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A Certificate of Pharmaceutical Product (CPP) is an official document issued by a national regulatory authority to confirm the regulatory and manufacturing status of a pharmaceutical product in the exporting country. It is the primary document within the World Health Organization’s Certification Scheme on the quality of pharmaceutical products moving in international commerce. The scheme is voluntary and is intended to provide assurance to participating countries about pharmaceutical products moving across borders.
What Is the Purpose of a CPP?
The CPP is used to communicate verified regulatory information from the certifying authority to an importing authority. Depending on the issuing authority and the product context, it may confirm elements such as the product’s authorization status, the responsible regulatory authority, the manufacturer’s licensing status, and information relevant to quality, safety, and efficacy assessment. WHO also notes that model certificates are consistent in principle, although format and wording may vary by issuing authority.
How Is CPP Used Across Regulatory Systems?
Although the CPP follows a globally recognized WHO framework, its role is not harmonized worldwide. Countries may request it at different stages of the regulatory process, interpret it differently, or accept different supporting formats depending on their own legal and regulatory framework. WHO explicitly states that certificates issued by different national authorities may vary in format and wording, and that specific information should ultimately be confirmed with the exporting country’s authority.
In practice, the CPP is often used in connection with international submissions, export-related processes, or assessments in markets that require prior approvals from other authorities. EMA, for example, presents certification of medicinal products as part of its post-authorisation framework, while FDA issues electronic CPPs for certain human drug exports and provides them directly through its export certification system.
Why Is CPP Important in Regulatory Submissions?
The CPP plays a practical role in supporting regulatory submissions when an authority needs verified information about a product’s regulatory standing in another jurisdiction. It can help reduce uncertainty during review by providing an official regulatory reference point, particularly in markets that rely on prior approvals from reference authorities or request export certification as part of their review logic.
That said, the CPP should not be treated as a universal or uniformly applied requirement. Its importance depends on the receiving authority’s expectations, the type of product, and the specific regulatory pathway involved. For that reason, companies should evaluate CPP needs country by country rather than assuming a single global rule.
Key Considerations for Pharmaceutical Companies
When planning submissions that may involve a CPP, companies should assess whether the target market requests it, when it is expected in the process, whether electronic versions are accepted, and how it fits with other supporting documents. WHO has also acknowledged the use of secure electronic signatures under the certification scheme, and both WHO and major authorities, such as FDA and EMA, have reflected this shift toward electronic certification practices.
A practical way to approach the CPP is to treat it as part of broader submission planning rather than as a standalone administrative formality. Used correctly, it can support regulatory communication and facilitate market access discussions across jurisdictions, but its relevance always depends on the receiving market’s specific framework.