ARTICLE

APAC Regulatory Landscape: Current Status and Trends

As of March 2026, the APAC region continues to show a robust regulatory environment with no significant actions reported by major authorities such as PMDA, TGA, CDSCO, NMPA, and HSA. This stability...

REGULATORY · PMDA

Pre-Specifying Manufacturing Changes

PMDA issued guidance on pre-specifying manufacturing change categories under ICH Q12, which will facilitate post-approval revisions. This guidance aims to streamline the process for manufacturers.

REGULATORY · HSA

eCTD Submissions to Launch

HSA will begin accepting live eCTD submissions from April 1, 2026, following a successful six-month test phase. This move is expected to enhance submission efficiency.

REGULATORY · NMPA

Sterilization Validation Policy

NMPA has clarified that only sterilization validation from overseas third-party labs will be accepted, which may impact how companies approach compliance for their products.

NEWS

Regulatory Reliance Pathways

APAC countries are increasingly adopting regulatory reliance pathways, allowing for streamlined access to markets. This trend promotes collaboration among member countries and enhances efficiency.

NEWS

CDSCO Review Timelines

CDSCO's review timelines for product approvals range from 6 to 18 months, depending on the product category, which continues to influence market entry strategies for companies in India.

NEWS

TGA's Abridged Assessments

TGA's guidance allows for abridged assessments leveraging approvals from PMDA, US FDA, or EU regulators, which can significantly reduce time to market for medical devices.