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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.

Many of the bispecific antibodies (BsAbs) approved by global regulators have yet to demonstrate robust clinical benefit beyond surrogate endpoints that led to their initial approval, according to research published in BioDrugs.

Hong Kong’s Department of Health (DH) has begun a phased transition to the independent assessment of primary data on new drugs submitted for approval in the city.

Under EU law, active pharmaceutical ingredients (APIs) shipped from India and other non-listed countries must be supported by a written confirmation certificate stating the product meets good manufacturing practices.

The Philippine Food and Drug Administration (FDA) is holding a consultation into plans to update and standardize the contents of the License to Operate (LTO) for pharmaceutical establishments.

India's Central Drugs Standard Control Organization (CDSCO) has introduced draft legislation describing the requirements for informing authorities of manufacturing changes.

The Indian Council of Medical Research (ICMR) has outlined plans to adopt a single ethics committee review mechanism for clinical trials.