EMA Regulatory News

Jan 15th 2018

New EMA Services to improve quality of submissions and help ensure validation          Pre-authorisation    A list … continue reading →

Have you ever thought of Early Access Programs (EAP) for your patients? A French cohort ATU example.

Dec 5th 2017

At European Community level, Article 5 (1) of Directive 2001/83/EC, duly amended provides an option for Member States to authorise … continue reading →

EU-US Mutual Recognition of Manufacturer Inspections – start of operational phase

Nov 27th 2017

On 1st November 2017, the European Union and the United States entered into a new phase of the agreement to recognise … continue reading →

Free seminar on ‘Pharmacovigilance considerations in drug development’

Nov 21st 2017

Where: Evenlode Boardroom, Milton Park Innovation Centre When: 22 November 2017 at 10:00 Topics: Early-to-late phase clinical trial pharmacovigilance Preparation … continue reading →

Brexit stakeholder meeting – 31st August 2017

Oct 23rd 2017

Following the UK’s triggering of Article 50 to leave the European Union, the HPRA, together with medicines agencies in Europe, … continue reading →