PP09-61: CPP Requirements for the Registration of Medicines in the Region of the Americas
Cammilla Horta Gomes
Latam Regulatory Policy Lead
To present results of 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” - developed in the framework of the Pan-American Network for Drug Regulatory Harmonization.
The study was prepared in 2019-2020 with data collected in 2018 via a survey prepared by the Cuban regulator CECMED and the regional industry association FIFARMA. It includes 27 countries of the Americas, with the participation of 23 Regulatory Authorities and 14 representatives of industry.
The study collected data about the requirements and practices related to the use of the CPP for submission of new drug applications, submission of renewal applications submission of post-approval changes / variations. It also inquired about the format of CPP that is accepted and issued by different regulatory authorities and the information evaluated in the CPP. Results indicate, among others, the following trends* for the CPP in the Americas:
- required for all new drug applications;
- not required to be issued by a regulatory authority considered of reference by the receiving country;
- may come from a country where the product is registered even if not manufactured in the territory of this country;
- is accepted even if the issuing country has recognized the GMP status of the manufacturer from another regulator;
- may be substituted by other documents under specific conditions;
- does not mean that the regulator will expedite the assessment of a dossier;
- required for renewal of registration under the same conditions as for a new drug application;
- regulators assess the information presented in the document and this evaluation impacts decision-making;
- GMP status of the manufacturer is recognized;
- it is mandatory to inform when there is a change in the status of registration of the product in the country that issued the CPP;
- legalization (or apostille) is required;
- there is a term of validity for the acceptance of the CPP;
- may not be required by a company that is not the market authorization holder (or their legal representative);
- requirements in the CPP do not change depending on the type of product;
- regulators that issue CPP do that in an specific time frame, and documents issued have an expiration date.
* For the purposes of this abstract, trends occur when a requirement or practice is observed for least for 60% of the countries surveyed.
The study shows that CPP is a document widely required by countries in the Americas. For many regulators, the CPP is a mandatory document for new marketing applications and several other applications related to the drug’s life cycle. The CPP required by regulators in the Americas is a document that contains summarized information of the regulatory status of an imported medicine, including information about the manufacturer and, the commercialization status of the product in the territory where the CPP was issued.
The WHO template for the CPP is apparently widely accepted by regulators of the Americas. Nevertheless, the study showed that, 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 adequate to the new global regulatory environment and the current characteristics of the pharmaceutical market.
In this context, the results of the study can support the ongoing discussion sponsored by WHO in the revision of the Certification Scheme on the quality of pharmaceutical products moving in international commerce. In addition, an expected outcome of the study is to contribute to regional debates for the identification of alternatives and best practices related to the CPP in the region of the Americas, informing future recommendations that might emerge from the PANDRH Conference to regulators in the region.