Posted on 05 Nov 2018

Regulatory News - November 2018

  • EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) elected Dr. Martin Huber, PRAC member Germany since 2012, as the new vice-chair to take over from Dr Álmath Spooner. Dr. Huber is Head of the unit 'PRAC, Legal Status, Adverse Reaction Reports, Medication Errors' at, in Germany.
  • The EMA and the European Commission have published additional information material on biosimilar medicines, as part of their ongoing collaboration to improve understanding of biosimilars across the European Union (EU). A biosimilar is a biological medicine that is highly similar in all essential aspects to a 'reference' biological medicine already authorised.
  • The new material includes an animated video for patients that explains key facts on biosimilar medicines and how EMA works to ensure that they are as safe and effective as their reference biological medicines. The video is available in eight European languages
  • The Food and Drug Administration announced the availability of a final guidance for industry entitled ''Physiologically Based Pharmacokinetic Analyses—Format and Content'.' This guidance outlines the recommended format and content for a sponsor or applicant to submit physiologically based pharmacokinetic (PBPK) analyses to FDA to support applications including, but not limited to, investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications (BLAs), or abbreviated new drug applications (ANDAs).