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  • Regulatory NewsRegulatory News

    EC Publishes New Guidelines on Good Clinical Practices for ATMPs

    Thanks to a 2007 regulation on advanced therapy medicinal products (ATMPs), the European Commission (EC) on Wednesday released new guidelines on the good clinical practice (GCP) requirements for these complex and innovative products that can include gene and cell therapies. The 15-page guidelines discuss clinical trial design, non-clinical studies, quality of the investigational ATMPs, the safe conduct of the clinical trial, upstream interventions on subjects and admini...
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    APEC Members See Increased Regulatory Convergence

    Countries involved in the Asia-Pacific Economic Cooperation (APEC) are better aligning their regulatory schemes related to drugs and medical devices, according to a new survey unveiled Monday at an APEC meeting in Chile. The survey shows how between 2008 and 2019, APEC countries are seeing modest increases in: Sharing information (from 16 APEC economies to 19 economies) Establishing confidentiality commitments (from 12 economies to 15) Sharing good manufacturing pr...
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    EU Device Industry Groups Call to Accelerate MDR Implementation

    With the EU’s new medical device regulation (MDR) coming into effect in less than a year, seven EU-based medical device industry groups on Wednesday called to accelerate the implementation of the regulation “to avoid severe disruption of product supply to patients and hospitals.” While acknowledging a mechanism in MDR to allow for a grace period for certain devices that must meet the 26 May 2020 deadline, the groups explain why that mechanism has two fundamental weaknes...
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    New Law to Boost EU-level Cooperation on Health Tech Assessments

    In a boost for health technology assessments (HTA), the European Parliament recently adopted a new law that allows for greater cooperation among EU member states.   The law on HTAs specifically seeks to minimize duplicate assessments on new medicines and medical devices with the goal of removing unnecessary barriers to patient access and reducing administrative burden on industry. Following its 3 October adoption , the law was well-received by MedTech Europe as ...
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    Perspective: Regulatory Bill Could be Dangerous for FDA, Public Health

    A bill making its way through Congress could end up having "potentially disastrous consequences" for the US Food and Drug Administration (FDA) and public health, professors from the Program on Regulation, Therapeutics, and Law at Harvard Medical School and the Georgia State University College of Law, wrote in the New England Journal of Medicine this week. The bill, known as the Regulatory Accountability Act , has been promoted as a way to decrease burdensome regul...
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    Major Deregulation? FDA Withdraws Several Rules and Regulations Related to Medical Products

    Almost a year ago, President Donald Trump told pharmaceutical executives that his administration would cut 75% to 80% of FDA regulations, "at a level no one has ever seen before." Since those comments last January , the US Food and Drug Administration (FDA) has withdrawn the most rulemakings of any Department of Health and Human Services (HHS) agency, though only a handful are related to medical products (the others are tobacco related) and it's unclear how the wi...
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    First Implementing Act Under EU MDR, IVDR Open for Consultation

    The first implementing act for the EU’s new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) is open for comments until next Wednesday. Implementing acts allow the commission to tease out the intricacies of the legislation and this first one is related to the Notified Body product codes for medical devices and IVDs. The codes, included in the implementing regulation's annexes, are used to categorize the fields of expertise of the NBs ...
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    New E&Y MedTech Report Highlights Growth, Regulatory Questions

    Ernst & Young on Monday released a new report on how the global medical technology (medtech) industry grew by 5% in 2016, with US and EU medtech companies seeing net income increase 17%, though several regulatory and legislative question marks are on the horizon. In addition to the improvements seen in income and revenue growth in 2016 when compared to 2015, the report also shows that overall, US and European medtech financing increased 101% in 2016, to $43.9 billi...
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    FDA Wants to Know What Regulations and Paperwork Requirements Need to Go

    As part of work under two executive orders, the US Food and Drug Administration's (FDA) centers on Thursday sought comments on which existing regulations and related paperwork requirements could be modified, repealed or replaced, to reduce the burden on industry while allowing FDA to continue its public health mission and fulfill statutory obligations. Back in February, when President Donald Trump first announced his order to reduce regulatory burdens, several exper...
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    IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018

    The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018. According to a summary of the 5th meeting of the IGDRP in Ottawa in June, the IPRF management committee and the IGDRP steering committee expressed support for the consolidation of the IPRF and IGDRP initiatives in order to best respond to ...
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    MHRA Offers Interactive Guide on New EU Device, IVD Regulations

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released an introductory guide to help medical device manufacturers understand their obligations under the new EU regulations for medical devices (MDR) and in vitro diagnostic devices (IVDR). With the three- (for MDR) and five-year (IVDR) transition periods now underway, the new regulations will apply across EU member states from 26 May 2020 and 2022, respectively. During the transiti...
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    Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Seeks Feedback on Proposed Alignment of Australian and European Medical Device Rules The Therapeutic Goods Administration (TGA) of Australia is proposing to align parts of its medical device regulatory requirements with those in place in Europe. TGA is gathering feedback on plans to reclassify surgical mesh and place new requirements on manufacturers of implants wi...