ARTICLE

Regulatory Innovations Transforming APAC Pharma Landscape

The APAC region is witnessing significant regulatory advancements aimed at enhancing pharmaceutical compliance and efficiency. Key authorities such as the PMDA, TGA, CDSCO, NMPA, and HSA are implementing new guidelines and systems...

REGULATORY · HSA

HSA Accepts eCTD Submissions

As of April 1, 2025, HSA has begun accepting actual eCTD regulatory dossier submissions, marking a significant step towards digital transformation in regulatory processes.

REGULATORY · CDSCO

India Launches Digital Drug Tracking Portal

The Drugs Consultative Committee approved a real-time digital portal for tracking drug production, imports, and sales, enhancing transparency in the pharmaceutical supply chain.

REGULATORY · PMDA

New Guidance on Manufacturing Changes

PMDA has issued guidance on pre-specifying manufacturing change categories as per ICH Q12, requiring drugmakers to designate process parameters in marketing applications.

REGULATORY · MFDS

MFDS Establishes Pre-Submission Consultation

MFDS has formalized pre-submission consultations as official regulation, providing clarity for drug developers in South Korea.

NEWS

HSA Requires Quality Defect Declaration

From June 1, 2025, HSA applicants must submit a letter declaring no known quality defects in CMC packages, enhancing product quality assurance.

NEWS

NMPA Translation Requirements

NMPA mandates that all registration documents be translated into Simplified Chinese, along with electrical safety testing by recognized labs, to streamline the registration process.

NEWS

Malaysia's SODA Amendments

Pending parliamentary passage, the SODA amendments will enable NPRA to implement a Patent Linkage and Pharmaceutical Track and Trace System, improving regulatory oversight.