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    RAPS and Industry Experts Join Forces for Dedicated MDR Workshop

    • 18 May 2017
    • By
    RAPS is bringing together a panel of Europe’s top industry experts to deliver a dedicated workshop on the new EU regulations for medical devices and in vitro diagnostic devices. ‘ EU Regulatory Essentials, Medical Device and In Vitro Diagnostics: Transitioning from Current Directives to New Regulations ’ will take place on 4 and 5 July in Brussels and will introduce and explain the new EU regulations. Offered for the first time in Europe, the workshop will also...
  • Regulatory NewsRegulatory News

    Petition to FDA Seeks to Modify Trial Regulations Following Deaths

    A petition submitted to the US Food and Drug Administration (FDA) in 2016 has been updated recently, as it seeks to reform FDA requirements for investigational new drug (IND) applications, investigational device exemptions (IDEs) and new drug applications (NDAs). In a letter submitted in April, the Center for Responsible Science noted 19 treatment-related deaths in clinical trials from July 2016 through April 2017. Among those were five clinical trial participants w...
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    Final EU MDR, IVDR Texts Published, Countdown to Implementation Begins

    The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published on Friday in the Official Journal of the European Union , setting in motion the timeline for implementation of the new regulations to commence on 25 May. Gert Bos, executive director at Qserve Group and a RAPS board member, explained to attendees of the MedCon conference in Cincinnati on Thursday some of the difficulties that industries will face over the ...
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    Generic Drug Industry Group Seeks FDA Regulation Changes

    The Association of Accessible Medicines (AAM), formerly known as the Generic Pharmaceutical Association, has recommended five major US Food and Drug Administration (FDA) regulation tweaks in a letter to the Department of Commerce. In addition to citing a lack of clarity in the regulations governing the permitting processes of large life sciences projects, David Gaugh, SVP for sciences and regulatory affairs at AAM, called for five actions to reduce the regulatory bu...
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    MHRA Plans for the Future of Drug, Device Regulation Post-Brexit

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday released a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU. MHRA is pushing for a more international strategy that focuses on collaboration and engagement with key partners and stakeholders and continuing to partici...
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    Asia Regulatory Roundup: India Looks to Reform Drug Pricing Legislation (18 April 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Forms Leadership Group to Reform Drug Pricing Legislation, NPPA India has convened a committee to consider reforms to drug pricing legislation and the agency that enforces the rules. Officials at the Department of Pharmaceuticals took the step in response to feedback from regulators and industry about the shortcomings of the existing pricing legislation and mech...
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    Democrats Propose Wide-Ranging Bill to Lower Drug Costs

    More than a dozen House and Senate Democrats late Wednesday unveiled a host of new provisions to bring down the rising cost of pharmaceuticals, offering up many ideas that have been publicly opposed by the pharmaceutical industry. The bill, known as the Improving Access to Affordable Prescription Drugs Act , was introduced alongside a House companion , though neither is likely to gain much traction in the Republican-controlled House and Senate. However, some of the b...
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    Canada to Require Drugmakers to Publicly Disclose Drug Shortages

    Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca. “As soon as a market authorization holder knows that it will take longer than 20 days to supply a drug to meet expected patient volumes on an ongoing basis, they will report this as a...
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    Trump Working on ‘New System’ to Increase Drug Competition

    President Donald Trump tweeted Tuesday morning that he’s “working on a new system where there will be competition in the Drug Industry,” though how such a system would work alongside the current generic drug and biosimilar competitors, remains to be understood. On what such a system might entail, a White House spokesman told Focus : "The President has been steadfast in his commitment to reducing the regulatory burden on everyday Americans. As demonstrated through the ...
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    Trump Criticizes ‘Slow and Burdensome’ FDA Approval Process

    In a joint session of Congress on Tuesday evening, President Donald Trump repeated his attacks on the US Food and Drug Administration’s (FDA) “slow and burdensome approval process,” promising to “slash the restraints, not just at FDA but across our government.” The speech, widely regarded as a positive step away from his more off-the-cuff rallying cries, pointed to Megan Crowley, who was in attendance in the Capitol and is diagnosed with a rare condition known as Po...
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    Trump Targets Regulations Again With New Executive Order

    President Donald Trump on Friday took another swipe at federal regulations, signing an executive order that requires all federal agencies to create task forces to help “alleviate unnecessary regulatory burdens placed on the American people.” The added layer of bureaucracy created by the executive order is called upon to, within two months, designate an agency official as its Regulatory Reform Officer (RRO). Each RRO shall oversee the implementation of regulatory reform ...
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    Asia Regulatory Roundup: India Adopts New Medical Device Regulations (7 February 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Medical Device Rules, Marking Long-Sought Split From Drug Regulation India has finalized its long-awaited medical device rules. The legislation is set to ease regulation of medical device manufacturing and development by freeing the industry from rules designed for the pharmaceutical sector. Until now, a lack of dedicated regulations covering the majori...