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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...
  • RoundupsRoundups

    Asia Regulatory Roundup: Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Hong Kong Proposes Regulatory Framework for Cell and Gene Therapies   Hong Kong has proposed legislation to create a regulatory framework for advanced therapy products (ATPs), such as interventions based on cells, genes and tissues. The plan is to amend existing laws to create licensing, labeling and record-keeping requirements for ATPs.   Work to update the law ...
  • RoundupsRoundups

    Asia Regulatory Roundup: TGA Adopts Risk-Based Model for Fecal Microbiota Transplants

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   TGA Adopts Risk-Based Model for Fecal Microbiota Transplants   Australia’s Therapeutic Goods Administration (TGA) has adopted a risk-based approach to the regulation of fecal microbiota transplants (FMT). TGA decided to treat FMT products as anything from Class 1 biologicals to Class 4 medicines after running a public consultation earlier in the year.   The model...
  • RoundupsRoundups

    Asia Regulatory Roundup: Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   Australia Aligns Sartan Rules to EMA as Singapore Finds NDMA in Ranitidine Drugs   Australia’s Therapeutic Goods Administration (TGA) has aligned its requirements for sartan medicines with those adopted in Europe. The action coincided with news from Singapore about the presence of N-nitrosodimethylamine (NDMA), one of the key sartan impurities, in GlaxoSmithKline’s Z...
  • RoundupsRoundups

    Asia Regulatory Roundup: China Changes Stance on Fake Drugs and Online Sales in Legal Update

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.   China Changes Stance on Fake Drugs and Online Sales in Legal Update   China has passed changes to the drug administration law. The revised law, which will come into force at the start of December, requires online sellers of drugs to comply with certain rules and increases the maximum fine for organizations that make and market counterfeit medicines.   The Nationa...
  • RoundupsRoundups
    Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China Expands Medical Device Registration Pilot to Cover Multiple Regions

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Expands Medical Device Registration Pilot to Cover Multiple Regions   China’s National Medical Products Administration (NMPA) has expanded a medical device registration pilot project. The pilot project, which began in a free trade zone, will now cover 21 provinces to help NMPA accrue more experience of the medical device registration system.   NMPA is running ...
  • Regulatory NewsRegulatory News

    China’s NMPA Cites Overseas Device, IVD Companies

    China’s National Medical Products Administration (NMPA) published overseas inspection results in late January, highlighting 17 overseas medical device and IVD manufacturers that were cited, including BD and Boston Scientific.   Since November 2017, when NMPA began to publish overseas inspection results, a total of 41 manufacturers have been cited, according to ChinaMed Device, LLC, which is a medical device and IVD consulting firm based in Boston, and is a certified NM...