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  • Regulatory NewsRegulatory News

    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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    EU Takes Another Step Towards Adopting SPC Waiver Proposal

    The European Union’s proposal to allow manufacturing waivers to supplementary protection certificates (SPC) is one step closer to adoption after EU ambassadors endorsed a compromise reached on 14 February with the European Parliament during a meeting of the Committee of the Permanent Representatives (Coreper) on Wednesday.   Now that the draft regulation has been agreed to, it will undergo a legal and linguistic review before being sent to the European Parliament and C...
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    EU Advances SPC Waiver Proposal

    The European Union's proposal to allow manufacturing waivers to supplementary protection certificates (SPC) took a step forward on Wednesday after EU ambassadors backed the EU Council's position on the proposed regulation during a meeting of the Committee of the Permanent Representatives (Coreper).   "The draft regulation is expected to remove the competitive disadvantages faced by EU-based manufacturers of generics and biosimilars vis-à-vis manufacturers established o...
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    Generic and Branded Industry Groups Spar Over EU SPC Waiver Proposal

    The European Parliament’s International Trade Committee (INTA) on Monday voted to adopt a draft opinion supporting changes to an amendment that would allow for manufacturing waivers to supplementary protection certificates (SPCs).   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 be...
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    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
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    US Trade Report Highlights Pharma's IP, Counterfeit Issues Abroad

    The Office of the United States Trade Representative's (USTR) 2017 report on the state of intellectual property (IP) protection and enforcement in US trading partners around the world offers a look into concerns regarding market access barriers, particularly for those in the pharmaceutical and medical device industries. The report offers numerous examples of issues pharmaceutical and device companies deal with in some foreign countries, noting that these IP-intensi...
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    European Regulatory Roundup: EMA’s PRAC Seeks to Suspend Four Imaging Agents (16 March 2017)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. PRAC Asks to Suspend Authorizations of Four Imaging Agents After Reviewing Safety The Pharmacovigilance and Risk Assessment Committee (PRAC) has recommended the suspension of the marketing authorizations for four linear gadolinium contrast agents. PRAC put forward the proposal after finding “convincing evidence” accumulations of gadolinium are present in the brain many month...
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    Liquid-Proof Surgical Gowns? Now FDA Wants Companies to Prove It

    The US Food and Drug Administration (FDA) on Tuesday offered final guidance for companies that will have to conduct performance testing to support claims that their surgical gowns can keep out liquids and submit a 510(k) application within 60 days to the agency to prove those claims. Background In 2000, FDA issued a final rule clarifying the difference between gowns worn by health care personnel and surgical apparel worn by operating room personnel during procedures whe...
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    RAPS-National University of Singapore Certificate Program Celebrates First Graduating Class

    The Medical Device Regulatory Affairs (MDRA) Graduate Certificate Program , a joint academic program from RAPS and the School of Biomedical Engineering at the National University of Singapore (NUS), graduated its first cohort of 31 students last month. The program was developed in partnership with several of Singapore’s government agencies as part of the country’s efforts to nurture a highly competent regulatory workforce. Singapore has spent much of the past de...
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    RAPS, National University of Singapore Gear up for 2nd Year of Certificate Program

    Last year, RAPS and the National University of Singapore (NUS) launched a joint graduate certificate program in Medical Devices Regulatory Affairs (MDRA) for Singapore-based regulatory professionals. The program was developed in partnership with Singapore’s government as part of its effort to help cultivate the highly competent regulatory workforce needed to support the country’s growing medical technology industry. The first year of the MDRA certificate program ...
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    EU Personal Data Protection Reforms Move Forward

    After three years of deliberation, the European Council has agreed on its approach to data protection reform, allowing the council to initiate a trilogue with the European Parliament and Commission. Background The current rules governing data protection in the EU were adopted in 1995 under Directive 95/46/EC . However, there have been massive changes in how data is generated and used in the 20 years since the directive was adopted. In 1995, few Europeans had Internet...
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    Biologics Exclusivity Still Central in Trade Talk Debate

    The length of data exclusivity for biologics remains one of the most controversial aspects of the Trans-Pacific Partnership (TPP), which is poised to be the largest free-trade deal in history. While the US Trade Representative (USTR) and the biopharmaceutical industry have publicly called for a 12-year exclusivity period, Politico reports that some industry lobbyists are tempering their expectations. Background Among the 12 parties to TPP, the United States is the on...