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Results: 1-10 of 190

EMA clarifies new variation classification categories
  • Hogan Lovells
  • European Union
  • February 17 2014

On 10 February 2014, the European Medicines Agency ("EMA") published a revised Questions & Answers document. The document supports the implementation


The EMA continues its work towards the implementation of the policy on the publication and access to clinical trial data
  • Hogan Lovells
  • European Union
  • December 19 2013

A press release published by the EMA on 17 December 2013 suggests that the Agency may be moving away from its original plan to have its planned


European Commission releases Implementation Report on rare diseases
  • Hogan Lovells
  • European Union
  • September 15 2014

On 5 September 2014, the European Commission released the Implementation report on the Commission Communication on Rare Diseases: Europe's challenges


European Commission Action Plan on Antimicrobial Resistance
  • Hogan Lovells
  • European Union
  • March 3 2015

On 26 February 2015, the European Commission published a progress report concerning the Commission's five year Action Plan on Antimicrobial


The EMA publishes new biosimilars guideline on non-clinical and clinical issues
  • Hogan Lovells
  • European Union
  • January 15 2015

Following its adoption by the Committee for Medicinal Products for Human Use ("CHMP") on 18 December 2014, the European Medicines Agency ("EMA"


EDQM publishes draft guidelines on endotoxins, pyrogens and sterile products
  • Hogan Lovells
  • European Union
  • October 23 2014

The European Directorate for the Quality of Medicines ("EDQM") has published draft revisions to its Guidelines for Using the Test for Bacterial


EMA launches new version of EudraCT
  • Hogan Lovells
  • European Union
  • October 22 2013

On 11 October 2013, the European Medicines Agency (“EMA”) launched a new version of the European Clinical Trials Database (“EudraCT”) This new Version


European Commission proposes overhaul of EU medical devices regulation
  • Hogan Lovells
  • European Union
  • September 27 2012

On 26 September 2012, the European Commission published two draft Regulations intended to replace the current Medical Devices Directive, the Active Implantable Medical Devices Directive, as well as the In Vitro Diagnostic Medical Devices Directive


EU close to deal on foods for particular nutritional uses?
  • Hogan Lovells
  • European Union
  • December 4 2012

The European Parliament and the Council appear to have reached agreement, in principle, on the text of a draft Regulation on food intended for infants and young children and food for special medical purposes


Directive 201226EU of the European Parliament and the Council of 25 October 2012 amending directive 200183EC as regards pharmacovigilance
  • Hogan Lovells
  • European Union
  • October 31 2012

The directive of 25 October 2012 amending directive 200183EC as regards pharmacovigilance was published in the Official Journal of the European Union on 29 October 2012