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Results: 1-10 of 380

EMA opens public consultation on ICH E11(R1) Guideline
  • Hogan Lovells
  • European Union
  • October 28 2016

On 13 October 2016, the European Medicines Agency ("EMA") opened for public consultation the Guideline concerning clinical investigation of medicinal


The European Medicines Agency issues an opinion on the principal mode of action of proanthocyanidins present in cranberry extracts
  • Hogan Lovells
  • European Union
  • November 10 2016

On 8 November 2016, the European Commission published the opinion of the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human


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


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


CJEU judgment on Merck Canada Inc. & Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals plc, case C-53913, 12 February 2015
  • Hogan Lovells
  • European Union
  • February 16 2015

The CJEU has recently clarified when patent and SPC rights can be relied on under the Specific Mechanism to prevent parallel imports within the EU


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EMA publishes Guide on access to unpublished documents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The European Medicines Agency (“EMA”) has published its Guide on access to unpublished documents (the “Guide“).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


Revised guideline adopted on core SmPC for plasma-derived fibrin sealant haemostatic products
  • Hogan Lovells
  • European Union
  • July 8 2015

On 25 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) adopted a revised Guidance on core SmPC for plasma-derived fibrin


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