ARTICLE

APAC Regulatory Landscape Remains Stable

February 2026 saw no significant regulatory actions across major APAC authorities including PMDA, TGA, CDSCO, NMPA, and HSA. This stability reflects ongoing efforts to streamline processes and maintain efficient pathways for drug...

REGULATORY · PMDA

Pre-Submission Consultation Fees Maintained

PMDA continues to charge approximately USD 10,000 for 2-hour pre-submission consultations, with no changes reported in February 2026.

REGULATORY · TGA

Streamlined Pathways for Generics and OTC Drugs

TGA's review timelines for generics and OTC drugs remain unchanged, continuing to support efficient market access.

REGULATORY · CDSCO

Review Periods Hold Steady

CDSCO maintains review periods of 6-18 months for various product categories, consistent with ongoing guidelines.

NEWS

No New Capacity Expansions Reported

Manufacturing hubs in Japan, Australia, India, and Singapore showed no new capacity expansions or hub designations in February 2026.

NEWS

Sterilization Validation Policy Steady

NMPA continues to require sterilization validation from overseas third-party labs, with no policy changes in February 2026.

NEWS

eCTD v1.1 Submissions Accepted

HSA continues to accept eCTD v1.1 submissions via its previously launched portal, with no new phases mandated.