UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit

Europe – EMA’s Brexit plans ensure Agency’s focus on medicines evaluation and supervision

A report on EMA’s 24 September 2018 meeting with industry stakeholders to discuss the UK’s withdrawal from the European Union and the impact on the operation of the centralised...
Stem cell-based Parkinson's therapy tested in Japan

Japan – Stem cell-based Parkinson’s therapy tested in Japan

Japanese researchers said on Friday (Nov 9) they have transplanted stem cells into the brain of a patient in the first stage of an...
New drug options, risk factors added to U.S. heart guidelines

USA – New drug options, risk factors added to U.S. heart guidelines

Updated U.S. guidelines on heart health advise more personalized assessment of risk as well as two newer types of cholesterol-lowering drugs for people at...
MÉDICAMENTS en LIGNE : Les conditions d’une automédication en toute sécurité

France – MÉDICAMENTS en LIGNE : Les conditions d’une automédication en toute sécurité

Depuis le 1er mars 2013, ce sont près de 3.500 spécialités de médicament qui peuvent être vendues sans ordonnance. Ainsi, à titre d’exemple, qu'il...
L’ANSM décide, de retirer du marché des implants mammaires macrotexturés et des implants mammaires à surface recouverte de polyuréthane, par mesure de précaution

France – L’ANSM met en place un dispositif accéléré d’autorisation d’essais cliniques (Fast Track)

Afin de permettre un accès plus rapide aux traitements innovants pour les patients, l’ANSM met en place deux circuits courts (Fast Track) qui vont...
WORKING WITH STAKEHOLDERS TO IMPROVE AVAILABILITY OF MEDICINES IN THE EU

Europe – WORKING WITH STAKEHOLDERS TO IMPROVE AVAILABILITY OF MEDICINES IN THE EU

The Task Force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines  is organising a two day-workshop (8-9 November 2018)...
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen FDA’s expanded access program

USA – Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to strengthen...

Since the 1970s, the FDA has helped to facilitate access to promising investigational medical products for patients with serious or immediately life-threatening diseases who...
EMA Issues Guideline on GVP Considerations for Pediatric Populations

Europe – EMA Issues Guideline on GVP Considerations for Pediatric Populations

The European Medicines Agency (EMA) on Wednesday released its recently adopted guideline on good pharmacovigilance practices (GVP) module providing recommendations for pharmacovigilance in pediatric...
NICE says no to expanding use of AZ’ Lynparza

UK – NICE says no to expanding use of AZ’ Lynparza

The drug’s recent expanded approval in Europe allows its use for maintenance treatment of relapsed, platinum-sensitive, high-grade epithelial ovarian, fallopian tube or primary peritoneal...
BREXIT : où en est-on ?

UK – Industry Finds Fault With UK Vision for Drug Regulation After Brexit

British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The...

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