Pharma & Biotech

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

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

China innovative drug approvals require pre-NDA meetings carried out in the application to address the common pharmacology issues

New drug clinical trial applications 2020 annual report indicated a total of 2602 clinical trial applications received by the CDE.

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

Acceptance and examination of chemical APIs trial guidelines have had its first draft issued in April 2020.

Clinical trials GMP management specification first issued its draft in July 2018. The appendix draft was issued on January 18, 2022.

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.