Regulatory Open Forum

 View Only

China drafts new vaccine standards

  • 1.  China drafts new vaccine standards

    Posted 05-Mar-2019 17:03

    Seeking to codify higher standards for the production, transportation, and storage of vaccines, Chinese authorities in January drafted a draft Vaccine Administration Law that would tighten restrictions on vaccines.

    Under the draft law, companies, firms or non-profit organizations are subject to government authorization to market a specific vaccine and are prohibited from having others produce vaccines on its behalf.

    The law also establishes a national system for inspecting vaccines, and for tracing the production, transportation, storage and use of vaccines, and closely <g class="gr_ gr_30 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar multiReplace" id="30" data-gr-id="30">regulates</g> how clinical trials are conducted. It expressly prohibits making infants and young children the subjects of clinical trials. Vaccine manufacturers are also required to buy liability insurance.


    About Pacific Bridge Medical
    Pacific Bridge Medical (PBM) was founded in 1988 to help international medical companies solve their most complex problems while doing business in Asia. Since then, PBM has assisted hundreds of healthcare companies with business development and regulatory issues in Asia. We provide our services to all types of medical firms, including medical device, IVD, pharmaceutical, and API.

    ------------------------------
    Ames Gross
    President
    Pacific Bridge Medical
    Bethesda, MD
    www.pacificbridgemedical.com
    contact@pacificbridgemedical.com
    ------------------------------