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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Pharmaceutical industry groups are asking the US Food and Drug Administration (FDA) to revise its draft guidance on postapproval methods to capture safety and efficacy data on cell and gene therapies (CGT) to include a broader registry system that can collect postapproval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.

The International Council on Harmonisation (ICH) on Wednesday announced the adoption of its E2D(R1) guideline, which aims to standardize terminology related to adverse events and streamline procedures and timelines for collecting and reporting post-approval safety data.

As a part of the effort, IPC created a short film on PvPI, a pharmacovigilance comic published in multiple vernacular languages to enhance public awareness, and a new online reporting platform designed for easy access through a QR code.

The International Council on Harmonisation (ICH) announced on Friday the adoption of its M14 guideline, which aims to harmonize the planning, design, and reporting of pharmacoepidemiologic studies that use real-world data (RWD) to evaluate the safety of marketed drugs and vaccines. The guideline also provides high-level best practices for conducting these studies.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is holding a consultation on a policy that exempts medical devices made, used, or modified by health institutions from certain requirements.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released six guidelines to clarify expectations and support the new regulatory framework for decentralized manufacturing (DM), which takes effect on 23 July 2025.

The US Food and Drug Administration (FDA) reported that most drug and biological manufacturers satisfied their postmarketing requirements (PMR) and postmarketing commitments (PMC) during fiscal year 2023, according to the agency's latest annual report.

Leveraging artificial intelligence in product reviews and postmarketing surveillance is a top policy priority for the US Food and Drug Administration (FDA), FDA Commissioner Martin Makary said at the Food and Drug Law Institute (FDLI) Annual Conference on Thursday. He also said the agency will roll out a new framework for communicating about vaccines and again confirmed that the agency is not planning a major reorganization of its product centers.

The Therapeutic Goods Administration (TGA) has confirmed its decision not to register Leqembi to treat Alzheimer's disease in Australia. TGA reiterated its refusal after Eisai asked the agency to reconsider its original rejection.