Latest Regulatory Updates

The European Medicines Agency (EMA) has released a draft guideline revising the requirements for combined vaccines and associations of immunological veterinary medicinal products, providing updated recommendations for developers.

This reflection paper from the EMA provides guidance on the investigation and assessment of cardiovascular safety risks associated with anticancer medicinal products, outlining expectations for sponsors regarding data collection and evaluation.

The International Council for Harmonisation (ICH) has published the minutes from its 51st Management Committee and Assembly meetings, detailing discussions and decisions related to ongoing harmonization efforts in pharmaceutical technical guidelines.

The MHRA has published guidance following an expert review addressing suspected psychiatric and sexual side effects associated with isotretinoin use, outlining recommendations for prescribers and patients to mitigate these risks.

The FDA has issued an Early Alert regarding a potential quality issue with certain Integra LifeSciences wound and burn dressings, advising users to follow specific instructions for inspection and use.

The FDA has issued an early alert regarding Olympus insufflation units, identifying a potential issue that may impact patient safety and requiring immediate attention from healthcare providers.

This FDA announcement lists new Biologics License Applications (BLAs) approved for orphan products in 2025, providing a public record of these approvals.

This guidance document from the MHRA details the International Recognition Procedure, outlining how foreign regulatory authorities' assessments of medicines can be recognized by the UK for marketing authorization purposes.

This guideline from the EMA details revisions to the European Directorate for Quality of Medicines & HealthCare (EDQM) reference instances, outlining updates to procedures and requirements related to pharmacopoeial standards and quality control.

The MHRA's Innovative Licensing and Access Pathway (ILAP) aims to accelerate the approval of promising new medicines, particularly those addressing unmet needs, by offering tailored support and flexible licensing approaches while ensuring patient safety and benefit.

The FDA's ImportShield program has successfully identified and targeted shipments of violative products, enhancing the agency's oversight at U.S. ports of entry and protecting public health.

The MHRA is piloting a new Route B approach for substantial modifications to marketing authorisations, aiming to expedite assessment and reduce timelines for eligible applications.

This FDA webpage provides a comprehensive list of clinical guidance documents related to the development, licensure, and post-approval activities for biological products.

This FDA webpage lists recently issued guidance documents related to the development, review, and approval of biological products, including those pertaining to Biologics License Applications (BLAs).

The FDA is finalizing changes to food labeling regulations requiring mandatory declaration of gluten-containing ingredients, including those derived from grains like wheat, rye, and barley, to improve clarity for consumers with celiac disease or gluten sensitivities.

This document details the methodology used to calculate key performance indicators (KPIs) for clinical research delivery in the UK, providing transparency on how the MHRA measures and monitors progress.

Carmen Purdel has been elected as the new chair of EMA's Committee for Herbal Medicinal Products, succeeding Manfred Bauer and assuming her role on 1 July 2024.

The FDA webpage outlines the agency's commitment to addressing antimicrobial resistance through various initiatives, including research, stewardship programs, and international collaborations to preserve the effectiveness of antimicrobials.

The EMA has concluded that current advice on the use of paracetamol during pregnancy remains unchanged, emphasizing that it can be used at recommended doses but caution is still advised due to ongoing scientific uncertainty regarding potential risks.

This consultation proposes amendments to existing regulations to streamline the supply and deployment of vaccines in the UK, addressing challenges encountered during the COVID-19 pandemic and aiming for greater preparedness.