Labelling exemption requests under article 63 of Directive 2001/83/EC examined by QRD group

Europe – Annex to the European Commission guideline on ‘Excipients in the labelling and...

This document updates and replaces the Annex previously included in the Guideline CPMP/463/00 Rev. 1. It is an integral part of the European Commission guideline...
The impact of Mutual Recognition Agreement between the European Union and the United States as of 27 June 2019 : Questions & Answers

Europe – Reflection paper on regulatory requirements for the 5 development of medicinal products...

Chronic, non-infectious liver diseases are a medical field of high unmet medical needs. At the same time, the specifics of the diseases create major challenges...
Ph. Eur. 10th Edition - Now available!

Europe – Update on the review of CEP applications for sartans

Following new information recently received by EDQM about the detection of low levels of N-nitrosodiethylamine (NDEA) in Valsartan manufactured by MYLAN LABORATORIES Ltd ,...
FDA Finalizes Guidance on Delayed Graft Function in Kidney TransplantationRay Imaging Devices With International Standards

Europe – Guideline on equivalence studies for the demonstration of therapeutic equivalence for locally...

This guideline refers to medicinal products that are applied locally and intended to exert their effect locally at specific sites(s) in the gastrointestinal (GI)...
Implementation of the Medical Devices and In Vitro Diagnostic Medical Devices Regulations ((EU) 2017/745 and (EU) 2017/746) : Questions & Answers

Europe – Guideline on the quality of water for pharmaceutical use

Water is one of the major commodities used by the pharmaceutical industry. It may be present as an excipient or used for reconstitution of...
Hépatite C. Le laboratoire Gilead baisse le prix de ses coûteux traitements de 20 %

France – Hépatite C. Le laboratoire Gilead baisse le prix de ses coûteux traitements...

Epclusa®, Sovaldi®, Harvoni® et Vosevi®. Cette information a été publiée au Journal Officiel et s'applique immédiatement pour la délivrance en ville et à l'hôpital....
NICE issues final draft guidelines for Novartis’ Kymriah

UK – NICE issues final draft guidelines for Novartis’ Kymriah

The decision paves the way for young people with relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL) to access Novartis’ Kymriah (tisagenlecleucel) through the...
Médicaments : une évaluation rigoureuse et scientifique par la HAS

France – Médicaments : une évaluation rigoureuse et scientifique par la HAS

Selon quels critères recommande-t-on ou non le remboursement d’un médicament ? Après avoir obtenu une autorisation de mise sur le marché (AMM), les médicaments sont...
Institutional Review Board (IRB) submissions: Necessary for usability tests?

USA – FDA touts record-breaking number of October generic approvals

In October, the Food and Drug Administration approved 110 generic drugs and tentatively approved 18 generic drugs for a total of 128 approval actions. The...
NICE ‘OK’ for Lynparza

UK – Final NICE green light for Pfizer’s Mylotarg

The guidelines, which do not cover the treatment of acute promyelocytic leukaemia, endorse NHS funding for patients aged 15 years and over, but only...

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