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  • Regulatory NewsRegulatory News

    New reports address generics pricing, innovation in the EU

    A European generics trade association is calling for relaxation of “extreme cost containment policies” against generic medicines, asserting that such measures are counterproductive and may endanger the supply chain through consolidation of production and withdrawal or products from the market.   “The European Commission has collected a growing body of evidence showing that extreme cost containment policies applied to generic medicines are counterproductive, driving ind...
  • Regulatory NewsRegulatory News

    EU official says ICH Q6B is outdated and needs revision

    The International Council for Harmonization’s (ICH) Q6B guideline setting acceptance criteria for new biological products needs to be revised to incorporate a more patient-centric approach and to include the science and risk-based concepts embodied in other ICH guidelines, according to a regulator from the EU.   Mats Welin, a senior expert for vaccines and monoclonal antibodies (MAbs) for the Swedish Medical Products Agency, made this assertion at the 30 November webi...
  • ReconRecon

    Recon: Blueprint's $250M preclinical buy; WHO, CDC, Biden react to Omicron variant

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden says omicron variant is cause for concern but not panic ( NPR ) CDC Statement on B.1.1.529 (Omicron variant) ( CDC ) Pfizer boosts Paxlovid manufacturing capacity as Merck’s rival COVID pill hits surprise efficacy setback ( Fierce ) Opinion: Becerra needs to open up to the press ( AHCJ ) Opinion: Will Moderna Ever Learn to Share? ( MedPage Today ) Who ...
  • Feature ArticlesFeature Articles

    Global pediatric development: Challenges, potential solutions, and opportunities

    The US and EU require sponsors to evaluate their drugs for use in children. The low prevalence of many conditions in children means sponsors commonly want to conduct one pediatric development program that satisfies the requirements of both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA). However, multiregional pediatric development is challenging. This article will describe some of the challenges associated with pediatric development, offer po...
  • Regulatory NewsRegulatory News

    Improving transparency of regulatory data at EMA, Health Canada, FDA

    Over the last decade, the European Medicines Agency (EMA), US Food and Drug Administration (FDA) and Health Canada (HC) have gotten better at disclosing previously confidential clinical data, a study published in The Journal of Law, Medicine & Ethics has found.     However, each agency discloses this data in a variety of different ways, according to Alexander C. Egilman, with the Center for Outcomes Research and Evaluation at Yale–New Haven Hospital in New Haven, CT,...
  • Regulatory NewsRegulatory News

    Europe’s MDCG offers guidance on legacy medical devices, repackaging

    A new guidance document from the European Commission’s Medical Device Coordination Group (MDCG) spells out how the newly implemented Medical Device Regulation (MDR) will be applied to legacy devices and devices placed on the market prior to the 26 May 2021 MDR rollout.   In the guidance , MDCG takes the position that the MDR’s post-market surveillance, market surveillance, and vigilance requirements apply to legacy devices. The surveillance of legacy devices by notifi...
  • Regulatory NewsRegulatory News

    EMA's challenges through 2023: Global collaboration, supply shortages, antimicrobial resistance

    The European Medicines Agency (EMA) recently released its final programming document for 2021 to 2023, setting goals to address medicine availability and shortages, analysis and access to healthcare data, supply chain issues, and antimicrobial resistance.   Emer Cooke, EMA Executive Director, stated in the document’s foreword that much of the agency’s planning over the next few years will be accomplished by implementing the EMA Network Strategy and Regulatory Science S...
  • ReconRecon

    Recon: CureVac pulls back its COVID mRNA vax; Medtronic's new robotics bid

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency ( FDA ) FDA still without a permanent leader as clock ticks down on acting head ( CNN ) IPO floodgates open up after summer lull as five more biotechs file for Nasdaq ( Endpoints ) FDA staff doesn’t take stance on Moderna Covid booster shots, says two doses are...
  • Regulatory NewsRegulatory News

    EMA readies CTIS go-live plan

    A new electronic information system for clinical trial reporting in the EU is one step closer to launch with the European Medicines Agency’s (EMA’s) Thursday publication of a go-live planning document.   The 12-page document covers key steps remaining before the launch of the Clinical Trial Information System (CTIS), planned for 31 January 2022, and follows an April 2021 audit by EMA’s management board that confirmed that CTIS is “fully functional and meets the agreed ...
  • Regulatory NewsRegulatory News

    New MDCG guidance shows how devices fit into MDR’s classification rules

    The European Commission’s Medical Devices Coordinating Group (MDCG) on Monday issued a guidance to help manufacturers classify their devices under the Medical Device Regulations (MDR) before they are placed on the EU market.   Under the MDR , which went into effect on 26 May 2021, devices are divided into four classes: I, IIa, IIb and III. Devices are ranked according to risk from class I for the lowest-risk devices to class III for the highest.  Annex VIII of the...
  • Regulatory NewsRegulatory News

    New guide to clinical trial lay summaries available for EU sponsors

    The European Commission (EC) has laid out recommendations on best practices for preparation, translation and dissemination of lay summaries of clinical trial information, intended both for trial participants and the general public, in a newly published document.   The EC’s Clinical Trials Expert Group (CTEG) adopted the guidelines in July 2021; the 85-page document walks users through the lay summary (LS) process from the planning and scoping stage, through the develop...
  • Feature ArticlesFeature Articles

    Challenges and opportunities in medical device clinical trials in Europe

    In mid-2021, a survey was launched to evaluate where European medical device manufacturers and pharmaceutical companies see the greatest challenges in clinical trials and which trends they envision in this area in coming years. The top challenges included lack of personnel, time investments, complexity of the study protocol, the identification of suitable subjects, and data analysis and publication. Although most participants had not yet conducted decentralized trials, mor...