Regulatory News from Across Asia-Pacific

Innovative provisions for cosmetics in Pudong, Shanghai aims to enable customizable product packaging, optimize the route-to-market, etc.

China GB 4943.1-2022 safety requirements aims to improve the product’s level of safety and security from pre-market to post-market.

Cosmetics GMP Good Manufacturing Practices came into force in China on July 1, 2022. Contact Cisema to see if it affects your production.

China Vaccine Production and Distribution Rules were released by the NMPA on July 8, 2022 and came into effect immediately.

China’s NMPA has issued Technical Guidelines for Essential Principles of Safety and Performance of Medical Devices

China drug real-world study design and protocol framework guidelines (draft) for comments will be open until September 7, 2022.

Contract manufacturing of Hong Kong medical device and drug in GBA is supported by China NMPA's implementation plan announced in June 2022

China "urgently needed drugs" temporary import workflow was issued on June 29, 2022, by the NHC and NMPA, covering the requirement details.

China drug registration evaluation report for 2021 released by NMPA CDE shows a record high of 47 innovative drugs passing technical review

China cosmetics sampling inspections are to be strengthened through newly proposed measures for products using a new ingredient.

China medical device clinical evaluation exemption catalogue is released for stakeholder comments. Feedback deadline is August 8, 2022.

China clinical trials for new drug registrations were still dominated by chemical drugs for >70% in 2021 whilst biological products at >26%.

China medical device adverse event monitoring report for 2021 shows 21% increase over the previous year with over 650 000 events reported...

NMPA clinical trial pathway for medical device categories cover ophthalmic, radiation therapy, medical imaging, cardio-vascular surgical, etc.

China’s CDE released guidelines on clinical trials of locally applied, locally acting products to improve drug development and evaluation

Medical device naming rules for China have been added from 16 to 22 guidelines by the NMPA on June 2, 2022.

China’s NMPA has issued draft guidelines on medical device QMS audit for product registration, and open for comments until June 27, 2022.

On July 12, 2022, Cisema will participate in a webinar to share the latest changes in requirements of the China Compulsory Certificate.

The China GMP for Pharmaceutical Packaging guides pharmaceutical marketing license holders in reviewing packaging material suppliers.

China’s NMPA is now accepting comments on the draft of "QMS requirements for 3PL for Medical Devices in China" until June 20, 2022.