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Results: 1-10 of 195

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"


EMA publishes draft guidance on medication errors for public consultation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On 14 April 2015, the European Medicines Agency ("EMA") published three draft guidance documents concerning medication errors for consultation.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


EU, UK: CJEU opinion delivered on the Specific Mechanism
  • Hogan Lovells
  • European Union, United Kingdom
  • October 23 2014

Advocate General Niilo Jääskinen’s opinion on the interpretation of the Specific Mechanism (in the case of Merck v Sigma (Case C-53913) was


EU: relatively high level of attention in the field of pharmaceutical products
  • Hogan Lovells
  • European Union
  • October 23 2014

Once more the General Court has confirmed that the relevant public in the field of pharmaceutical products - consisting both of medical professionals


European Medicines Agency adopts policy on publication of clinical data for medicinal products
  • Hogan Lovells
  • European Union
  • October 3 2014

On 2 October 2014, the European Medicines Agency (EMA) adopted its long awaited policy on the publication of clinical data for medicinal products


EMA publishes Guide on access to unpublished documents
  • Hogan Lovells
  • European Union
  • November 29 2014

The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide“). In accordance with European Union


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


European Parliament plenary vote on revised medical devices package
  • Hogan Lovells
  • European Union
  • October 25 2013

On 22 October 2013, the European Parliament voted, during a plenary session, on two draft Regulations intended to replace the current Medical Devices


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


EMA opens consultation on guidelines for core SmPC for human plasma derived products
  • Hogan Lovells
  • European Union
  • October 7 2014

On 1 October 2014 the European Medicines Agency ("EMA") opened a consultation on revisions to its guideline on core summary of product