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  • Regulatory NewsRegulatory News

    EU Lists First Notified Body Under MDR

    BSI United Kingdom (UK) became the first notified body (NB) to be officially designated as an NB under the Europe Union’s (EU) medical device regulation (MDR). The new NB designation—the first-of-its-kind to be listed in the European Commission’s New Approach Notified and Designated Organizations (NANDO) database—comes months before the timeline the Notified Bodies Operations Group had estimated in 2017 guidance for NB designation and notification. The scope of B...
  • Regulatory NewsRegulatory News

    Falsified Medicines Directive: MHRA Responds to Comments, Addresses Brexit Impact

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD) .   The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/16...
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    MHRA Expands on ‘No-Deal’ Brexit Preparations for Drugs, Medical Devices

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued new guidance on Thursday to propose and further clarify certain regulatory positions in case of a “no-deal” scenario as Brexit looms around the corner. The 14-page guidance document covers the current and possible future regulatory space for medicines and medical devices brought into the UK market, as well as clinical trials conducted in the UK. It was developed based on responses to MHRA’s Octob...
  • Regulatory NewsRegulatory News

    ABPI Questions Lack of Details in Latest UK Update on No-Deal Brexit

    The UK’s Secretary of State for Health and Social Care Matt Hancock sent letters Friday on Brexit preparations for medicines supplies, offering details that the pharmaceutical industry group said need to be fleshed out further in the lead up to March 2019. In the event of a no deal scenario, the revised cross-Government planning assumptions show that there will be significantly reduced access across the short straits crossings into Dover and Folkestone for up to six mon...
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    Draft Brexit Agreement Moves Forward on Shaky Ground

    EU and UK negotiators on Wednesday advanced a draft agreement setting terms for the UK’s withdrawal from the EU in March 2019 and the two parties’ relationship during a 21-month transition period.   The agreement is being sent to the EU27 member states for consideration and must clear the UK Parliament before the negotiations can move to the next phase and avoid the possibility of a “No-Deal” scenario.   However, the deal appears to be in jeopardy after Brexit secr...
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    EU Regulatory Roundup: Industry Finds Fault With UK Vision for Drug Regulation After Brexit

    Welcome to our European   Regulatory Roundup, our weekly overview of the top EU regulatory news.   Industry Finds Fault With UK Vision for Drug Regulation After Brexit   British biopharma trade groups have spoken out against changes to drug regulation that could be enacted in the event of a no-deal Brexit. The trade groups found fault with proposals for how the Medicines and Healthcare products Regulatory Agency (MHRA) will handle orphan drugs, regulatory fees, ...
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    MHRA Consults on ‘No-Deal’ Brexit Options

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) wants to know what industry and others think of how legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no implementation period. The consultation covers no-deal proposals on medicines, clinical trials and medical devices. MHRA notes that in the unlikely event of a no-deal scenario, it would be a stand-alone medi...
  • Regulatory NewsRegulatory News

    Brexit: MHRA Promises 'No Sudden Changes' to UK Regulations

    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday reassured drugmakers that there will be no sudden changes to the country's regulatory framework when it leaves the EU in March 2019. In December, the UK and European Council agreed to advance Brexit negotiations to a second phase , and adopted guidelines for the continued talks, noting the UK's preference for a limited transition period under EU rules and regulations. The UK and EU also is...
  • European Regulatory Roundup: France Targets 80% Biosimilar Penetration by 2022 (4 January 2018)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news . Ireland Offers to Waive Certain Fees to Ease Impact of Brexit Ireland is offering to waive the fee for certain Brexit-triggered regulatory requests. The offer will allow companies to change their reference member state (RMS) from the United Kingdom to Ireland for free. Officials from the Health Products Regulatory Authority (HPRA) of Ireland made the offer in guides on ...
  • Regulatory NewsRegulatory News

    EMA: Amsterdam HQ Won't Be Ready in Time for Move

    The European Medicines Agency (EMA) on Friday said that its new headquarters in Amsterdam will not be complete until November 2019, eight months after the agency must move from its current offices in London. EMA's Management Board was briefed on the agency's relocation plans at its meeting earlier this week, and said it was pleased with accommodations offered by the Dutch government. The announcement comes less than a month after the European Council chose Amsterdam t...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: Critical Moment for EMA (15 December 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Commission Creates Roadmap for Evaluation of Pediatric Rare Disease Legislation The European Commission has created a roadmap for evaluating legislation covering pediatric rare diseases. Officials are embarking on the nearly two-year evaluation to understand why regulations on pediatric and orphan medicines have failed to translate into the hoped-for medical advances. ...
  • Regulatory NewsRegulatory News

    European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA’s Exit (7 December 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. EU Stands Firm on Demand for UK to Pay for EMA’s London Exit The European Commission has reiterated its demand for the UK to cover the cost of the European Medicines Agency’s (EMA) withdrawal from London. That would mean the UK paying the €400 million ($470 million)-plus bill EMA will face as result of breaching its rental agreement. European officials first stated th...