Similar to the restrictions provided under HGRAC Regulation, the Biosecurity Law confirms that foreign persons are generally prohibited from collecting or preserving HGR in China or providing HGR abroad. Foreign persons will have limited rights to acquire and/or use China’s HGR through scientific research activities conducted in collaboration with Chinese entities but only with the prior approval of China’s Ministry of Science and Technology (MOST). The only exception to the requirement of obtaining approval is for clinical trials conducted through international cooperation at clinical trial institutions for the purpose of obtaining the license for the listing of drugs and medical devices in China that does not involve any export of China HGR materials. Such clinical trial collaboration must still be pre-registered with MOST.
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