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  • Feature ArticlesFeature Articles

    Regulatory Focus, August issue: Global clinical trials, clinical trial applications

    Feature articles during August focused on global clinical trials and clinical trial applications, with articles on regulatory options for conducting clinical trials in China, a case study on the impact of COVID-19 on submissions to European authorities, and an examination of Canada’s application process and alternate pathway for COVID-19‒related trials. Also included was an article on US Food and Drug Administration (FDA) updates on requirement for EUAs for diagnostics sup...
  • Regulatory NewsRegulatory News

    ICH updates: E14 consultation, Health Canada implements M9 guideline

    The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the docum...
  • ReconRecon

    Recon: Drugmakers counter Trump's pricing plan; Teva indicted by US DOJ on price-fixing charges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers deliver counteroffer to Trump international pricing plan ( Politico ) Does Purdue’s Reformulated OxyContin ER Really Deter Abuse? US FDA Panel To Decide ( Pink Sheet ) Eric Topol Criticizes FDA's Exaggeration Of Plasma's Efficacy In COVID-19 Treatment ( NPR ) Trump Again Claims He’s Bringing Down Drug Prices, But Details of How Are Skimpy ( KHN ) O...
  • Regulatory NewsRegulatory News

    European Commission sets common specifications for reprocessing single-use devices

    The European Commission this week issued regulations establishing common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR).   Under MDR, single-use devices may be reprocessed where permitted by national law. Member states may also determine what rules they will apply to single-use devices reprocessed and used within a health institution, so long as the reprocessing is performed in accordance with the common sp...
  • Regulatory NewsRegulatory News

    EMA goes all-virtual for remainder of 2020

    The European Medicines Agency (EMA) has announced that all its committee and working party meetings will be held virtually through the end of 2020.  Stakeholder events will also be virtual through the end of the year as well, although a few events will have an in-person speaker panel.   “EMA has taken steps to reduce the further spread of COVID-19, with the aim of protecting staff, delegates and experts and playing our part as responsible citizens in our host country, ...
  • Regulatory NewsRegulatory News

    Eudamed actor registration module set to launch in December

    In a position paper released Tuesday, the European Commission’s Medical Device Coordination Group (MDCG) confirmed that the Eudamed actor registration module will be deployed on 1 December 2020.   The module was previously expected in May, but its deployment was pushed back by the Commission just before its launch date to reflect the postponed date of application of Eudamed. At the time, the Commission said it would pursue a phased rollout of the six Eudamed modules ...
  • Regulatory NewsRegulatory News

    European Commission reviews impact of orphan, pediatric regulations

    The European Commission on Tuesday published the results of a yearslong evaluation of the EU’s orphan and pediatric medicines regulations it says will be used to guide future legislative changes and shape the EU pharmaceutical strategy.   The more than 100-page evaluation reviews the positive impacts and shortcomings of the orphan regulation, Regulation (EC) No 141/2000 , and the pediatric regulation, Regulation (EC) No 1901/2006 , based on external studies and var...
  • 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

    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

    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, ...