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Results: 1-10 of 335

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


New Belgian Innovation Office to Accelerate Availability of Novel Medicines
  • Hogan Lovells
  • European Union
  • December 14 2016

In July 2016, the Belgian Agency for Medicines and Healthcare Products (“FAMHP”) took steps to establish a National Innovation Office as part of the


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


European Medicines Agency fine-tunes Guideline on fixed combination medicinal products
  • Hogan Lovells
  • European Union
  • May 22 2015

On 13 May 2015, the European Medicines Agency released for consultation the draft Guideline on the clinical development of fixed combination


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 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


The European Commission adopts two new Directives concerning human tissues and cells
  • Hogan Lovells
  • European Union
  • April 29 2015

On 8 April 2015, the European Commission adopted Directive (EU) 2015565 amending Directive 200686EC as regards certain technical requirements for


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


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


ANSM on the de-notification or termination of notified bodies’ activities
  • Hogan Lovells
  • European Union, France
  • November 21 2016

On 14 November 2016, the French National Agency for Medicines and Health Products Safety (“ANSM”) issued the English version of an information