Executive Intelligence
Life Sciences Reports
Regulatory, funding, leadership, market and commercial updates selected for life-science executives.
Guidance: Good machine learning practice for medical device development
10 guiding principles that can inform the development of good machine learning practice (GMLP).
Read full reportFDA Seeks Public Input to Support Ibogaine Research
The U.S. Food and Drug Administration today announced a request for information (RFI) describing approaches the agency is considering for the design of early-phase clinical trials of ibogaine drug products and seeking public input on those approaches.
Read full reportClass 3 Medicines Recall: Norgine Limited, MOVICOL Plain 13.7g powder for oral solution, EL(26)A/41
Norgine Limited is recalling specific batches of product as a precautionary measure due to some units containing the incorrect amounts of active ingredients.
Read full reportMeeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September – 1 October
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of the PRAC meeting 28 September - 1 October 2026Draft Reference Number: EMA/PRAC/204838/2026…, PRAC statistics:…
Read full reportRenewing marketing authorisations for medicines
How to renew marketing authorisations for products granted through different routes and at different times.
Read full reportApply for a licence to market a medicine in the UK
An overview of the process to get a marketing authorisation (MA), including submitting, fast-tracking an application, naming your medicine and paying fees.
Read full reportElectronic Application Forms (eAF) for UK medicines licensing applications
Current eAF forms are available for applicants to download and use. Existing submission routes, validation requirements and assessment processes remain unchanged.
Read full reportDecision: Advertising investigations: September 2026
Decisions made by MHRA on adverts reported to have breached the legislation on advertising medicines.
Read full reportFDA Approves First Heart Valve Designed to Grow with Children
The U.S. Food and Drug Administration today approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for pediatric patients with congenital pulmonary valve disease.
Read full reportMHRA joins global regulators in call to advance alternatives to animal testing
International statement co-developed by UK medicines regulator
Read full reportAdvice on ‘end-of-year’ submission dates for type I variations in 2026
Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings…
Read full reportEMA Management Board: highlights of September 2026 meeting
Mid-year report 2026 from the Executive DirectorEMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and…
Read full reportClass 4 Medicines Defect Notification: Neuraxpharm UK Limited, Levetiracetam Neuraxpharm granules for oral solution in sachet, EL(26)A/40
Neuraxpharm UK Limited have informed the MHRA that a review of the approved Patient Information Leaflet (PIL) has identified discrepancies between the current Neuraxpharm product safety information and the corresponding reference product information.
Read full reportAccess, new active substance and biosimilar work sharing initiatives
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Read full reportGlobal regulators call for advancing alternatives to animal testing across the medicine lifecycle
EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…
Read full reportExecutive Director speech at EMA women’s health multi-stakeholder workshop
Amsterdam, 28 September 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Good morning,…
Read full reportExecutive Director speech at EMA women’s health multi-stakeholder workshop
Amsterdam, 28 September 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Good morning,…
Read full reportDIA and MHRA announce speaker line-up for inaugural global summit
International leaders will gather to address some of the most significant opportunities and challenges facing healthcare today at the DIA-MHRA Global Summit.
Read full reportGuidance: 14-day assessment stepwise implementation programme for Phase 1 clinical trials
The stepwise implementation programme aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
Read full reportFDA Launches Nationwide Effort to Expand Scientific Expertise and Consumer Voices to Advisory Committees
The U.S. Food and Drug Administration today announced a broad, nationwide recruitment effort to expand the range of qualified voices and perspectives on its advisory committees— the independent bodies that inform some of the most consequential decisions in American public health.
Read full reportWomen are missing from medicines development: EMA’s roadmap for change
By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This…, Women are still missing: from research and data, prevention, diagnosis and treatment. But the…
Read full reportFDA Investigation Leads to Charges Against Two Indian Nationals Involved in Transnational Counterfeit Drug Distribution Scheme
The U.S. Attorney’s Office for the Middle District of Florida and the Criminal Division of the U.S. Department of Justice today announced federal charges against Swapnadip Roy, 33, and Vicky Ramancha, 37, both Indian nationals.
Read full reportGuidance: The Centres of Excellence for Regulatory Science and Innovation programme (CERSIs)
A national programme to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
Read full reportGuidance: The Centres of Excellence for Regulatory Science and Innovation programme (CERSIs)
A national programme to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
Read full report