CPP Requirements for Medicines Registration in the Region of the Americas. PANDRH’s CPP project.

The Pan-American Network for Drug Regulatory Harmonization’s (PANDRH) Steering Committee approved in December 2017 the project “Assessing the Certificate of Pharmaceutical Product (CPP) requirements for drug registration processes in the Region of the Americas towards more timely access to medicines and more convergent regulatory approaches“. The project is the first PANDRH’s initiative coordinated jointly by a National Regulatory Authority, CECMED/Cuba, and a regional pharmaceutical industry association, FIFARMA.

The execution of the project began in February 2018. In its first phase, an exhaustive mapping of the requirements and practices related to CPP in the region of the Americas will be developed. The resulting diagnosis aims at creating the base for a second phase, which has the objective of developing a structured discussion to identify opportunities for improvements in CPP regulatory requirements in the region.

The rollout of PADNRH’s CPP project coincides with the launching of the “Proposal for the revision of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce”, which will receive comments until May 15 and that can be found at:

The May Issue of the Drug Information Association’s  (DIA) digital magazine, the DIA Global Forum, which offers expert global and regional coverage of the discovery, development, regulation, surveillance, and marketing of healthcare products, including interviews with thought leaders and topical summaries from educational events, features an article on the CPP project co-authored by the project’s focal points in CECMED, Dra. Celeste Sánchez, and in FIFARMA, Jaime Oliveira. The article can be assessed here

We hope you enjoy the reading and join the CPP project’s community at PAHO’s platform PRAIS

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