ARTICLE

NMPA Issues New Guidance for Clinical Trials

The National Medical Products Administration (NMPA) of China has released new trial implementation guidance on January 21, 2026. This guidance standardizes technical requirements for Bayesian external information borrowing methods in drug clinical...

REGULATORY · NMPA

NMPA Releases eCTD V3.2.2 Technical Documents

On January 15, 2026, NMPA released technical documents for eCTD V3.2.2 to standardize electronic submissions of regulatory dossiers, including clinical investigational applications.

REGULATORY · TGA

TGA Implements ICH E6(R3) Good Clinical Practice

As of January 13, 2026, the Therapeutic Goods Administration (TGA) in Australia has formally commenced the implementation of ICH E6(R3) Good Clinical Practice, with a 12-month transition period.

REGULATORY · PMDA

PMDA Guidance on Manufacturing Change Categories

The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has posted guidance on pre-designating manufacturing change categories, applying ICH Q12 requirements.

NEWS

HSA Accepts eCTD Format for Regulatory Filings

The Health Sciences Authority (HSA) of Singapore began accepting actual regulatory dossier filings in eCTD format starting April 1, 2026, following a successful trial period.

NEWS

CDSCO Initiates eCTD Pilot in SUGAM Portal

The Central Drugs Standard Control Organization (CDSCO) in India initiated an eCTD pilot in the SUGAM Portal in 2025, aligning efforts with eCTD 4.0 standards.

NEWS

MFDS Plans Enhanced Quality Control Measures

The Ministry of Food and Drug Safety (MFDS) in South Korea announced plans to establish detailed management measures and enhance quality control through risk information disclosure in 2026.