Pharma & Biotech

China proposes ICH E6(R3) Annex 2 implementation from January 2027, with public comments open for one month from August 10 2026.

The guideline introduces more detailed evidence requirements for Hong Kong and Macao drug imports while retaining a streamlined pathway for products already approved under the GBA Connect scheme.

The draft clarifies when CDE may issue written supplementary information requests and when major deficiencies identified during review may instead lead to a non-approval conclusion.

The R&D import whitelist scheme streamlines customs clearance while maintaining specific eligibility, traceability, and risk-control requirements.

The new edition covers license applications, processing times, renewals, and licensing changes for registered products in Malaysia.

Taiwan TFDA requires license holders of semaglutide and tirzepatide-containing drugsto submit risk assessment and control plans within three months.

Learn the proposed changes to China’s drug traceability system requirements and the key considerations for industry stakeholders.

Explore the latest data on China’s clinical research landscape, including record trial activity, shorter development timelines, and emerging R&D trends.

The 12th national VBP round introduces tighter quality, manufacturing, and IP requirements that pharmaceutical companies must meet to compete.

New NMPA CDE guidelines define CTMP and GTMP boundaries, affecting development strategy, CMC planning, and regulatory engagement in China.

China's updated National Essential Medicines List expands access to innovative medicines, creating new opportunities and strategic considerations for pharmaceutical companies.

China's NMPA expands priority review eligibility for chemical API marketing authorization applications, supporting domestic API production and drug supply.