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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


Life sciences: product regulation and liability in the European Union
  • Hogan Lovells
  • European Union, Global
  • June 5 2017

A structured guide to product regulation and liability laws in the European Union


EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials
  • Hogan Lovells
  • European Union
  • June 8 2017

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public


Commission opens public consultation on the EU Paediatric Regulation
  • Hogan Lovells
  • European Union
  • December 6 2016

On 15 November 2016, the European Commission (“the Commission”) opened its Second Report on Regulation (EC) No 19012006 of the European Parliament


EMA publishes draft guidance on medication errors for public consultation
  • Hogan Lovells
  • European Union
  • April 20 2015

On 14 April 2015, the European Medicines Agency ("EMA") published three draft guidance documents concerning medication errors for consultation. The


EMA confirms that access to clinical study reports for preparation of health technology dossiers will be permitted within the new EMA Disclosure Policy
  • Hogan Lovells
  • European Union
  • April 13 2015

According to the minutes of a meeting between the European Medicines Agency ("EMA") and the European Network for Health Technology Assessment


EMA begins publishing the outcome of safety reports concerning nationally authorised medicinal products
  • Hogan Lovells
  • European Union
  • July 20 2015

On 6 July 2015, the European Medicines Agency ("EMA") announced that it would begin publishing the outcome of single assessments of period safety


EMA permits the use of a comparator product authorised outside the EEA in clinical studies for biosimilars
  • Hogan Lovells
  • European Union
  • April 13 2015

The European Medicines Agency's ("EMA") revised overarching guideline on biosimilars("Guideline"), which was published on 23 October 2014, will come


Antitrust, Competition and Economic Regulation Quarterly Newsletter - Summer 2017
  • Hogan Lovells
  • European Union, Germany, Hong Kong, United Kingdom, USA
  • June 12 2017

There has been a spate of cases around Europe in which pharmaceutical companies have been accused of pricing at an excessive level. These started


EMA adopts new guideline on modified release dosage forms
  • Hogan Lovells
  • European Union
  • December 5 2014

On 27 November 2014, the European Medicines Agency (“EMA”) published its new guideline on the pharmacokinetic and clinical evaluation of modified