Pharma & Biotech

China Releases Revised Draft Procedures for Conditional Drug Approvals: Key Updates and Regulatory Implications

Meta Description Learn how the NIFDC 2025 drug registration testing revision impacts timelines, sample rules, and pre-testing in China’s pharmaceutical market.

China enforces traceability code scanning for medical insurance from July 2025. Overseas drug makers must align systems to maintain market access.

NMPA draft guidance on cell therapy change control, impacting international CGT market access in China.

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

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

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China's CDE releases draft guidance on selecting subjects for bioequivalence and pharmacokinetic studies of antitumor and biosimilar drugs.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's Category C drug list, launching in September 2025, offers a new commercial insurance-based payment path for innovative drugs.