EMA has revised guideline on drug product manufacturing information to include in CTD module 3

The Committee for Human Medicinal Product (CHMP) recently adopted an updated guideline on manufacture of the finished dosage form.

The document, which will come into effect on 14 February 2018, provides clarification on the type and level of information to include in the CTD module 3 of a Marketing Authorisation Application (MAA) dossier with respect to the manufacturing process description. It applies to initial applications and variations affecting the manufacturing process.

The guideline replaces the note for guidance published in 1996, which has been updated to reflect the current regulatory requirements and dossier format. It also addresses current manufacturing practice involving complex supply chain or storage and transport of intermediate products.

This guideline can be accessed by clicking here.