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Results: 1-10 of 316

EMA and FDA set up new working group on rare diseases
  • Hogan Lovells
  • European Union, USA
  • October 6 2016

On 26 September 2016, a new EU-US collaboration between the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA


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


The EMA continues its work towards the implementation of the policy on the publication and access to clinical trial data
  • Hogan Lovells
  • European Union
  • December 19 2013

A press release published by the EMA on 17 December 2013 suggests that the Agency may be moving away from its original plan to have its planned


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


The Court of Justice of the European Union orders the review of an injunction blocking the release of clinical study data by the European Medicines Agency
  • Hogan Lovells
  • European Union
  • December 6 2013

On 28 November 2013, the Court of Justice of the European Union ("CJEU") set aside the order of the General Court of the European Union ("General


European Court rules that products can be classified as both medical devices and medicinal products in the EU
  • Hogan Lovells
  • European Union
  • October 11 2013

On 3 October 2013, the Court of Justice of the European Union issued a judgment in Case C-10912, which concerned the implications of


European Commission fines for delaying market entry of generic medicines
  • Hogan Lovells
  • European Union
  • June 20 2013

The European Commission yesterday imposed a fine of Euro 93.8 million on Danish pharmaceutical company Lundbeck and fines totalling Euro 52.2 million


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


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