As the PANDRH CPP Project reaches a milestone, FIFARMA recognizes CECMED’s Director Dr Pérez Cristiá for his role in this successful initiative.
The PANDRH Network is an initiative of National Regulatory Authorities (NRAs) in the Region of the Americas and regional industry associations, including FIFARMA. The technical work of the PANDRH Network supports regulatory convergence through the development of projects in the areas identified as priorities by the Network.
The project “Assessing CPP requirements for drug registration processes in the Region of the Americas towards more timely access to medicines and more convergent regulatory approaches” was the first PANDRH project approved to be jointly conducted by a NRA – CECMED, Cuba – and a pharmaceutical industry association.
The project’s Work Plan includes, as a first step, the development of a comprehensive mapping of how PANDRH members regulate CPP-related requirements. A survey was prepared to collect data, from regulators and industry, about the requirements and practices related to the use of the CPP. It also inquired about the format of CPP that is accepted and issued by different regulatory authorities, and the information evaluated in the CPP.
Some preliminary results of this study activity were presented during the 2020 DIA Global Conference, held virtually past June. A poster was prepared with a summary of part of the information that the CPP project was able to collect, including information for 27 countries of the Americas. A publication with complete information about the project’s findings is expected for the upcoming months.
With this publication, PANDRH hopes to contribute to the ongoing international discussions sponsored by the World Health Organization (WHO) for the revision of the Certification Scheme on the quality of pharmaceutical products moving in international commerce. Also, the results might support in the identification of trends and best practices related to the CPP, informing future recommendations for the Americas that might be adopted by PANDRH Conferences.
Partnership with CECMED
The development of the CPP Project in PANDRH, initially proposed by FIFARMA, was promptly sponsored by CECMED. Since the beginning, the work and dedication of the Cuban NRA to the Project have been instrumental for the results achieved so far. This level of engagement was only possible because of the endorsement and outstanding collaboration offered by CECMED’s former Director, Dr Rafael Pérez Cristiá.
FIFARMA joins the regulatory community in recognizing the value of Dr Pérez Cristiá’s contribution to global health, actively advancing regulatory strengthening and promoting regional cooperation among NRAs. FIFARMA and its members send their warmest regards to Dr Pérez Cristiá’s family and CECMED staff for their loss.
If you are interested in knowing more about the CPP Project, please check the PANDRH Project description and the short 2019 article “CPP Requirements for Medicines Registration in the Region of the Americas”.
FIFARMA also recommends reading the recently published article “Use of the Certificate for Pharmaceutical Products (CPP) in 18 Maturing Pharmaceutical Markets: Comparing Agency Guidelines with Company Practice”, by the Centre for Innovation in Regulatory Science (CIRS).