China regulator tightens guideline on biological products, including vaccines

FILE PHOTO: Vials labelled “COVID-19 Coronavirus Vaccine” are placed on dry ice in this illustration taken, December 5, 2020. REUTERS/Dado Ruvic/Illustration

BEIJING (Reuters) – China’s market regulator said on Monday it had tightened up a guideline for inspection of biological products, including vaccines, before a batch is sold or imported.

The new guideline, effective from March 1 next year, adds a requirement that provincial-level medical product regulators are responsible for investigating major flaws that could impact product quality in companies’ manufacturing process in their region, State Administration For Market Regulation said on its website.

The new guideline also specifies situations where inspection of pre-sale or pre-imported batches of such products could be waived, SAMR said.

China has allowed vaccines, if they are used to cope with infectious disease epidemics or other emergencies, to be exempted from inspection procedures, known as lot release, after approval from State Council’s medical product regulating department.

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