Europe to revise drug similarity concept under orphan legislation

Home/Guidelines | Posted 12/08/2016 post-comment0 Post your comment

The European Commission announced on 27 July 2016 a proposal to review the concept of ‘similar medicinal products’ in the context of the orphan legislation.

Concept Paper

The aim of this revision is to improve the implementation of the regulatory framework and to adapt the text to technical progress.

After 15 years of implementation of the orphan legislation, the Commission is currently launching initiatives to improve the implementation of the regulatory framework with a view to ensure timely access to medicinal products. In this context, the Commission has decided to launch a targeted review of Commission Regulation (EC) No 847/2000 on the concept of similarity. In parallel, the Commission is also finalizing the revision of the 2003 Communication on Regulation (EC) No 141/2000 on orphan medicinal products (2003/C 178/02) which will be replaced by a notice.

In order to facilitate these revisions the Commission has released a consultation document for which it aims to collect views, relevant evidence and information from stakeholders to help it develop its thinking in this area.

Concept of ‘similar medicinal product’ in the context of the orphan legislation: adaptation to technical progress

Proposals for change include:
• removal of the definition of active substance
• definition of similar active substance.

The second proposal for changes in the definition of similar active substance affects both chemical and biological medicinal products, as well as radiopharmaceutical medicinal products.

The consultation document has been released for a consultation period from 29 July 2016 to 4 November 2016. Contributions may be sent by e-mail to

Related article
Biosimilars applications under review by EMA – April 2016

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2016 Pro Pharma Communications International. All Rights Reserved.

Source: Europa

comment icon Comments (0)
Post your comment
Related content
WHO guidelines on pharmaceutical pricing policies
Pay for Delay DrugsMoneyGeneric V13F21
Home/Guidelines Posted 24/09/2021
Mexico introduces new decree on health regulation
Home/Guidelines Posted 27/08/2021
Draft decree for prescribing generics in Costa Rica
46 MD001580
Home/Guidelines Posted 09/07/2021
Most viewed articles
About GaBI
Home/About GaBI Posted 05/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010