• RoundupsRoundups

    Euro Roundup: Switzerland moves to mitigate split from EU on device regulation

    Switzerland has adopted supplemental provisions to its new Medical Devices Ordinance (MedDO) to soften the impact of its split from the European Union. The action comes as the failure to update a mutual recognition agreement (MRA) erects barriers to trade between Switzerland and the EU.   Swiss medical device manufacturers have enjoyed barrier-free access to the EU single market since 2001. However, the EU refused to consider updating the MRA in light of the new EU ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. UK Tasks ex-GSK CEO With Highlighting Drugs Eligible for Accelerated Access Pathway The UK has tasked former GlaxoSmithKline CEO Sir Andrew Witty with highlighting products suitable for its incoming accelerated access pathway (AAP). Products that follow AAP will benefit from support with evidence generation and a more seamless journey to market, features the government ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EMA Gathers Global Drug Agencies, NGOs to Explain its Regulatory System The European Medicines Agency (EMA) is meeting with medicine agencies and non-governmental organizations (NGOs) to explain its regulatory system. EMA sees the education initiative helping other global regulators understand its system and, by extension, more effectively collaborate with its staff. ...
  • 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...