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China’s market regulator tightens biological products guidelines, including shipments of vaccines 

China’s market regulator tightens biological products guidelines, including shipments of vaccines 
China’s State Administration for Market Regulation (SAMR) has announced that the country will be increasing inspection requirements on biological products, including vaccines, before they can be exported from or imported.

The SAMR is responsible for comprehensive market regulation in the country, drafting and monitoring laws and rules to ensure quality food, power, and standardization strategy. On its website, the organization stated that the guidelines will come into effect on March 1, 2021, adding new measures that require individuals at the provincial level to investigate any potential flaws in product quality in the manufacturing process.

With China having five Covid-19 vaccines in the final phases of state approval, any limitations on the ability for countries to access these vaccines could severely impact the global response to the pandemic. A final date for when all of the Chinese vaccines will be ready for distribution is not yet known. However, the guidelines do include a provision which will allow the SAMR to waive those restrictions for infectious disease epidemics or other emergencies.

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The new measures from the SAMR were announced shortly after China passed the Export Control Law of the People’s Republic of China which, once it has come into effect, will establish a framework for restricting exports of military products or biological, chemical, missile, or nuclear technology. The law is designed to allow Beijing to have better coordination over goods that are leaving the country, ensuring that they maintain a list of importers, expand regulation over, and include licensing of, goods.

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