RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • 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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 Since those comments last January , the US Food and Drug Administration (FDA) has withdrawn the most rulemakings of any Department of Health and Human Services (HHS) agency, though only a handful are related to medical products (the others are tobacco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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • RAPS' LatestRAPS' Latest

    6 Things You Need to Do to Prepare for the New EU Medical Devices Regulation

    When the EU’s new Medical Devices Regulation ( MDR ) entered into force last month, it set in motion a three-year countdown to the new rules’ full application in 2020. For companies marketing devices in the EU that wish to continue to do so, there is a lot to do in that relatively short time, so it is critical to begin as soon as possible. Early preparation is key. Following are six things you should be doing to get ready. 1. Plan Ahead In order to figure out wh...
  • Regulatory NewsRegulatory News

    EMA Offers Draft Guideline on Serious Breaches of Clinical Trial Regulations

    The European Medicines Agency (EMA) on Tuesday opened for public consultation a draft guideline on serious breaches of clinical trial regulations or clinical trial protocols. The agency says the guideline is intended to "outline the practical arrangements for notification of serious breaches … provide advice on what should and what should not be classified as a serious breach and what must be reported … [and] To outline possible actions that may be taken by the EU/...