P68: The Use of CPP for Drug Registration Processes in Twenty Five Countries in the Americas: Requirements and Areas of Opportunity
Cammilla Horta Gomes
Latam Regulatory Policy Lead
To identify trends and opportunities for more convergent regulatory approaches in the use of the Certificate of Pharmaceutical Product (CPP) by 25 regulators in the Americas.
The initial study was published in 2020 with data collected in 2018, via survey, from regulators and industry. It includes 25 countries of the Americas that require the CPP. The trends were compared to international best practices as recommended by WHO to identify potential areas for improvement.
The study allowed detailed understanding of the CPP use for registration, renewal and post-approval changes. It showed that all regulators conduct an evaluation of the CPP, including the market authorization status of the product as declared in the CPP. It characterized the impact of the cancellation or suspension of the registration by the regulator that issued the CPP in the country that receives the CPP. It indicated that there are no specific requirements from regulators regarding the commercialization status of the product in the issuing country. The study also enabled the collection of other important information, including the lack of training of regulators about the WHO CPP Scheme, the fact that most still require legalization and translation of the document, the low acceptance of electronic CPPs, the fact that the CPP is given an expiration date. The areas of opportunity for improvement that were evaluated include: implement higher degree of flexibility in regulations; use of the CPP to enable reliance and expedited submissions; need for more periodic review of the regulatory framework to be up-to-date with international practices and recommendations; a more aligned understanding for the concept of “country of origin”; greater convergence of regulatory requirements and standards; waive legalization requirements; greater understanding and support from government for regulatory modernization; use of the WHO recommended model for the CPP.
The study showed that CPP is a document widely required by countries in the Americas. Despite its origin in a WHO international agreement, there is a significant diversity of CPP-related regulatory models and practices in the Latin American region. There is a need not only to encourage convergence of practices to enable rationalization of regulatory process and timely access to medicines in the region of the Americas, but also to promote CPP-related regulations and procedures that are aligned with the new global regulatory environment and the current characteristics of the pharmaceutical market.