Pharma & Biotech

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

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

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

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

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

Measures for the Supervision and Administration of Drug Production was issued by the SAMR and came into effect on July 1, 2020.

Measures for the Administration of Drug Registration took effect on July 1, 2020, to reform the drug review and approval system.

The Guideline for Pharmacovigilance Inspection urge MAHs to implement the main responsibility of pharmacovigilance.

China Drug Annual Reports Administrative Regulations was issued by the National Medical Products Administration on April 12, 2022.