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The European Parliament and Council have reached a provisional agreement on the Critical Medicines Act (CMA), moving proposals designed to tackle shortages of key medicines closer to law.

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.

MedTech Europe has shared feedback on planned changes to the European Union’s medical device and diagnostic regulations, offering high-level support for the revisions while calling for tweaks to aspects of the proposals.

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

New clinical trial regulations came into force in the UK this week, marking the biggest change in the law on running human studies in the country in more than 20 years.

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 trend for the timing of initial marketing authorization applications (MAAs) to be less predictable is slowly reversing but there remains room for improvement, the European Medicines Agency (EMA) said.

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

European authorities have recommended changes to the regulatory framework to keep pace with the progress of the radiopharmaceutical sector.

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

A European Medicines Agency (EMA) group has recommended actions the regulator and industry can take to accelerate regulatory science research.

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.