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The US Food and Drug Administration (FDA) has announced that starting on 1 October 2026, manufacturers must submit adverse event individual case safety reports (ICSRs) for drugs, biologics, and combination products using the data standards specified in the International Council for Harmonisation’s (ICH) E2B(R3) guideline.

The US Food and Drug Administration (FDA) announced it is unifying its various adverse reporting systems into a single system called the Adverse Event Monitoring System (AEMS). The agency said the move would modernize adverse event reporting systems and provide more transparency.

The European Medicines Agency (EMA) has finalized its guideline on good pharmacovigilance practices about the risks to children exposed to medicines by pregnant and breastfeeding women in utero or via breastmilk.

Industry groups and companies in the medical device sector are urging the US Food and Drug Administration (FDA) to utilize its existing quality management systems (QMS) requirements to oversee the performance of artificial intelligence (AI)-assisted medical devices. They recommend against creating a new oversight framework for this purpose.

Pharmaceutical industry groups are asking the US Food and Drug Administration (FDA) to revise its draft guidance on postapproval methods to capture safety and efficacy data on cell and gene therapies (CGT) to include a broader registry system that can collect postapproval data on these products. This data should be gathered by a variety of public and private organizations, not just clinical professional societies that currently collect postapproval data.

The International Council for Harmonisation (ICH) announced plans to develop two new guidelines on 26 November. One will focus on the use of real-world evidence (RWE) to inform regulatory decision-making, and the other will establish a framework for assessing the utility of comparative efficacy studies in biosimilar development programs. The updates were announced following the ICH Assembly held in Singapore, 18-19 November.

Published as part of PMDA's early consideration series, the document features advice informed by local psoriatic arthritis clinical practice guidelines, recent changes in Japan's drug development landscape, and accumulated scientific knowledge. Japanese psoriatic arthritis guidelines target disease remission, but PMDA said treatment is often guided by 'the more attainable goals of minimal or low disease activity.”

Some of the main reasons the US Food and Drug Administration (FDA) rejects applicants from participating in its Advancing Real-World Evidence (RWE) Program include concerns that proposed real-world data (RWD) studies will use heterogeneous patient populations or that the studies will provide supportive, rather than primary evidence, to support regulatory decisions.