Approaches to include drug substance quality information in a drug product application (June 2022)

The end goal of Drug Product (DP) development is to receive approval for the DP by one or multiple Health Authorities. This enables the company to bring the DP to the market. Collecting all quality, safety and efficacy information required for the application is usually quite complex.

This whitepaper aims to support you with deciding on the optimal approach for providing the required drug substance (DS) quality information to Health Authority(ies). To understand the pros and cons of the following three most commonly used approaches, detailed information is provided in a questions and answers format.

The approache are:

1. Referring to a Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)
2. Referring to a Drug Master File (DMF)
3. Adding the quality information about the DS in the DP application dossier