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

 
  • Regulatory NewsRegulatory News

    EMA Updates on Priorities Ahead of Netherlands Move

    Two months out from when the UK will officially exit the EU, the European Medicines Agency (EMA) on Wednesday provided an update on its move to the Netherlands and clarified its priorities in the new year.   With the anticipated loss of 25% of its staff , EMA says it must continue to prioritize its activities according to its business continuity plan (BCP) through at least the first half of 2019.   "The focus will be on the authorization, maintenance and supervi...
  • Regulatory NewsRegulatory News

    EMA Draft Guidance Seeks to Speed New Antibiotics Development

    The European Medicines Agency (EMA) is seeking comment on a new draft guideline that could help industry use of pharmacokinetics (PK) and pharmacodynamics (PD) analyses to speed the development of novel antibiotics that target multidrug-resistant bacteria and address unmet medical needs. Background Like in the US, the growth of bacteria resistant to a range of antibiotics, along with the need for new antibiotics to treat patients with limited or no treatment options, sp...
  • RAPS' LatestRAPS' Latest

    New RAPS Netherlands Chapter Announced

    A group of regulatory professionals in the Netherlands has formed a new official RAPS chapter there. The RAPS Netherlands Chapter is the newest in RAPS’ global chapter network and the second in Europe along with the RAPS Switzerland Chapter. The deal became official after representatives signed an agreement with RAPS leaders at 2014 RAPS: The Regulatory Convergence in Austin, TX, in October. RAPS now has 18 chapters in six countries, as well as affiliated networking groups...
  • China Signs MOU with the Netherlands

    • 07 May 2012
    China's State Food and Drug Administration has further expanded its international collaborative efforts in regulatory matters by concluding a Memorandum of Understanding (MOU) with the Ministry of Health of the Netherlands. The new MOU calls for expanded cooperation between the two countries on matters relating to the regulation of drugs and medical devices. A Dutch company had exported to China breast implants containing industrial grade silicone that were supplied by...
  • Dutch Regulatory Authority Echoes Warning on Faulty Breast Implant Products

    • 19 March 2012
    The Dutch Health Ministry is warning thousands of women about the risks associated with breast implant products manufactured by French firm Poly Implant Prothese (PIP) after becoming concerned about their potential to rupture, reports Reuters . The implants were reportedly made with industrial-grade silicone and may be rupturing at an abnormally high rate. In light of the potential risks, the Dutch Health Ministry is asking women to consider having the implants removed ...