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  • Regulatory NewsRegulatory News

    European Regulatory Roundup: MHRA Offers Draft Guidance on Device and Combo Products (16 June 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Parliamentary Committee Calls for Urgent Creation of Post-Brexit Contingency Plans A United Kingdom parliamentary committee has called for the government to immediately establish contingency plans to protect scientific organizations from the fallout of the public voting to leave the European Union. The committee made the recommendation after its analysis of the situ...
  • Regulatory NewsRegulatory News

    EU's New Centralized Pharmacovigilance Portal Gets Endorsement from EMA

    A year from now, drugmakers in the EU will be required to submit postmarket safety reports to an online central repository, the European Medicines Agency (EMA) has confirmed. Background In January 2015, EMA announced the launch of a central repository , hosted on the eSubmissions website, for submitting periodic safety update reports (PSURs). In the EU, drugmakers are required to submit PSURs to EMA at regular intervals. These reports are evaluated and used to en...
  • China: SFDA Issues New PSUR Guidance

    New guidance on submitting periodic safety update reports (PSURs) for drugs was released by China's State Food and Drug Administration (SFDA) on 6 September.  The guidance conforms to the harmonized PSUR standards developed by the International Conference on Harmonization [ICH E2C (R1)].  Foreign importers and joint ventures must submit Line Listings, summary tables (Summary Tabulations) and the company's core data table (Company Core Data Sheet, CCDS) transla...
  • EMA Asks for Feedback on Pharmacovigilance Legislation Implementation

    The European Medicines Agency (EMA) is calling on industry to comment on its draft list of European Union reference dates for Period Safety Update Reports (PSURs) that are being implemented as a result of the recent pharmacovigilance legislation. "The purpose of the consultation is to ensure completeness and correctness of the information before the list is adopted later this year," said EMA in a prepared statement released 4 April. "The list is intended to optimize the...