to mandate product registration to better control the safety, quality, and efficacy of pharmaceutical products. The National Department of Medicine and Health Products of the DNME is the responsible unit for managing pharmaceutical product registration. However, the unit has been challenged by a lack of staff and budget when preparing to implement this new policy.
The DNME has been preparing to implement a new policy that will switch from importer-based regulations to product-based regulations. However, has been challenging to build a comprehensive database on the importation and distribution of pharmaceutical products that could be used to understand the quantities and types of medicines that need to be registered.
In 2012, the US Agency for International Development-funded SIAPS Program conducted a comprehensive assessment of the current regulatory system in Angola and the DNME’s capacity to strengthen that system. As a follow-up, in April 2015 and 2016, SIAPS was invited by the DNME to provide technical assistance to prepare a new policy that would mandate product registration by assessing the current situation and developing implementation strategies for the new policy.