EMA: Changes to Handling of Variations

Recommendation

6/7 September 2022

Drug Master File Procedures in the EU, the US and Japan - Live Online Training
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

Because of the ongoing reorganisation of the European Medicines Agency (EMA), new operating procedures will apply for:

• Type IA and IB variations;
• Type II variations;
• Periodic Safety Update Reports (PSURs);
• Administrative procedures such as transfers, 61(3) notifications and corrigenda.

The overall processes remain unchanged, but new contact persons will be assigned. Applicants will be informed directly when their contact person will change.

What is the reason for this?

As part of the new operating model, EMA is revising the existing product team lead concept and replacing it with two new roles:

Procedure Manager
Oversees all aspects of the management of specific procedures. They are responsible for managing the regulatory process surrounding each application and provide guidance on regulatory procedural matters. Procedure Managers will be the primary contact point for applicants and experts from the national competent authorities.

EMA Product Lead (EPL)
Maintains oversight of a medicine throughout the different stages of its lifecycle. They are responsible for the overall knowledge about a medicine providing regulatory science input to EMA's scientific committees when needed.

Source: EMA press release