Workshop on the Scientific Assessment of Registration dossiers of Prequalified Medicines and WHO Collaborative Registration Procedure

Workshop on the Scientific Assessment of Registration dossiers of Prequalified Medicines and WHO Collaborative Registration Procedure

Since 2001, the World Health Organization (WHO) has been conducting the prequalification of medicines to ensure the safety, efficacy, and quality of drug products addressing certain diseases such as Malaria, HIV/AIDS, and Tuberculosis. To date, a number of these products are already available to patients especially from developing countries where access to quality medicines and healthcare is limited. However, with the emergence of certain issues such as new technologies on medicines, difference in the capacity of National Regulatory Authorities (NRAs), and demands and expectations from the stakeholders, availability of safe, effective, and good quality medicines are compromised. To address these concerns, the WHO has formulated the Collaborative Registration Procedure (CRP) facilitating the national registration of products that are previously assessed and prequalified. On 08 October 2015, the Food and Drug Administration has been listed as one of the NRAs participating in the CRP.

The workshop was held on 12-15 October 2015 at Amari Watergate Hotel, Bangkok, Thailand. At the start of the training, representatives from each NRA shared the process of drug product registration in their respective countries as well as the challenges encountered. Members of the WHO Prequalification Team (PQT) served as resource speakers in this workshop. They discussed on Assessment of the Quality of Active Pharmaceutical Ingredient (API) and Finished Pharmaceutical Product (FPP), and Bioequivalence. Group exercises were conducted applying the guidelines and principles of API and FPP dossier evaluation and composition of a good assessment report. The concept of CRP was also discussed, including the process of participation of NRAs and application for registration of prequalified medicines in the participating country, and the future plans of each NRA in relation to the CRP. This four-day activity was attended by the regulators from Cambodia, Indonesia, Lao PDR, Myanmar, Philippines, and Thailand. Mr. Willison John E. De Luna, a technical officer from the Licensing and Registration Division, Center for Drug Regulation and Research, represented the Food and Drug Administration.

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