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PV Hot Topics

  • Further to the consultation on a draft rule initiated in 2009, the FDA has now issued the final rule describing postmarketing safety reporting requirements that apply to combination products, which refers to products with two or more constituents that belong to different types of regulated products (i.e. drugs, devices, and biologicals).
  • The EMA has now released the final guideline that outlines how Post-Authorisation Efficacy Studies (PAES) should be designed by companies to support regulatory decision making, which will come into effect on 01-Jun-2017.
  • The EMA has published a new document which provides a scientific discussion on the methods used forroutine signal detection in EudraVigilance. The document entitled “Screening for adverse reactions in EudraVigilance” updates and supersedes the previous guideline on the use of statistical signal detection in EudraVigilance.
  • New guidance documents for Safety Reporting in Clinical Trials have been implemented in Czech Republic and Australia, which bring simplified requirements for the submission of safety information to concerned stakeholders.
  • The French Agency has decided to start the process for suspending Uvesterol D as a precautionary measure after the death of a newborn at the end of December 2016 was associated to the mode of administration of the product.