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  • Regulatory NewsRegulatory News

    MDCG explains how notified bodies can use MDSAP audit reports

    In a new guidance document, the European Commission’s Medical Device Coordination Group (MDCG) details how notified bodies can reference Medical Device Single Audit Program (MDSAP) audit reports when planning surveillance audits under the Medical Devices Regulation (MDR) or In Vitro Diagnostics Regulation (IVDR).   While MDSAP audit reports cannot be used to obviate the need for annual surveillance audits required under MDR/IVDR, MDCG says the reports can be used t...
  • Regulatory NewsRegulatory News

    Trump’s ‘Buy American’ order tasks FDA on essential drugs and devices

    President Donald Trump on Thursday signed an executive order aimed at onshoring the production of essential drugs, medical devices and critical inputs for those products to reduce US reliance on foreign manufacturing and promoting federal procurement of domestic goods.   Speaking at a Whirlpool Corporation manufacturing plant in Clyde, Ohio, Trump said the US is too dependent on foreign medicines and supplies. “As we’ve seen in this pandemic, the United States must pro...
  • Regulatory NewsRegulatory News

    EC floats cross-sector health innovation partnership

    In a draft document issued 29 July, the European Commission (EC) unveiled its plan for integration of health technology capabilities across the European Union (EU). The plan was lauded by five pharmaceutical and medical technology associations who signed on to a joint statement welcoming the proposal.   Dubbed the Partnership for Health Innovation, the initiative aims to facilitate translational work by creating an EU-wide “health research and innovation ecosystem,” to...
  • ReconRecon

    Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Generic drug approvals still winning the pandemic at US FDA ( Pink Sheet ) BARDA Begins Stockpiling APIs For Critical Drugs ( Pink Sheet ) Report: GoodRx files for IPO ( MedCity News ) CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis ( Global Genes ) BARDA drafts Fujifilm Diosynth into its vaccine production effort, of...
  • ReconRecon

    Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar

    ​Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC ( Pink Sheet ) J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? ( Endpoints ) Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA ( Global Genes ) Kymera Therapeutics, fresh ...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on multiple function device products

    A finalized guidance gives direction for sponsors on US Food and Drug Administration (FDA) review of medical products that contain both medical and non-medical functions.   The guidance addresses provisions of the 21 st Century Cures Act ( Cures Act) that excluded some software functions from being considered medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The new document follows an April 2018 draft guidance and clarifies just how – an...
  • Regulatory NewsRegulatory News

    EMA: Thumbs up for 11, down for 2 new medicines

    At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.   Dapirivine Vaginal Ring is meant to reduce the risk of infection with HIV, in situations where oral pre-exposure prophylaxis is not used, ...
  • Regulatory NewsRegulatory News

    FDA exempts additional Class II devices from 510(k) requirements

    The US Food and Drug Administration (FDA) on Tuesday finalized an order to exempt five types of Class II medical devices from 510(k) requirements, which the agency says will decrease regulatory burdens on industry for makers of those devices.   Under the 21 st Century Cures Act , FDA was instructed to publish lists of Class I and Class II devices it would exempt from 510(k) requirements at least once every five years. In 2017, FDA exempted more than 70 Class I device...
  • Regulatory NewsRegulatory News

    FDA issues enforcement policy for coronavirus transport media

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective guidance to boost the availability of transport media intended to be used to transport clinical specimens for SARS-CoV-2 assays during the coronavirus disease (COVID-19) pandemic.   The guidance applies to transport media for both molecular and antigen diagnostic tests and covers Class I transport media devices falling under seven different product codes: JSG, JSM, JSL, JSN, LIO, JTW ...
  • Regulatory NewsRegulatory News

    New EMA pharmaceutical water quality guideline takes effect February 2021

    The European Medicines Agency (EMA) on Monday issued a new guideline on the quality of water for pharmaceutical use that will replace its nearly two-decades-old guidance and position statement on water quality when it takes effect in February 2021.   The adoption of the guideline follows a public consultation that kicked off in November 2018, with EMA making mostly minor changes to the guideline aside from revisions to the table listing minimum acceptable quality o...
  • Regulatory NewsRegulatory News

    Updates on MDR implementation, transparency; MDCG posts CEAR template

    The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices under the regulation.   The Commission’s Medical Devices Coordination Group (MDCG) also released a template for clinical evaluation assessment reports (CEAR) for notified bodies to document their assessments of clinical evidence for medic...
  • Feature ArticlesFeature Articles

    Regulation of advanced therapy medicinal products in the EU

    This article explains some of the terminology relating to advanced therapy medicinal products (ATMPs), including gene and cell-based therapies, tissue-engineered products, and combined ATMPs. The author explains the key EU regulations and guidance documents for each therapy type and discusses marketing authorization, accelerated regulatory pathways, and market access. He advises companies navigating this complex regulatory environment to engage with the regulatory agencies...