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79 articles
Important China’s National Medical Products Administration (NMPA), together with the National Health Commission, the State Administration of Traditional Chinese Medicine, and the National Bureau of Disease Control and Prevention,…
Important The U.S. Food and Drug Administration (FDA) has outlined its ongoing efforts to ensure the quality, safety, and availability of generic medicines while continuing to support patient access…
Important The Danish Medicines Agency has updated its guidance on digital and decentralised clinical trials (DCTs). The update, announced on 9 June 2026, aligns with the common EU guidance…
Important The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the launch of a first-of-its-kind regulatory sandbox designed to explore how artificial intelligence (AI) can support safer medicines…
Important A public consultation has been launched on a draft Rare Disease Therapies Regulatory Framework, with comments accepted until 30 July 2026. The proposed framework aims to address challenges…
Important On the occasion of International Clinical Trials Day, the State Institute for Drug Control (SÚKL) published an overview of clinical trial activities and developments in the Czech Republic…
Important U.S. Food and Drug Administration issued a final guidance for industry titled Postapproval Pregnancy Safety Studies on May 8, 2026. The guidance provides recommendations on methodologies that can…
Important International Council for Harmonisation announced on May 12, 2026, that the ICH M11 Expert Working Group issued a final overview presentation at Step 4 of the ICH harmonisation…
Important European Medicines Agency announced the establishment of a new advisory group on vaccine confidence to support the Agency’s efforts to address vaccine hesitancy and strengthen public trust in…
Important Taiwan Food and Drug Administration announced the publication of the “Guidelines for Clinical Trial Applications of Human Extracellular Preparations.” The announcement was issued on April 29, 2026, under…
Important National Pharmaceutical Regulatory Agency (NPRA) announced the official launch of the GCP, GLP, BE and EC Inspection Dashboard on its website. Purpose of the Dashboard The dashboard was…
Important National Pharmaceutical Regulatory Agency announced an update to the application form used for the Certificate of Indication and Declaration Certificate for products registered with the Drug Control Authority.…
Important State Medicines Control Agency (SMCA) published a notice regarding medicinal products that may be subject to the “sunset clause.” The agency compiled a list of medicinal products authorised…
Important U.S. Food and Drug Administration (FDA) issued a draft guidance for sponsors seeking approval of human gene therapy products that involve genome editing technologies. Once finalized, the guidance…
Important Drug Control Authority (DCA) approved updated policies concerning products containing animal-derived materials through Circular NPRA.600-1/9/12 (31). This update introduces a risk-based approach for scientific justification and aligns labelling…
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