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Results: 1-10 of 290

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


EU Parliament committee approves draft Regulations overseeing the revision of EU medical devices legislation
  • Hogan Lovells
  • European Union
  • September 26 2013

On Wednesday 25 September 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (ENVI) voted on two draft


EMA issues Draft Guideline on weight control products
  • Hogan Lovells
  • European Union
  • August 11 2014

On 31 July 2014, the European Medicines Agency ("EMA") issued draft guidelines on the clinical evaluation of new medicinal products used to promote


Commission authorised three proprietary general function health claims
  • Hogan Lovells
  • European Union
  • September 5 2013

On 3 September 2013, the European Commission adopted Regulation (EU) No 8512013 authorising three general function health claims based on


European Medicines Agency updates guidelines on good pharmacovigilance practices
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") updated its guidelines on Good Pharmacovigilance Practices ("GVP Guidelines"). The update


European Commission clarifies position on post-authorisation efficacy studies
  • Hogan Lovells
  • European Union
  • May 8 2014

On 10 April 2014, the European Commission ("Commission") adopted Commission Delegated Regulation (EU) No 3572014 as regards situations in which


New European Union Clinical Trials Regulation adopted on 14 April 2014
  • Hogan Lovells
  • European Union
  • April 15 2014

On 14 April 2014, a new Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and


EMA publishes new Union procedure on the management of pharmacovigilance inspection findings
  • Hogan Lovells
  • European Union
  • July 1 2014

On 20 June 2014, the European Medicines Agency (hereafter "EMA") published a new European Union procedure on the management of pharmacovigilance


The European Medicines Agency publishes draft guideline on process validation for biologics
  • Hogan Lovells
  • European Union
  • May 9 2014

On 25 April 2014, the European Medicines Agency ("EMA") published a Draft Guideline on process validation for the manufacture of


EFPIA launches new clinical trial data portal gateway
  • Hogan Lovells
  • European Union
  • May 27 2014

On 20 May 2014, the European Federation of Pharmaceutical Industries and Associations ("EFPIA") launched a new clinical trials data portal gateway