News from France

08 Jan News from France

The EDQM has organised a Webinar for January 17th on elemental impurities to assess the impact of the implementation of ICH guideline Q3D, which is applicable for new marketing authorisations since June 2016, on the texts of the European Pharmacopoeia and on the assessment of CEP applications.  More info available here.

The eCTD specifications of EU Module 1 changed to version 3.0.1, currently in force since July 1st, 2016. The eCTD validation criteria also changed to version 6.1, to be in line with the updated EU Module 1.

In France, the Minister of Social Affairs and Health launched a national information campaign on generic medicinal products in order to reinforce confidence and knowledge on these medicines.

The ANSM published a draft of recommendations regarding the names of medicinal products, which is subject to a public consultation until November 30, 2016.

Medipha Santé is now part of the GEMME, the association « Generic same medicine » which represents French professionals and manufacturers of generic and biosimilar medicinal products.

For more information visit our French member at http://www.medipha-sante.fr/