- Palabras clave > drug regulatory authorities
- Palabras clave > harmonization of medicines regulation
- Palabras clave > medicines regulation
- Palabras clave > medicines regulatory systems
- Palabras clave > National Medicines Regulatory Authority (NMRA)
- Palabras clave > pharmaceutical regulation
- Palabras clave > regulatory institutional capacity
- Palabras clave > regulatory systems
(2006; 34 pages)
On September 2004 national responsible professionals for national programs met to review and analyze the ACP project plan of work of the first year. That meeting took place in Barbados and as a result participants prioritize activities of the ACP project. Drug Regulation was identified to be a third priority to address, being the first two: drug access and drug supply. At the same time, CARICOM Secretariat informed at that meeting that they would be implemented a sub-regional study on Drug regulation and on implementing TRIPS legislation as separate study. At that meeting it was agreed that since CARICOM will implement such studies, the best decision to take was not to overlap and to focus ACP activities on other regulatory activities, as well as other areas of the ACP project.
The second phase of the ACP project was recently approved and the Expected Result # 6 refers to Effective Drug Regulation in the Region, being strengthening medicine registration in the Caribbean an important part of that component.
In order to review the current status of the registration process and activities carried out in the Caribbean region, PAHO/WHO organized this meeting.
It is recognized worldwide that National registration of pharmaceuticals is a primary responsibility for every country and a main public health issue of the MOH. Leadership of MOH in the public arena includes drug regulation and access to quality drugs and as National Regulatory Authority must perform several functions to respond to an effective drug regulatory system. Moreover, an effective system for drug regulation can be cumbersome and difficult in terms of availability of human resources, and technology and extremely expensive. This is more evident in countries with smaller size of their national pharmaceutical market. The need to explore different modalities to address drug regulation that have been successful in other countries or regions cannot be avoided when analyzing the case of the Caribbean region.