News

NMPA CDE clarifies CMC expectations for preventive mRNA vaccines, focusing on LNP control, impurity management, and lifecycle comparability.

China’s CDE issued trial guidance on CMC lifecycle changes for cell therapies, emphasizing comparability and risk-based quality assessment.

China’s NMPA will apply ICH M14 to non-interventional real-world evidence safety studies initiated on or after its January 2026 announcement.

China’s State Council has revised the Drug Administration Law implementation regulations under Decree No.828, introducing innovation incentives, expanded data protection, and stricter MAH obligations effective May 15, 2026.

Guangdong’s MPA and Health Commission issued the 2025 GBA Connect “urgently needed” catalogue covering 115 Hong Kong–Macao drugs and devices.

The NMPA has introduced faster review decisions, coordinated inspections, and improved temporary import pathways for urgently needed overseas-marketed drugs.

Vietnam’s Ministry of Health moves to standardize and digitize medical device administration, improving transparency and compliance.

Indonesia’s BPS has updated KBLI business classification codes, impacting licensing, OSS data, and compliance for regulated sectors.

Vietnam temporarily suspends implementation of stricter registration and import inspection rules for health supplement foods.

The draft 2026 catalogue defines which Class III medical devices would require clinical trial approval before trial initiation.

Learn about the 104 products China’s NMPA admitted into the Special Review Procedure for Innovative Medical Devices in 2025.

China’s NMPA launches a 2026–2028 action plan to strengthen cosmetic manufacturing quality systems, raising compliance expectations.

China’s CNCA revised organic certification rules, tightening inspections, traceability, and post-certification oversight.

GB 4824-2025 aligns China’s EMC rules with CISPR 11:2024 and expands coverage to ISM equipment, robots, and medical electrical devices.

China issues technical guidance clarifying when post-filing updates to new cosmetic raw materials are permitted.

Taiwan issued regulations under the Regenerative Medicine Preparations Act, covering cell sourcing, recruitment, registration, and data retention.

China has issued the Fourth Batch of its Encouraged Generic Drugs Catalogue, opening new market opportunities for pharmaceutical companies.

China’s NMPA updated the Medical Device Classification Catalogue, revising requirements and classifications for 31 product categories.

Vietnam's Decree No. 26/2026/ND-CP” confirms MoH oversight of chemicals in medical devices, IVDs, and medicines.

Hong Kong’s Department of Health introduces Pre-NDA meetings to streamline new drug registrations under the “1+” mechanism.