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Australia’s Therapeutic Goods Administration (TGA) is holding a consultation on its plans to publish good manufacturing practice (GMP) certificates and inspection outcomes.

The Pharmaceuticals and Medical Devices Agency (PMDA) published guidance on using a weight of evidence (WOE) approach to assessing the toxicity of monoclonal antibodies in Japan.

The New Zealand government has adopted rules on “consent by verification,” creating a pathway that will fast-track the review of medicines approved by two or more reference regulatory agencies.

Australia’s Therapeutic Goods Administration (TGA) has released guidance on manufacturing, supplying, and advertising compounded medicines to support compliance with its regulatory requirements.

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has begun piloting a fast-track registration pathway for products authorized in the European Union or United States.

Agencies in Malaysia and Thailand have implemented a regulatory reliance program for medical devices after a successful three-month pilot.

CDSCO proposed the system in January 2026 as part of an amendment to the New Drugs and Clinical Trial Rules, 2019. The system is designed to allow companies to start some bioavailability and bioequivalence (BA/BE) studies after notifying authorities of their plans, rather than applying and waiting for permission to initiate the assessments. CDSCO proposed implementing the system 90 days after publication; that date passed last week.

The National Medical Products Administration (NMPA) has published rules strengthening the supervision and administration of contract manufacturers in China.

Indian lawmakers have voted to decriminalize some compliance breaches to reduce regulatory litigation burden, eliminating the potential for prison sentences while increasing monetary fines.