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 regulates 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.