Caribbean Countries Consider Creating Generic Drug Registry

Countries in the Caribbean are working to establish a unified registration process for generic drugs, an effort aimed to improve the quality, availability and access to essential therapies.

A centralized registry would reduce duplication of efforts and include measures to support training of technical personnel and improve post-marketing surveillance of products, according to regional authorities coordinating the project, including the Pan American Health Organization (PAHO), the World Health Organization, the Caribbean Community and the Caribbean Public Health Agency.

The groups, which met last month in Jamaica, agreed on high-level principles for such a system and will continue their discussions in the coming months, Maria Luz Pombo, biological products specialist at PAHO, said.

The registration system would focus initially on the WHO list of essential medicines, in particular on the registration of generics to treat non-communicable diseases, as well as some priority antibiotics. Decisions on whether to include specific products would depend on registration and marketing authorization status in third-party reference countries.

Access to safe and effective medicines continues to be a challenge as some countries in the region face significant obstacles in regulating medicines. In 2011 and 2012, for example, only 44 percent of Caribbean countries reported even having a national medicines registration process, according to PAHO.

“A unified registration process will make it possible for all Caribbean Community countries to improve access to quality essential medicines and thus benefit the 16.7 million people who live in this subregion,” said James Fitzgerald, director of health systems and services at PAHO. — Jonathon Shacat

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.