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 proof-of-concept clinical trials designed to report endpoints and data signals to the FDA in real time. Second, the agancy released a Request for Information (RFI) regarding a […]
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 in the UAE’s role from adopting advanced technologies to actively generating pharmaceutical innovation and intellectual property. Precision Oncology Candidate Targets PRMT5 Pathway The candidate, ISM0387, is […]
Federal Institute for Drugs and Medical Devices presents updates on the development of the Iris system in relation to the implementation of ICD-11 (International Classification of Diseases, 11th Revision). Strategy Plan for Iris with ICD-11 To support the development and maintenance of Iris in preparation for ICD-11 implementation, the Iris Core Group established a […]
Introduction European Medicines Agency (EMA) published highlights from the meeting of the Committee for Medicinal Products for Human Use (CHMP) held from 23 to 26 March 2026. The meeting covered recommendations on new medicines, extensions of indications, and outcomes of regulatory procedures. Recommendations for New Medicines The CHMP recommended several medicines for marketing authorisation. […]
Introduction The Spanish Agency for Medicines and Health Products (AEMPS) has published the annual report of the Spanish Pharmacovigilance System for Medicines for Human Use (SEFV-H), highlighting key developments in drug safety pharmacovigilance and adverse drug reaction monitoring during 2025. Pharmacovigilance systems play a critical role in detecting, assessing, and preventing medicine-related risks. The latest […]
The European Medicines Agency will hold a public stakeholder meeting to present the work plan of the 3Rs Working Party (3RsWP) for the 2026–2028 period. The virtual session is scheduled for 31 March 2026 and will focus on initiatives aimed at advancing alternatives to animal testing in the development and evaluation of medicinal products. The […]
On 9 February 2026, the Scientific and Educational Center of the National Center for Expertise of Medicines and Medical Devices announced an online training seminar on pharmacovigilance. The seminar will take place on 11 March 2026 from 10:00 to 13:00 and will be delivered by Malik Abdrakhmanov, PhD, Head of the Department of Pharmacovigilance and […]
ICH public meetings are organised by ICH Members or Observers across their respective regions. These meetings may be held as ICH-branded regional events or in collaboration with non-profit organisations. In addition, ICH stakeholder engagement events—such as webinars, workshops, and meetings—are conducted to gather early input from industry, patients, and regulators on draft ICH Guidelines. Event […]
Artificial intelligence (AI) is rapidly reshaping the way medicines are discovered, developed, evaluated, and monitored. Recognizing both its transformative potential and its inherent risks, international regulators and standards bodies have jointly issued Guiding Principles of Good AI Practice in Drug Development to support the responsible use of AI across the entire drug product life cycle. […]
The UK government has officially launched a pioneering £2 million vaccination pilot program designed to bring life-saving protection directly to families. This initiative empowers NHS health visitors to deliver childhood vaccinations, ensuring that the Benefit Risk profile of early-years immunization is communicated clearly to every household. Breaking Barriers: How the Doorstep Vaccine Scheme Works This […]
Submit RFI/RFP
Request Consultation