News

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.

Join Cisema and HKSTP for a webinar on Hong Kong’s regulatory pathways and GBA market access for life and health tech ventures.

Proposed reforms to NMPA high-end medical device regulation include faster approvals, streamlined review processes, and closer global standards alignment.

China introduces a dual drug catalog system in 2025, creating new access routes for innovative drugs through commercial insurance.

China’s NMPA revises 2025 regulations for narcotic and psychotropic drug research. Overseas manufacturers must meet strict compliance.

From Sept 2025, Malaysia and Singapore launch a 6-month pilot to fast track medical device registration across ASEAN. Contact Cisema today.