Certificate of Pharmaceutical Product (CPP) and eCPP
- CPP Network Training Toolkit
- CPP training toolkit overview
- IFPMA position on the use of CPP
- IFPMA position on the use of eCPP
- Frequently asked questions on US CPP
- Webinar on eCPP
The Certificate of Pharmaceutical Product (CPP) is a document issued by a country’s regulatory authority at the request of a product owner to support the registration process of a pharmaceutical product of another regulatory authority in a different country.
The certificate has been introduced as a tool to accelerate the availability of new medicines, especially in countries that do not have the infrastructure or capabilities to complete a full quality, safety and efficacy (QSE) review themselves, by summarizing essential data such as the quality, safety, and efficacy of the pharmaceutical product. It therefore helps reduce the time to market of products through reliance on a prior trusted analysis, and eliminates duplicative evaluations.
The CPP confirms:
- the approval from the referenced national regulatory authority was based on a full evaluation of the product’s quality, safety and efficacy;
- the product is manufactured under good manufacturing practices; and/or
- the registration and marketing status of the product in the certifying country
The WHO Certification Scheme, implemented in 1997, lays down the framework for regulating these certificates. The CPP has become one of the most essential reliance documents in the registration of medicinal products in over 80 countries.
In many countries, the CPP is a mandatory component of the regulatory dossier as it summarizes all relevant data regarding the pharmaceutical product. It is required for new product submissions, certain variations, renewals and tenders.
Despite the original aim of the WHO Scheme since 1997, i.e. to provide a standard process, the regulatory procedures among countries have varied significantly and different approaches and interpretations of the CPP Scheme have applied from one country to another.
Electronic Certificate of Pharmaceutical Product (eCPP)
With the increasing number of CPPs required for regulatory submissions generating an administrative burden for both regulators and industry, and with the evolution of digital technologies, IFPMA encourages the issuing and acceptance of electronic CPPs (eCPPs).
The use of eCPP will:
- Increase collaboration & trust amongst regulators
- Increase security of documents and decrease the opportunity for falsification
- Opportunity to modernize and harmonize administrative content
- Facilitate acceleration of submissions contributing to faster access of medicinal products
- Enable regulatory compliance and sustainable supply
- Simplify processing CPPs globally
The eCPP should be fully integrated with other digital systems used for dossier submission and review, including e-signatures and electronic dossier submissions. Appropriate international security standards for electronic signatures should be in place to ensure the authenticity of digital documents, including eCPP. This would made additional legalization of the eCPP redundant.
Rapid adaptation and use of available digital technologies by the regulators during the COVID-19 pandemic provided opportunities to modernize the regulatory ecosystem. Data collected by IFPMA and EFPIA in May 2020 from 80 countries demonstrated that almost 90% of countries’ NRAs have accepted eCPPs to facilitate lifecycle management submissions of products on the market or new product approvals. According to experts, the practice of accepting eCPP should be maintained.
To help provide an explanation on the current framework on CPPs, and provide input as required in the modernization of the framework, IFPMA has created a training toolkit and position papers.