RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • Regulatory NewsRegulatory News

    Drug Sampling and Testing: EMA Releases 20 Year Report, Will Expand Program to Biosimilars

    The European Medicines Agency (EMA) and European Directorate for the Quality of Medicines and Healthcare (EDQM) on Thursday released a report detailing findings from EMA’s drug sampling and testing program over the last 20 years.   EMA says it plans to extend the program to include biosimilars and that it will expand the generic sampling and testing program first launched in 2011 to include products authorized via the mutual recognition and decentralized procedures. ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (31 March 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Cardiovascular Working Party Signs off on Final Reflection Paper, Guidelines The Committee for Medicinal Products for Human Use (CHMP) has adopted a pair of final regulatory documents created by the Cardiovascular Working Party (CWP). Most significantly, the committee has adopted final guidelines on clinical trials of treatments for venous thromboembolism (VTE). Having bee...
  • With EDQM Absent, EFPIA Launching Own Anti-Counterfeit Strategy

    • 03 May 2012
    • By
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) announced it has signed on to a Memorandum of Understanding (MoU) that it says will help to set up a harmonized system of international standards to prevent counterfeit products from entering or proliferating within the pharmaceutical supply chain. EFPIA said the MoU, reportedly developed jointly between groups representing pharmacists, wholesalers and distributors, adopts what is known at the ...
  • EDQM Continuing Development of New, Comprehensive Anti-Counterfeiting Strategy

    • 18 April 2012
    • By
    The European Directorate for Quality in Medicines and Healthcare ( EDQM ), the Council of Europe's (EC) pharmaceutical standards body, announced it is continuing to develop and expand a new anti-counterfeiting strategy it says will reduce pharmaceutical-related crime. In its 18 April announcement, EDQM said the multi-layer legislative strategy aims to increase, among other things, training for inspection officials from EC member states, increased inspection and testing a...
  • Global API Inspection Scheme Continues to Ramp Up, Calls for Additional Members

    An active pharmaceutical ingredient (API) inspection program involving many of the world's premiere global regulatory bodies announced recently its intent to standardize the inspection schemes of the member nations and advance "administrative simplification." The as-yet-unnamed program, which includes the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), Australia's Therapeutic Goods Administration (TGA), the World Health Organization (WHO), the...