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  • Regulatory NewsRegulatory News

    US and EU Fully Implement Mutual Agreement on GMP Inspections

    The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on Friday said they have now fully implemented a plan that will allow member state regulators and FDA to mutually rely on each other’s good manufacturing practice (GMP) inspections of drug facilities. In addition to helping reduce redundancies in manufacturing inspections, the implementation of the Mutual Recognition Agreement (MRA) means that beginning Friday, pharmaceutical companies can sto...
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    Canadian Regulator and Regulatory Experts to Speak at 2019 Convergence

    RAPS’ 2019 Regulatory Convergence in Philadelphia will include a session hosted by the Canadian Association of Professionals in Regulatory Affairs (CAPRA). RAPS and CAPRA enjoy a collegial relationship and have collaborated on a number of initiatives in recent years. RAPS is even offering CAPRA members the opportunity to attend this year’s Convergence at the RAPS member rate. This is the second consecutive year CAPRA has hosted a session within RAPS’ signature annua...
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    EC Offers Two New Guidance Documents on MDR/IVDR

    The European Commission (EC) on Monday released one new guidance on persons responsible for regulatory compliance under the Medical Device Regulation (MDR) and the in vitro Diagnostic Device Regulation (IVDR), and another guidance on the implant card required by MDR. Under Article 15 of MDR and IVDR, companies are required to have at least one employee responsible for regulatory compliance with a degree in law, medicine, pharmacy, engineering or another relevant scien...
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    7 Things Attendees Love About the Regulatory Convergence

    RAPS’ signature annual event, the Regulatory Convergence , is a unique opportunity for the regulatory community to gather, reconnect, examine important issues together and exchange ideas face-to-face in a setting completely dedicated to the profession. It is the largest annual conference anywhere in the world for regulatory professionals working in the healthcare product space. For many, it is the one event they prioritize above all others to attend each year. This year...
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    European Parliament Passes SPC Waiver in Landslide Vote

    The European Parliament on Wednesday voted through a proposal to allow manufacturing waivers to supplementary protection certificates (SPCs) by an overwhelming majority, with more than 75% of members voting in favor of the measure.   In the EU, SPCs extend the 20-year patent protection period for medicines by adding up to five additional years of market exclusivity to approved drugs and biologics. The additional exclusivity period is meant to compensate for the lapse b...
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    EMA Launches Operations in Amsterdam

    The European Medicines Agency (EMA) on Monday kicked off operations at its temporary premises at the Spark building in Amsterdam Sloterdijk after moving out of its Canary Wharf office in London on 1 March.   EMA says it is also working with Dutch authorities to finish readying its temporary premises ahead of 30 March, when the agency’s seat officially switches from London to Amsterdam.   “By Monday 18 March, when EMA will be settled in the Spark building, close to ...
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    EMA Expands Online Portal for Parallel Distribution Submissions

    The European Medicines Agency (EMA) on Monday announced that going forward, parallel distributors will be required to use its recently launched secure online portal, known as Iris, to manage and submit parallel distribution notifications.   Background   Parallel distribution, also known as re-exportation, is a process by which companies in the EU distribute centrally authorized medicines between member states, independent of their marketing authorization holder (...
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    235 Earn Regulatory Affairs Certification (RAC)

    A total of 235 individuals earned Regulatory Affairs Certification (RAC) during the most recent RAC exam period, RAPS announced today. The challenging RAC exams test essential knowledge of healthcare product regulations, critical thinking and analytical skills. To pass, exam takers must be able to demonstrate not only that they know the relevant regulations, but also how they apply in a variety of realistic scenarios. By passing, each of the 235 professionals now hold ...
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    EU Begins Transition to Electronic Product Information for Medicines

    The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agency (HMA) on Thursday launched a six-month public consultation on the draft key principles that will form the basis for creating electronic product information (ePI) for medicines in the EU. Derived from conversations with EMA, EC, HMA and various stakeholders, the draft key principles explain how ePI, which includes the package leaflet for patients and the summary of product...
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    European Commission Consults on Orphan Drug Applications

    The European Commission on Tuesday launched a targeted consultation to provide input on a revision of its guideline on the content and format of applications for orphan drug designation, as well as the transfer of designations between sponsors.   "The comments received will be taken into account by the European Commission in the finalization of the guideline on the format and content of application for designation as orphan medicinal products and on the transfer of des...
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    European Commission Focuses New Report on Pharma Competition Enforcement

    The European Commission (EC) on Monday released a report on pharmaceutical competition enforcement activities by the Commission and EU member states' national competition authorities from 2009 to 2017.   The 46-page report was put together in response to concerns voiced by the European Council and Parliament in 2016 and 2017 regarding anticompetitive practices within the pharmaceutical sector, such as tactics to delay generic competition, pay-for-delay arrangements...
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    European Commission Updates Q&A on Safety Features for Medicinal Products

    The European Commission recently released an updated document setting out nine new and one revised frequently asked questions and answers on the implementation of the rules on the safety features for medicinal products for human use. Building off a previous update in November , five of the new questions deal with general issues, like whether medicinal products can carry more than one batch number, or whether during the transitional period manufacturers located in the E...