Assessing the certificate of pharmaceutical product (CPP) requirements for the drug registration processes in the region of the americas, towards a more timely access to medicines and more convergent regulatory approaches

This document presents a summary of the analysis of the results for the assessment of the requirements and practices for the acceptance, use and issuance of the Certificate of Pharmaceutical Product (CPP) as a key document in the regulatory processes of medicine registration in the region of the Americas, and in the legal basis supporting its use. The aim is to summarize the impact of the CPP in the registration of the pharmaceutical products in the region in order to identify convergences and divergences, to generate points of consensus and to promote good practices and actions that allow for mitigating the time gaps in the availability of the medicines between the countries of the regions and those which are more technologically developed.