CPP Requirements for Medicines Registration in the Region of the Americas

PANDRH’s CPP project

Jaime Oliveira
Head of Regulatory Policy and Intelligence LatAm,
Bayer S/A

Celeste Sánchez
Head of Editorial Committee,
Cuban Journal of Pharmacy,
Head of Policies and Regulatory Affairs, CECMED


he Certificate of Pharmaceutical Product (CPP) is the primary document of the World Health Organization’s (WHO) Certification Scheme on the quality of pharmaceutical products moving in international commerce.

The Certification Scheme is an international voluntary agreement originally developed in the late 1960s with the objective of providing assurance to its members about the quality of the pharmaceutical products moving in international trade. The CPP contains summarized information of the regulatory status of the medicine, of its manufacturer in the CPP’s issuing country and, according to the WHO’s model, the commercialization status of the product in the territory of the CPP’s issuing country.

The CPP is widely required by emerging countries in new drugs’ submission processes, post-approval changes and renewal of drugs’ registrations. In many Latin American countries, the CPP is a mandatory document for new marketing applications and several other applications related to the drug’s life cycle.

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. Differences have been identified in the Region with respect to the regulatory authorities whose CPPs are accepted, the required information contained in the CPP template, the applications where the CPP is required and when such a document must be submitted. In several cases the CPP is a pre-requisite for submissions of, or decisions on, drug applications and in such situations marketing authorizations in the Region cannot be obtained until the drug or its variation is approved by an accepted regulatory authority.

CPP-related regulations and procedures have been discussed in view of the new global regulatory environment and the current characteristics of the pharmaceutical market. In this context, the WHO Expert Committee on Specifications for Pharmaceutical Preparations, during its 43rd meeting, recommended that the WHO Certification Scheme should be reviewed “in light of the changing environment, including the rapid globalization of the pharmaceutical manufacturing sector coupled with changes in the make-up of both the regulators and the groups involved in procurement.” This position has been reinforced with the adoption by this Committee of the revised document of questions and answers about the Scheme in October 2015, as an opportunity to advocate for active support of the effective functioning of this quality tool.

To assess this complex scenario as it relates to American countries and promote a discussion on the opportunities to update and improve CPP-related regulations and practices in the Region, the Steering Committee of the Pan-American Network for Drug Regulatory Harmonization of the Pan-American Health Organization (PANDRH/PAHO) approved in December of 2017 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”, which is being coordinated by the Cuban regulatory authority (Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos – CECMED) and the Latin American Federation of the Pharmaceutical Industry – FIFARMA.

The CPP project is the first PANDRH project that will be conducted jointly by a National Regulatory Authority (NRA) and a pharmaceutical industry’s association. The project’s Work Plan comprises the development of a comprehensive mapping of how PANDRH members regulate CPP-related requirements and a structured discussion among National Regulatory Authorities, the pharmaceutical industry and, occasionally, other stakeholders with appropriate expertise, on the current public health role of such requirements and their adequacy to meet the evolving needs of patients, regulators and the industry. Expected outcomes are intended to facilitate the identification of opportunities to improve the convergence and updating of CPP regulation in the area, optimizing NRA’s good regulatory practices and performance. Ultimately, the project’s aims are to provide a contribution to faster patient access to new health technologies.

The CPP project’s final report is expected to be submitted to PANDRH’s Steering Committee in March 2019. Interested parties may follow the project, consult relevant documentation and know the CPP project’s agenda by registering at PAHO’s Regional Platform on Access and Innovation for Health Technologies (PRAIS) and joining PANDRH’s CPP project Community of Practice.