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Results: 1-10 of 184

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


European Medicines Agency commences patient consultations during the benefitrisk assessment of medicinal products
  • Hogan Lovells
  • European Union
  • September 30 2014

The European Medicines Agency (“EMA”) has launched a pilot project to consult with patients during the assessment of the benefitrisk profile of


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


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"


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


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


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 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