The main RAPS website will offline for several minutes at 5 PM on 22 October 2021 due to scheduled maintenance.
We apologize for any inconvenience during this time.

  • 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 "...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes Electronic Platform to Monitor Drug Supply Chain The Indian government is proposing to create an electronic platform to monitor the drug supply chain. Officials want all manufacturers, distributors and pharmacies to register on the platform and upload details of batches they supply and receive in an attempt to raise drug standards in India. India’s Mini...
  • Regulatory NewsRegulatory News

    Four Pharma Companies Lead in Regulatory, Legal Compliance

    Gilead, Novo Nordisk, Eisai and AbbVie have been singled out as the only companies that were not found by a court or regulator over the past two years to have breached criminal or civil laws or codes of conduct related to corruption or unethical marketing, according to the 2016 edition of the Access to Medicines Index. Background Every two years since 2008, the Access to Medicine Foundation publishes a ranking system analyzing 20 different pharmaceutical companies again...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (25 August 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. MHRA Updates Guidance on Determining Whether an app is a Medical Device The United Kingdom Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance on determining whether an app is classified as a medical device. The new guidance features revised flowcharts to help software developers understand whether an app needs a CE mark. MHRA released ...
  • Regulatory NewsRegulatory News

    EMA Releases List of Medical Events for Pharmacovigilance Monitoring

    The European Medicines Agency (EMA) has released a list of standardized terms describing medical events it says will be used by the agency and other European regulators to identify suspected adverse events. EMA says the list will assist it and other regulators to prioritize the review of suspected adverse events that "deserve special attention, irrespective of statistical criteria used to prioritize safety reviews," and contribute to the agency's day-to-day pharmacovigil...
  • Regulatory NewsRegulatory News

    EMA Adopts New Biologic, Biosimilar Pharmacovigilance Guidance

    The European Medicines Agency (EMA) on Monday announced new recommendations for monitoring the safety of biologics and biosimilars. The guidance will take effect on 16 August 2016. The new recommendations are part of a new chapter of EU good pharmacovigilance practice (GVP) guidelines, titled Product- or population specific considerations II: Biological medicinal products . Background Pharmacovigilance is the process of monitoring the use of drugs after they have ente...
  • Regulatory NewsRegulatory News

    EU Regulators Tout Progress on Pharmacovigilance Since New Legislation Enacted

    The European Commission (EC) and European Medicines Agency (EMA) say their combined efforts have resulted in improved drug safety monitoring since new legislative requirements went into effect in 2012, according to a report released by the EC on Monday. "The analysis shows that the new system has been successful at detecting safety issues more quickly, thus enabling regulators to take rapid action when needed and provide advice and warnings to users of medicines," EMA wr...
  • Regulatory NewsRegulatory News

    Off-Label Drug Use and Pharmacovigilance: EMA Outlines What MAHs Need to Collect and Report

    Pharmaceutical companies operating in the EU will need to collect and report information on the off-label use of their medicines under new obligations making their way from draft to final form at the European Medicines Agency (EMA) this summer. In late April, EMA offered a reflection paper , open for comment through 29 July, which offers the agency’s proposal for the collection and reporting of information on off-label use for marketing authorization holders (MAHs), in ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Sets Up Antimicrobial Monitoring Program (14 April 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Sets out 5-Year Strategy for Antimicrobial Monitoring Program The European Medicines Agency (EMA) has published a draft strategy for the next five years of its program to monitor the use of antimicrobials. Over the period covered by the document, EMA plans to continue expanding the number of countries from which it gathers data with a view to ultimately covering ev...