News

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.

NMPA solicits comments on the revised draft of China's medical device classification for sodium hyaluronate products until June 16, 2022.

China cosmetics label requirements have been clarified by the NIFDC for antioxidants, preservatives, stabilizers added as cosmetic ingredients

China NMPA regulations supporting Good Manufacturing Practice (GMP) of drugs in clinical trials will be implemented on July 1, 2022

The 14th Five-Year Plan for Drug Supervision Network Security and Information Construction issued by the NMPA will focus on 16 missions

China cosmetics quality and safety managers must be appointed to meet the CSAR requirements for filing or registration of cosmetics

CSAR China cosmetics infringements are increasing as witnessed recently with the suspension of production of lavender essential oil

Interested in the recommended paths for China medical device clinical evaluation? Contact Cisema regulatory affairs consultancy & CRO