EMA Highlights | FDA Highlights | Row Highlights
Editor’s Note: Welcome to the first issue of Regulatory News – a monthly digest with regulatory news and updates that I believe are relevant for RA professionals. �� Link to Pdf for downloading
In each issue, you’ll find a brief, structured summary of highlights published during the previous month. This issue focuses on regulatory and guidance news from June 2025. It covers essential developments in trial inclusivity, Real World Evidence, and innovations in review processes, like artificial intelligence and harmonized protocols.
I hope that the Regulatory News will help you stay oriented, inspired, and prepared in an ever-changing regulatory environment.
About Me
Pascale Jean – Regulatory Affairs and Pharmacovigilance expert
I have 20+ years of experience in the pharmaceutical industry, with 12 of those in RA and 9 years in Pharmacovigilance. I combine a solid understanding of drug development with strong skills in submission leadership and cross-functional submission teams. I help projects move forward with clarity, care, and structure.
�� Connect on LinkedIn ��contact@pascalejean.com
Opportunities: If you have a project or assignment where my skills could help, feel free to reach out. I’d be happy to explore it with you.
EMA Highlights
In June, the EMA moved towards more inclusive clinical trials, encouraged advanced therapies, and explored how real-world data can strengthen decision-making. These changes might affect how you design studies or plan your next submission.
Inclusion of pregnant and breastfeeding individuals in clinical trials
EMA published a new guideline supporting safe and ethical inclusion of pregnant and breastfeeding individuals in clinical trials. Historically, these groups have been systematically excluded, leaving critical data gaps. The new guidelines outlines requirements for risk–benefit evaluation, informed consent, safety monitoring, and appropriate study design.
Key takeaway: Review your current clinical trial protocols and informed consent language. Consider how risk management plans and pharmacovigilance systems may need to change to include these populations. �� Link
Conditional approvals & ATMP strategies
Key recommendations from the CHMP’s June meeting:
• Rezdiffra (resmetirom) for non-cirrhotic MASH under conditional approval, supported by interim data and FDA alignment.
• Zemcelpro (dorocubicel) as an advanced therapy medicinal product (ATMP) under PRIME, with rolling review and CAT involvement.
Key takeaway: Early and continuous dialogue with regulatory authorities is vital for advanced therapies and conditional approvals. Plan your submission packages with clear post-approval commitments, quality data, and realistic timelines for confirmatory studies. �� Link
Reflection paper: Real-World Data in non-interventional studies
EMA has published a reflection paper on how the use of real-world data (RWD) from non-interventional studies can be used to generate real-world evidence (RWE). The paper discusses quality standards, transparency, and suitable methods for using RWE in regulatory decision-making.
Key takeaway: This paper is worth reading if you are planning post-authorization safety studies, label extensions, or supportive evidence for new indications. It signals that EMA is open to using RWE in regulatory decision-making. ��Link
PRAC signals: Semaglutide and varicella vaccines under review
PRAC has classified non-arteritic anterior ischaemic optic neuropathy (NAION) as a very rare side effect of semaglutide-containing products (Ozempic, Rybelsus, Wegovy). Treatment should be discontinued if NAION occurs.
At the same meeting, PRAC initiated an Article 31 referral to review encephalitis risks after varicella vaccination (Varilrix, Varivax).
Key takeaway: Check if your safety communication materials (DHPCs), labelling, or risk management plans will need updates. Also consider how your product tracking and pharmacovigilance systems should respond to emerging signals.�� Link
Worth noting:EMA Annual Report 2024
EMA has published its 2024 Annual Report, summarizing a record 114 recommended approvals, 46 of which involved new active substances. The Agency highlights digital innovation through ACT-EU, DARWIN EU, and early steps in using AI in regulatory processes. EMA also outlines preparations for the EU pharmaceutical legislation reform.
Key takeaway: Stay up to date on future requirements for submissions and data management. �� Link
FDA Highlights
In the US, there’s a clear push for faster and smarter regulatory processes, with new AI tools and harmonized protocols leading the way. There are also updates for CMC and antibacterial strategies that could be worth keeping on your radar.
Elsa – FDAs AI tool launched
FDA has introduced Elsa, an AI tool to improve efficiency and performance across its regulatory processes. Elsa is expected to help with risk-based assessments, data pattern recognition, and submission management.
Key takeaway: Stay alert for possible shifts in data expectations, timelines, and submission style as the FDA refines its processes with AI support. �� Link
M11 Technical Specification: Clinical Electronic Structured Harmonized Protocol
The ICH has published the final M11 technical specification, creating a global standard for harmonized electronic clinical trial protocols. Implementation is planned from 2026, aiming to improve consistency and streamline global trials.
Key RA takeaway: Monitor how this new protocol structure will influence eCTD content, CTA/IND submissions, and future site documentation requirements.�� Link
REMS requirements removed for autologous CAR T cell therapies
FDA has decided to remove REMS (Risk Evaluation and Mitigation Strategies) requirements for autologous CAR T products, simplifying risk management and patient access.
Key RA takeaway: If you work with advanced therapies or ATMPs, monitor if EMA or other regulators might mirror this shift in risk management plan expectations. ��Link
Draft Guidance: Q1 Stability Testing of Drug Substances and Drug Products
FDA has released a draft revision of Q1, updating recommendations for stability studies that support drug substances and products. It focuses on study design, storage conditions, and shelf-life estimation. Finalization is likely in 2026.
Key takeaway: Review stability data expectations early to adapt to likely changes in shelf-life justifications and risk assessments.�� Link
Final Guidance: Antibacterial Therapies for Patients with an Unmet Medical Need
The FDA has issued a Q&A-based guidance to support the development of antibacterial drugs targeting serious infections with limited treatment options. It clarifies study endpoints, safety monitoring, and design considerations.
Key takeaway: Relevant for anti-infective pipelines and AMR strategies. Align early with FDA if you have antibiotics under development to maximize regulatory success. �� Link
�� Podcast tip:
FDA’s Michelle Tarver (CDRH Director) recently spoke about advances in device regulation, including breakthrough pathways, home-based care, and the agency’s adoption of AI tools to streamline reviews. Worth a listen for anyone working in regulatory strategy, especially around data-driven and patient-centric devices. ��Link
ROW Highlights
Regulators in the UK, Canada, China, and Japan, as well as IC, have published updates and guidance that may influence how you plan future global submissions or multi-regional trials.
UK Highlights
This month, the MHRA has implemented new Post-Market Surveillance rules for medical devices, significantly expanding requirements for proactive safety monitoring and incident reporting through the MORE portal.
Key RA takeaway: Review your PMS plans and incident-reporting workflows, especially if you handle combination products, to align with the new UK rules. �� Link
Health Canada Highlights
Health Canada has launched a public consultation to remove the requirement for comparative clinical efficacy trials for most biosimilars. The agency expects this will accelerate market access while maintaining safety and efficacy standards.
Key RA takeaway: If you manage biosimilar pipelines, watch this closely. It could reduce clinical study needs and speed up submissions. �� Link
China Highlights
NMPA has expanded its eCTD implementation scope under the “Internet + Drug Regulation” framework. The new provisions, part of the 2025 Pharmacopoeia Edition, are designed to streamline submissions and harmonize data formats.
Key RA takeaway: Prepare now to align your global eCTD structure with China’s rules – this will help reduce rework and avoid submission delays in 2026 and beyond. �� Link
Japan Highlights
PMDA has released new guidance for the development of antibacterial agents against antimicrobial-resistant gram-negative infections. The guidance clarifies clinical endpoints, study populations, and data requirements.
Key RA takeaway: If your pipeline includes antibacterial therapies, review this guidance early to adapt your Japanese clinical plans and pre-submission strategy. �� Link
ICH Highlights
The ICH M11 final technical specification has been published, defining a harmonized electronic clinical trial protocol template. Implementation is targeted for 2026, supporting global alignment and better interoperability in clinical development.
Key RA takeaway: Plan for process updates and system changes in collaboration with clinical teams to adopt the new structured protocol. �� Link