Pharma & Biotech

Hong Kong new drug application, fulfilling the conditional requirements, will require one overseas marketing approvals instead of two.

Pre-Phase III drug clinical trial meeting guidelines have been released by the NMPA CDE for trial implementation as of March 22, 2023.

China’s Center for Drug Evaluation has released new Guidelines for Information on China Chemical Drug Instructions and Labels.

Oral solid dosage continuous manufacturing technical guidelines have been issued by the China CDE on Mar. 21, 2023, for trial implementation

Chinese Pharmacopoeia 2020 edition was translated into English and officially published by the Chinese CPC on March 14, 2023.

Hong Kong drug and medical device registrations are increasingly in demand. ​​​​​​​Join the Cisema team for a recap of latest policy updates.

Microbial limits for non-sterile chemical drugs, API and excipients were released in a new set of guidelines by China's CDE in Feb 2023

Expedited safety reporting in drug clinical trials is required for applicants to timely inform the CDE about any SUSAR events

China drug standards draft measures help ensure the safety, effectiveness and quality controllability of drugs in China

Drug recalls in China now designate market authorization holders as the key responsible entity, and have a revised regulatory framework.

Electronic submission for China drug registration applications will be available from January 1, 2023, onwards.

Changes during China drug registration shall refer to the working procedures issued by the Center for Drug Evaluation on November 11, 2022.