New EMA Guideline on the Manufacture of the finished Dosage Form

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

Although the title draft Guideline on Manufacture of the finished Dosage Form might indicate that the content of this new guideline relates to manufacturing of investigational medicinal products and/ or marketed products, it does not introduce new GMP requirements. The guideline applies to the description of the manufacturing method in the application, namely in the CTD Module 3 of the marketing authorisation dossier. This guideline should be read in conjunction with Directive 2001/83/EC Article 8.3 (d) (ref 2) where it is stated that the application for a marketing authorisation shall contain a description of the manufacturing method. The requirements on the description of the manufacturing method are described in Annex 1of the directive and are further elaborated in this new guideline.

The guideline replaces the Note for Guidance on the Manufacture of the finished Dosage Form (CPMP/QWP/486/95) with the aim to:

• reflect changes to the format and content of the Common Technical Document (CTD) Module 3 dossier
• address current manufacturing practices in terms of complex supply chains and worldwide manufacture
• take into account principles of the ICH Q8 guideline

and - as a result - provide clarification on the type and level of information that should be included in the CTD Module 3 of the marketing authorisation application (MAA) dossier with respect to the manufacturing process description. The headings of the guideline follow the structure of the CTD format Module 3, Section 3.2.P.3 Manufacture. Only product specific aspects of manufacture need to be described and included in the MA-dossier; general elements of Good Manufacturing Practice (GMP) should not be included.