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  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Seeks Feedback on Planned Changes to Medical Device Rules

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Seeks Feedback on Planned Changes to Medical Device Rules   Australia’s Therapeutic Goods Administration (TGA) is seeking feedback on two sets of medical device proposals. The proposals address essential principles for safety and performance and the regulatory requirements for medical device systems and procedure packs.   Both documents grew out of the Austra...
  • Regulatory NewsRegulatory News

    MHRA Explains No-Deal Brexit Pharmacovigilance Requirements

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday issued guidance for drugmakers on how to comply with pharmacovigilance requirements in the event the UK leaves the EU without a deal later this month.   The guidance comes the same day as the UK Parliament voted down a revised version of the Brexit deal the UK and EU negotiated last November.   After the vote, UK Prime Minister Theresa May reiterated her commitment to leaving the EU with...
  • Regulatory NewsRegulatory News

    EU Regulatory Roundup: Rising Complexity Drives Sharp Fall in MHRA Pharmacovigilance Inspections

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   EMA Advises Novartis on use of eSource Direct Data Capture in Clinical Trials   The European Medicines Agency (EMA) has outlined its views on eSource direct capture of clinical trial data in response to questions from Novartis. EMA sees no theoretical obstacles to the use of the technology in a way that complies with good clinical practices (GCPs), but thinks sponso...
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    EMA Announces Pharmacovigilance Fee Increase

    Pharmacovigilance fees payable to the European Medicines Agency (EMA) were increased by 1.7% on Thursday to account for inflation in 2017.   Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014, which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices.   The increased fee rate was established under Commissioner Delegated Regulation (EU)...
  • Regulatory NewsRegulatory News

    EMA: Pharmacovigilance Fees to Rise in 2018

    The European Medicines Agency (EMA) on Wednesday said it expects fees paid by drugmakers for pharmacovigilance applications to rise by 1.4% in mid-January 2018. Pharmacovigilance fees in in the EU are set by Regulation (EU) No 658/2014 , which includes provisions for the European Commission to adjust the fees to keep up with the rate of inflation as measured by the European Index of Consumer prices. Due to a low level of inflation in 2015 (0.2%), the Commission in 20...
  • Regulatory NewsRegulatory News

    EMA Makes Final Preparations Ahead of New EudraVigilance Launch

    With the 22 November launch date for its revamped EudraVigilance system rapidly approaching, the European Medicines Agency (EMA) on Wednesday provided some last minute updates on what to expect during the transition to the new system. New EudraVigilance System The new system, developed in response to changes brought on by the EU's pharmacovigilance legislation that went into effect in 2012, promises to improve adverse event reporting and safety monitoring. Specifical...
  • Regulatory NewsRegulatory News

    Making Sense of FAERS: Researchers Suggest Fixes to FDA's Adverse Event Database

    A team of researchers from Novartis, Oracle Health Sciences and the University of California, San Francisco say the US Food and Drug Administration's (FDA) adverse drug reaction database could be improved by grouping drugs by their chemical structure and automating certain reporting functions. In a paper appearing in eLife earlier this month, the researchers say such changes could help address several major challenges to interpreting data in FDA's adverse event reporti...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Fixes Price of Orthopedic Knee Implants, Tells Manufacturers to Maintain Supply India has capped the price of orthopedic knee implants. The imposition of ceiling prices continues the National Pharmaceutical Pricing Authority’s (NPPA) push to control the cost of medical devices sold in India. Months after setting limits on the prices of coronary stents, NPPA has ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Revises Pharmacovigilance Guideline After Danish Agency Spots 'Big Problem' (10 August 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Revises Pharmacovigilance Guideline After Danish Regulators Spot 'Big Problem' The European Medicines Agency (EMA) has revised its good pharmacovigilance practice (GVP) guideline after Danish regulators flagged up a “big problem” with a draft version. EMA's change mitigates the risk of marketing authorization holders (MAHs) and national agencies independently mergi...
  • Regulatory NewsRegulatory News

    EMA Reports Rise in Pharmacovigilance Inspections in 2016

    In a report released on Tuesday, the European Medicines Agency (EMA) said the number of pharmacovigilance inspections for centrally authorized products rose in 2016, mainly driven by an increase in routine inspections carried out under national inspection programs. Background In the EU, routine pharmacovigilance inspections are typically carried out by national regulators to check that marketing authorization holders have the personnel, systems and facilities in place t...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EU Device Regulations Come Into Force Swissmedic Clarifies Pharmacovigilance Process (1 June 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU Regulatory news. EU Medical Device Regulations Come Into Force, Starting Multi-Year Transition Period The European Union medical device and in vitro diagnostic (IVD) regulations have come into force. The passing of the date marks the start of the phased, multi-year introductions of requirements set out in the two documents. In the immediate term, the entry of the long-gestating regu...
  • Regulatory NewsRegulatory News

    UK Pharmacovigilance Post-Brexit: Lots of Questions, Few Answers

    No one knows what UK pharmacovigilance will look like after the UK leaves the EU, and that uncertainty puts the many Qualified Persons Responsible for Pharmacovigilance (QPPVs) residing in the UK in a precarious position. According to the UK’s independent academic Drug Safety Research Unit, which organized a meeting last week on the topic of pharmacovigilance post-Brexit, "At worst, this will deal a severe blow to UK pharmacovigilance" as pharmaceutical companies "...