News

China's GCP for Drugs (2025) Draft Revision proposes major updates on data governance, sponsor accountability, ethics, and technology use.

China's NIFDC has opened consultation on six draft cosmetic standards covering safety assessment and ingredient management - Comments due: 7 November 2025.

Learn about the 2025 China Energy Label (CEL) update, covering 38 product categories and new implementation rules.

Malaysia’s MDA has increased Class A medical device registration fees effective January 2026 — impacting all new and renewal submissions.

Malaysia MDA's Draft 7th Edition labelling requirements introduce broader e-labelling requirements and stronger accessibility standards.

Latest NMPA drafts propose expanding Unique Device Identification (UDI) rules to nearly all medical devices by 2029.

China’s CDE has launched consultations on six key updates to drug R&D communication in the 2025 draft measures.

Taiwan’s Safety Monitoring & Management Measures improve post-market oversight, advancing the dual-track regenerative medicine framework.

SAMR mandates hazardous substance rules for electrical and electronic products, raising compliance requirements for manufacturers.

Explore China’s latest CDE draft guidelines on oligonucleotide drugs, advanced therapies, & biologics — key insights for regulatory planning.

Get a summary of three new CDE draft regulatory guidelines that cover mRNA vaccine research, DSUR reporting, and CAR-T product instructions.

The Philippines FDA has extended the suspension of the new fees to allow more time for stakeholder consultations and review.

Discover how new China NIFDC guidelines streamline filings for cosmetic raw materials, helping beauty brands enter the market faster.

Explore TFDA’s new AI medical device guidelines in Taiwan and key requirements for registration and compliance.

CDE releases draft guideline introducing flexible regulatory pathways for rare disease drugs to reduce costs and accelerate time-to-market.

China’s NHC has approved 20 new food substances, requiring overseas manufacturers to ensure compliance with the updated regulations.

Discover the latest China life support medical device renewal trends, procurement shifts, and emerging opportunities across national and county markets.

China’s CDE issues draft guidelines on pharmaceutical packaging, impacting GMP compliance and product registration.

China’s new CDE guidelines on Model-Informed Drug Development and rare disease pharmacology: key impacts on regulatory strategy and access.

CDE’s 2024 Annual Report reviews 4,900 clinical trials in China. Contact Cisema for drug registration timelines and regulatory compliance.