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  • Regulatory NewsRegulatory News

    FDA reiterates support for semi-distributed tracing model under DSCSA

    The US Food and Drug Administration (FDA) recommends that trading partners use the semi-distributed model to trace drug products though the drug distribution chain because of this model’s flexibility and advantages over other data architecture models. The Drug Supply Chain Security Act (DSCSA) requires that trading partners have these systems in place by November 2023.   Connie Jung, acting associate director for policy and compliance in FDA’s Office of Drug Security, ...
  • Feature ArticlesFeature Articles

    China’s data localization‒centric policies and their impact on human research

    This article reviews Chinese laws governing healthcare data and genomic resources during 1998-2021 and their impact on clinical research in humans by pharmaceutical companies. Companies conducting such research must be vigilant about complying with the complex legal requirements governing the research and identifying potential risks and mitigation strategies for compliance. The analysis includes review of various legal requirements issued by the People’s Republic of China ...
  • RF Quarterly

    Regulatory update for SaMD and AI product approvals in China

    This article outlines the status of regulation for software as medical device (SaMD) in China, with particular focus on medical software using artificial intelligence (AI) technology. The market approval pathways are reviewed, and key sticking points discussed. Recent regulatory updates in this fast-moving area are presented, together with various product approval examples.   China’s medical software regulatory framework The term “medical device” is defined widely ...
  • RoundupsRoundups

    Asia-Pacific Roundup: Vietnam seeks mRNA tech transfer for local COVID vaccine production

    The Vietnamese health ministry has met with the World Health Organization (WHO) to discuss the transfer of the technology needed to manufacture mRNA vaccines in the country.   Vietnam received a shipment of 811,200 doses of the COVID-19 vaccine developed by AstraZeneca and the University of Oxford via the COVAX Facility at the start of last month. Around 900,000 people have now received a vaccine, but the supply of doses remains a constraint on the pace of the rollou...
  • RF Quarterly

    RF Quarterly, March 2021: Global clinical trials

    Welcome to the inaugural issue of RF Quarterly featuring original, thematically developed content by regulatory experts addressing key areas and emerging issues in the global regulatory landscape. RF Quarterly is a member-exclusive addition to the regular monthly  Regulatory Focus  feature articles and replaces the former quarterly article series. The theme for this issue is Global Clinical Trials.   Clinical trials are an essential component of pharmaceutical re...
  • RF Quarterly

    Initiating clinical trials in China: What foreign medtech companies need to do

    This article discusses numerous recent changes in the regulation of clinical trials in China and proposes that Chinese clinical trials for medical device and in vitro diagnostic device (IVD) products are an increasingly viable option for non-Chinese companies of all sizes. [Updated]*   China’s regulatory framework Most life sciences products, including medical devices and IVDs, sold in China are supervised by the National Medical Products Administration (NMPA).  The ...
  • Regulatory NewsRegulatory News

    Vaccine makers call for alternative study designs for COVID vaccines

    Regulators need to facilitate new ways of clinically validating COVID-19 vaccines now that effective shots are being given around the world, Thomas Triomphe, executive vice president of Sanofi Pasteur, testified at a joint meeting of the European Parliament’s Committee on Industry, Research and Energy (ITRE) and the Committee on the Environment, Public Health and Food Safety (ENVI).   With over a dozen vaccines authorized or approved around the world, a significant n...
  • Feature ArticlesFeature Articles

    February's Regulatory Focus: Global and regional harmonization and alignment

    Feature articles during February included a range of topics focused on harmonization and alignment across global and regional regulatory entities, including electronic submissions through the European Medicines Agency (EMA), tools for updating the EU In Vitro Diagnostic Regulation (EU IVDR) template, China’s new PAC regulation, Project Orbis and improving patients access to new therapies, as well as a report on medtech companies’ preparation for EU Medical Device Regulatio...
  • Regulatory NewsRegulatory News

    EMA releases guidance for COVID variant vaccine development

    The European Medicines Agency (EMA) has published a reflection paper laying out what data are needed to support approval of vaccines that protect against variants of SARS-CoV-2, the virus that causes COVID-19.   “[I]t is an urgent public health priority to define an expedited regulatory process for the adaptation of vaccines to protect against current or future variants,” wrote the agency in announcing the new guidance. The document comes less than 2 weeks after a vari...
  • Feature ArticlesFeature Articles

    China’s new PAC regulation: Closer alignment with global best practices

    This article is a summarized translation of the most recent regulation published by China’s National Medical Products Administration (NMPA) on postapproval changes (PACs). The author provides an overview of the regulation and its annexes for PACs and discusses their impact on manufacturing site change management, change classification determination and consultation, and reporting categories.   Introduction On 13 January 2020, the NMPA published an announcement on t...
  • Regulatory NewsRegulatory News

    GAO: COVID-19 vaccine production falls short of January 2021 goal

    The Operation Warp Speed (OWS) goal to produce 300 million COVID-19 vaccine doses by January 2021 was not met, according to a status report released by the US Government Accountability Office (GAO).   Companies with current emergency use authorizations (EUAs) for vaccines are contracted under the program to release a combined 200 million doses of their vaccines by the end of March 2021 but had released just 63.7 million doses (31.8%) as of 31 January 2021, the report n...
  • EMA plans guidance on adapting vaccines for COVID variants

    The European Medicines Agency (EMA) on Wednesday said it will soon issue guidance explaining its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus.   The announcement comes just a week after the US Food and Drug Administration (FDA) said it is working on its own guidance to address these and other new variants of the virus. (Woodcock: FDA plans guidance to address new COVID-19 variants , Regulatory Focus 5...