News

China issues further proposals to improve review speed, submission standards, and ethics oversight for innovative drug clinical trials.

The CDE released a draft on ATMPs to refine the regulatory process. Review the guidelines and contact Cisema for assistance.

CDE issues PACMP guidance to streamline post-approval pharmaceutical changes in China. Public comments due by July 8, 2025.

CDE issues geriatric drug development guidelines. Public comments due June 18, 2025. Key impact for international pharma companies.

China's CDE releases draft guidance on selecting subjects for bioequivalence and pharmacokinetic studies of antitumor and biosimilar drugs.

China releases draft guideline on risk management plans for innovative drugs, aligning with global standards. Review impact and prepare compliance steps.

New NMPA methods, including hard particle testing in toothpaste, will be added to China’s cosmetic safety standards effective March 2026.

NMPA’s 2025 IVD Catalogue is now in effect with key changes for overseas registration. Contact Cisema for expert support.

China’s 2025 enforcement cases spotlight compliance risks in medical device online sales and what global sellers must do to stay aligned.

New CDE policies reshape pediatric drug trials in China, focusing on safety and innovation for international pharma compliance.

Learn about CMDE’s new guidelines on titanium implant device registration in China and how they impact international manufacturers.

China's food labelling regulation takes effect March 16, 2027. Learn what international manufacturers must do to ensure compliance.

New CMDE guidelines standardize registration for orthopedic and dental devices in China. Key info for global manufacturers.

Hong Kong 1+ pathway allows submissions based on one CPP along with additional clinical data applicable to the Hong Kong population.

Hong Kong CMPR will be established by 2026, with a phased primary evaluation system for new drug registration implemented through 2030.

China updates mandatory certification rules for electric bicycles. New standards take effect April 2025. GB 17761-2024 mandatory by Sept 1.

China approves sakura polyphenols and black wheat pollen. Understand the impact on international market access and compliance with Cisema.

New CDE policy simplifies TCM registration from HK and Macao into mainland China under NMPA Announcement No. 7 of 2025.

Taiwan restricted cosmetic ingredients list updated: TFDA bans boric acid and tightens dye limits by July 2026.

Explore Cisema’s expert insights from Europe and Asia on AI in healthcare and regulatory pathways approval in China's Greater Bay Area.