• Regulatory NewsRegulatory News

    Prompted by recent recalls, regulators scramble to address novel nitrosamines

    Updated 3 November 2022* The discovery of novel nitrosamine impurities in pharmaceuticals, coming after the valsartan/nitrosamine crisis of 2018, has caught global regulators and industry by surprise as more products than anticipated are affected by these impurities.   The situation raises new questions about how to set daily acceptable intake limits for pharmaceutical products when toxicological data on these impurities is scarce.   These novel nitrosamines, ...
  • Regulatory NewsRegulatory News

    CHMP recommends 12 new medicines, including first RSV treatment for infants

    The European Medicine Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) last week endorsed 12 new medicines for authorization, including the first treatment to prevent respiratory syncytial virus (RSV) in newborns, driving the total number of endorsed treatments to 70 since the beginning of the year. Five of the 12 approval recommendations are for orphan drugs.   The new RSV treatment, Beyfortus (nirsevimab) developed by AstraZeneca and Sanofi, was s...
  • Regulatory NewsRegulatory News

    Convergence: EU official says no delay to CTIS implementation, despite industry concerns

    PHOENIX, AZ – Country-specific requirements that diverge from the Clinical Trials Regulation (CTR) and the lack of a forum for resolving issues with the Clinical Trial Information System (CTIS) portal were among the key issues industry representatives brought to a session at RAPS Convergence 2022.   Another problem is that the portal does not flag or send information to sponsors when new information is received, so sponsors must check frequently for updates.   In t...
  • Regulatory NewsRegulatory News

    EMA reports steady rise in clinical trial applications registered in CTIS portal

    Nearly 195 clinical trial applications (CTAs) have been submitted to the European Medicine Agency’s (EMA) Clinical Trial Information System (CTIS) portal through July, marking a substantial increase from a month earlier, according to a 23 August report from the agency.   However, during the same period, most applications (224) were still being registered in the older EudraCT database. (RELATED: EMA reports slow uptick in clinical trial applications submitted via CT...
  • Regulatory NewsRegulatory News

    EMA reports slow uptick in clinical trial applications submitted via CTIS portal

    The number of applications filed through the Clinical Trial Information System (CTIS) portal continues to grow, even while most applications are still being filed in the current EudraCT system, according to a 28 July report from the European Medicines Agency (EMA).  Stakeholders offered a mixed assessment of their user experience at recent forum.   Starting in January 2023, CTIS will replace the EudraCT portal and clinical trial sponsors must use the CTIS portal to a...
  • Regulatory NewsRegulatory News

    EMA to address nitrosamine impurities in upcoming revision of active substances guidance

    The European Medicines Agency (EMA) will be updating its guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients (APIs), the agency announced in a new concept paper .   The revised guideline is meant to address risk factors for formation of nitrosamines in medicinal products and strategies for preventing their formation and presence.   EMA and other regulators have ...
  • RF Quarterly

    RF Quarterly, June 22: Regulatory history

    Welcome to the June issue of RF Quarterly in which global regulatory experts write about Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), medical device regulations in China’s National Medical Products Administration (NMPA), and a personal reflection on 3 decades at the International Council for Harmonisation (ICH). Also included are articles on the development of clinical trial disclosure requirements, expedited pathways, and the De Novo pathway and the Final Ru...
  • Regulatory NewsRegulatory News

    EMA to explore reviewing raw data from clinical trials in applications

    The European Medicines Agency (EMA) is looking for industry participants for a pilot assessing whether reviewing raw clinical trial data improves its evaluation of marketing authorization applications (MAAs) for new medicines and post-authorization applications.   The pilot , announced on 12 July, stems from a joint workplan announced by EMA and the EU’s Heads of Medicines Agencies (HMA) to address issues related to big data in healthcare and medicines development. On...
  • RF Quarterly

    Evolution of the Japanese regulatory system and agencies

    The Japanese regulatory system has been recognized as one of the most sophisticated and stringent regulatory systems in the world. The regulatory policies are developed and administered by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) executes the policies, and certain authorities are delegated to local governments. Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the...
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    Official encourages ATMP sponsors to consult toolbox guidance to avoid PRIME derailments

    An EU official advised manufacturers of advanced therapy medicinal products (ATMPs) to consult the European Medicines Agency’s (EMA) recently issued “toolbox” guidance to avoid having products rejected from being eligible for accelerated review under the PRIME program for quality-related deficiencies.   Barbara Bonamassa, a reviewer with the Italian Medicines Agency (AIFA), offered an update on some of the EU’s ongoing activities to expedite the development of ATMP the...
  • ReconRecon

    Recon: FDA staff find Pfizer, Moderna vaccines safe for children; Rune Labs gets clearance to track Parkinson’s symptoms with Apple Watch

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer COVID vaccines safe and effective for small children, FDA staff say ( Reuters ) ( NYTimes ) U.S. FDA staff says Moderna COVID vaccine effective and safe for children ( Reuters ) ( Politico ) FDA requires disclosure of suicide risk for anti-baldness drug ( Reuters ) Rune Labs gets FDA clearance to use Apple Watch to track Parkinson's symptoms ( Reuters )...
  • Regulatory NewsRegulatory News

    FDA and EMA mostly align on GCP inspection deficiencies, study finds

    A study conducted by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) found that the agencies are identifying the same types of deficiencies in joint good clinical practice (GCP) inspections with respect to protocol compliance, documentation deviations, and human subject protections.   The paper follows a mutual transatlantic cooperation on GCPs between the regulators that went into effect on 1 September 2009. Under the program, regulators ...