Foreign and domestic food and medical device facilities – including any Hong Kong or mainland Chinese facilities – that do not properly renew their registrations with the FDA can be locked out of the U.S. market. Renewals for both types of facilities are due by the end of this year.
On 21 October, the National Medical Products Administration and the National Administration of Traditional Chinese Medicine jointly issued an announcement supporting research and development (R&D) on alternatives to traditional Chinese medicine (TCM) materials derived from rare and endangered plants and animals. At present, the policy focuses on alternatives for pangolins, antelope horns, bezoars, bear bile powders and caterpillar fungi. R&D outcomes can be registered as scientific and technological TCM achievements and may be recommended for supporting funds. The authorities also intend to strengthen collaborative innovation between the TCM industry and the academic, research and medical sectors.
On 26 September, the National Health Commission, the National Administration of Traditional Chinese Medicine and the National Disease Control and Prevention Administration announced a set of administrative measures to regulate research activities initiated by medical and healthcare institutions in relation to the aetiology, diagnosis and treatment of diseases but not for the purpose of registering products such as drugs and medical devices. The authorities have also outlined mechanisms for the inception and completion of such research projects, their scientific and ethical review, and the disclosure of research information. The measures came into effect on 1 October.