Publication date: 19-Oct-2026 Intelligence OverviewThe European Medicines Agency (EMA) has published a draft chapter of the Data Quality Framework (DQF) for EU medicines regulation, focusing on the collection, management and…
Date: 19-Oct-2026Agency: NPRA Malaysia Intelligence Overview Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 21 of 2026 requiring updates to the package inserts and Consumer Medication Information Leaflets…
Date: 19-Oct-2026Agency: NPRA Malaysia Intelligence Overview Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has issued Directive No. 20 of 2026 requiring the package inserts and Consumer Medication Information Leaflets (RiMUP) of…
Date: 21-Oct-2026 Agency: USFDA Intelligence Overview The U.S. Food and Drug Administration (USFDA) has issued the guidance document Regulatory Considerations for Prescription Drug Use-Related Software: Guidance for Industry. Developed collaboratively…
Date: 20-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA), through its Center for Drug Evaluation and Research (CDER), has issued the technical specifications document Submitting Clinical Trial Data…
Date: 19-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has revised its Small Entity Compliance Guide: Safety Reporting Requirements for INDs and BA/BE Studies in October 2026. The…
Date: 14-Oct-2026 The Saudi Food and Drug Authority (SFDA) has released its new Regulatory Guidance for Submissions and Applications (DS-G-144-V01/261014), taking effect on January 1, 2027. This framework replaces two…
Date: 14-Oct-2026 Intelligence Overview The U.S. Food and Drug Administration (USFDA) has announced the Rare Disease Framework Initiative, aimed at developing a more flexible, consistent, and fit-for-purpose regulatory framework for…
Date: 13-Oct-2026 Inrelligence Overview The National Pharmaceutical Regulatory Agency (NPRA), Malaysia, published a safety alert on 13 October 2026 highlighting the potential risk of intestinal obstruction associated with glucagon-like peptide-1…
Date: 13-Oct-2026 INTELLIGENCE OVERVIEW The National Pharmaceutical Regulatory Agency (NPRA), Malaysia, has announced its year-end payment closure schedule for 2026. The temporary closure will affect payments made through the NPRA…