EMA: Draft Guidance for Centralised Procedures open for Comments

Recommendation

6/7 September 2023
Vienna, Austria

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

In December 2021, the European Medicines Agency (EMA) published the draft of the "Guideline on the acceptability of names for human medicinal products processed through the centralised procedure" for public comment on their website.

The current 7th revision of the document shows, in addition to the two new appendices (Appendix 1+2), mainly changes and innovations in chapter 6 "EMA procedure for checking proposed (invented) names". Newly added are the following paragraphs and subparagraphs:

• 6.6. Conditional acceptability and bilateral negotiations 
• 6.8. Maintenance of (invented) names
  - 6.8.1. Withdrawal of an accepted (invented) name
  - 6.8.2. Expiry of an accepted (invented) name 
• 6.9. Re-use and reconfirmation of (invented) names
  - 6.9.1. Re-use
  - 6.9.2. Reconfirmation

It also contains revisions to Chapter 4, "Criteria applied when reviewing the acceptability of proposed (invented) names", which largely relate to paragraphs 4.1. and 4.2.

Paragraph 4.1 "Addressing safety concerns and other public health concerns in proposed (invented) names" has been fundamentally revised to show the additional subparagraphs 4.1.11 - 4.1.18.

The following paragraph 4.2 "Addressing international non-proprietary names' concerns in proposed (invented) names" has also been restructured and supplemented, for example with parts of the data of the former sub-paragraph 4.3.6.

The public consultation on the regulation is open until mid-March 2022. Notes and comments can be entered in the form provided and submitted by email. Further information can be found on the EMA website.