News from France

News from France

February 2016 (not added on our website yet) :

  • EU Module 1 eCTD specifications changed to version 3.0.1, and are in force since July 1st, 2016. eCTD validation criteria also changed to version 6.1, to be in line with the updated EU M1.
  • Medipha Santé will be attending the CPhI congress 2016, which will take place in Barcelona from October 4th to 6th, and will be available at stand 3N40.

May 2016 : 

  • ANSM has been through a process of reorganisation. As a result, the « Products » departments have been reorganised in order to rebalance their activities and improve the performance of the Agency.
  • A new report on biosimilar medicines is available on the ANSM website (available in French only). It suggests the possibility of interchangeability during treatment between two biological medicines (reference medicine and/or biosimilar medicine) under certain circumstances.

June 2016: 

  • National guidelines have been issued by the ANSM on the submission of good quality translations following Mutual Recognition Procedure (MRP) or Decentralised Procedures (DCP) (available in French only).

Originally published in May and June, 2016, by Medipha Santé at