Latest Regulatory Updates

This MHRA guidance clarifies which medicines cannot be parallel exported from the UK or hoarded, outlining restrictions to ensure patient access and supply chain security.

The MHRA has issued a Class 4 medicines defect notification regarding Arixtra solution for injection, pre-filled syringes (EL(26)A/04), manufactured by Viatris Products Ltd, due to a quality defect requiring a recall of affected batches.

The FDA is seeking input on standards development for regenerative medicine therapies to ensure quality, safety, and effectiveness as the field evolves.

Project Orbis is an FDA initiative designed to expedite the development and availability of innovative biologic medicines for patients worldwide through international collaborations with regulatory partners.

The FDA approved daratumumab and hyaluronidase-fihj, in combination with bortezomib, lenalidomide, and dexamethasone, for the treatment of newly diagnosed multiple myeloma patients who are not eligible for autologous stem cell transplantation.

This FDA consumer update explains the different types of products the agency approves, including generic drugs and biologics, and outlines the rigorous review process involved in ensuring their safety and effectiveness.

This FDA announcement details patent certifications and suitability petitions received related to abbreviated new drug applications (ANDAs), outlining the agency's review processes under the Orange Book and OMUFA.

The FDA has approved daratumumab, a treatment for multiple myeloma, and Ocumont Eye Ointment to treat bacterial conjunctivitis.

This FDA webpage provides a list of approval notifications for oncology and hematologic malignancy treatments, including updates on drugs like daratumumab.

This announcement details the Generic Drug User Fee Amendments (GDUFA), outlining how user fees support the FDA's review of generic drug applications and related activities.

This document outlines the charter for the Vaccines and Related Biological Products Advisory Committee, detailing its purpose, functions, operating procedures, and member selection process as mandated by the Federal Advisory Committee Act (OMUFA).

This MHRA announcement details field safety notices issued between January 19 and January 23, 2026, concerning various medicinal products and medical devices, requiring action from affected pharmaceutical companies to address identified quality defects.

This FDA warning letter addresses deficiencies observed during an inspection of Center for Immunology Science, LLC's manufacturing facility related to current Good Manufacturing Practice (CGMP) regulations.

This FDA warning letter details deficiencies observed during an inspection of Fulijaya Manufacturing SDN. BHD., citing concerns regarding data integrity and quality control practices.

The MHRA's January 2026 Safety Roundup details updates and actions regarding potential risks associated with Arixtra (enoxaparin), quetiapine, and Ocumont Eye Ointment, including revised prescribing advice and defect notifications.

The MHRA has published timetables outlining the expected submission and assessment periods for innovative medicine applications, aiming to provide clarity and predictability for developers.

This guidance document from the MHRA details the application process and requirements for seeking authorization to conduct clinical trials for medicines in the United Kingdom.

The MHRA has issued a Class 4 medicines defect notification regarding Blumont Pharma Limited's Ocumont Eye Ointment 1% w/w, EL(26)A/03, due to a quality defect affecting the product.

This document details marketing authorisations granted by the MHRA in 2026, outlining key information and dates related to each approval.

The MHRA has announced the granting of parallel import licences for 2026, outlining a framework and assessment timetables for companies seeking to bring medicines into the UK through this route.