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FeaturedThe Power of Proactive Pharmacovigilance
Pharmacovigilance is more than reacting to adverse events—it is about identifying potential safety risks early and taking action before they become bigger challenges. This webinar will explore how…
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ImportantChina Issues Revised Good Clinical Practice Guidelines for Drug Clinical Trials
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,…
ImportantFDA Highlights Ongoing Efforts to Strengthen Generic Drug Quality and Patient Access
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…
ImportantDenmark Updates Guidance on Digital and Decentralised Clinical Trials
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…
ImportantMHRA Explores AI-Driven Approaches to Strengthen Medicines Safety and Development
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…
ImportantMHRA Launches Consultation on Draft Rare Disease Therapies Regulatory Framework
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…
ImportantCzech Republic Highlights Clinical Trial Activities and Regulatory Developments in 2025
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…
ImportantFDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics
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…
ImportantICH M11 Expert Working Group Issues Final Presentation for Clinical Trial Protocol Standardisation
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…
ImportantEMA Launches New Advisory Group on Vaccine Confidence
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…
WarningsChina Releases National Adverse Drug Reaction Monitoring Annual Report 2025
National Medical Products Administration,China NMPA and the National Center for Adverse Drug Reaction Monitoring released the National Adverse Drug Reaction Monitoring Annual Report (2025). The report was published…
Trending topicsFDA Advances Implementation of Real-Time Clinical Trials
FDA Advances Implementation of Real-Time Clinical Trials announced two major steps to support the implementation of real-time clinical trials (RTCTs). First, the agency confirmed the initiation of two…
Trending topicsUAE Advances AI-Driven Drug Development with First Locally Discovered Candidate
Emirates Drug Establishment announced the development of the country’s first fully AI-discovered and developed drug candidate by a research team at Insilico Medicine. This milestone reflects a shift…
ImportantTaiwan FDA Issues Guidelines for Clinical Trial Applications of Human Extracellular Preparations
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…
ImportantMalaysia Launches NPRA GCP, GLP, BE & EC Inspection Dashboard
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…
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