This edition includes highlights from EMA, FDA, and selected RoW markets. RoW focus rotates by region – this month: South Korea and Switzerland.

This is my take on developments that may influence regulatory strategy or day-to-day RA work.

As always, please consult official sources or dedicated intel teams for comprehensive coverage and tailored insights. I hope this digest helps you stay oriented, inspired, and prepared in an ever-evolving regulatory landscape.

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

CHMP issues positive opinions for 13 medicines, including biosimilars and generics

At it’s June meeting, CHMP recommended 13 new medicines, including innovative products, biosimilars, generics, and several indication extensions, including approvals in oncology, paediatrics, and advanced therapies.

RA takeaway: CHMP approvals this month (incl. biosimilars, generics, oncology and paediatric uses) may shift the competitive landscape. Watch for indication overlaps, as new entrants can affect pricing, access, and HTA. Even generics can reshape payer expectations. Align your timelines, positioning, and post-authorisation plans accordingly. �� CHMP meeting highlights (June 2025 – EMA)

Concept paper outlines revised GMP guidance for ATMPs

EMA published a concept paper to revise GMP requirements specific to ATMPs, aligning with Annex 1 and ICH expectations. The public consultation closed on 8 July 2025. ISSCR has already submitted feedback promoting integration into EudraLex Volume 4.

RA takeaway: ATMP developers – assess whether current GMP systems align with the proposed change. Particularly relevant for cell and gene therapy submissions in 2025–2026. �� Concept paper on revised GMP guidelines

AI use in EU regulatory network: 27 tools mapped

EMA and HMA released their first AI Observatory report, detailing how artificial intelligence tools are currently used in EU regulatory processes. The system now includes 27 active AI tools, with several having undergone qualification or scientific advice.

RA takeaway: Start reviewing your submission and validation processes in light of evolving expectations. EMA is moving toward clearer oversight of AI-supported regulatory work. �� EMA AI Observatory Report

Also noted

Other updates from EMA in July include:

�� PRAC recommendations on vaccines and immunoglobulins

�� New quality guidance for inhalation and nasal drug products

�� 13th NIOG meeting on nitrosamine risk mitigation

�� EMA-hosted webinar on expert involvement in EU medicine assessment

FDA Highlights

First cell-based gene therapy approved: ZEVASKYN

Bio‑Techne’s Simple Western technology supported FDA approval of ZEVASKYN—the first autologous cell-based gene therapy for RDEB—by enabling reproducible potency assays through Collagen VII quantification in a GMP setting.

RA takeaway: High-precision potency assays are critical in cell/gene therapy CMC. This case highlights the regulatory importance of validated analytics platforms supporting advanced therapy submissions. �� Bio-Techne press release

Mustang Bio’s MB‑101 granted Orphan Drug Designation

FDA has granted Orphan Drug Designation to Mustang Bio’s CAR‑T therapy MB‑101 (IL13Rα2-targeted) for recurrent glioma and glioblastoma. This is based on early clinical data demonstrating durable responses in a high-need indication.

RA takeaway: Orphan designation brings market exclusivity, tax incentives, and fee waivers—de-risking regulatory strategy in rare diseases. For CGT developers, it reinforces the importance of early designation timing and strategic alignment with FDA incentives.�� Mustang Bio ODD announcement

Final FDA guidance on biosimilar sponsor meetings (BsUFA III)

FDA has finalized guidance outlining formal meeting procedures for biosimilar sponsors under BsUFA III. It details meeting types, timelines, documentation standards, and expectations for sponsors seeking early engagement.

RA takeaway: Plan your formal FDA meetings early, particularly for biosimilar development programs. Strategic use of BPD Type I–IV meetings can streamline development and improve regulatory alignment. �� Final FDA guidance – BsUFA III meetings

Also noted

Other FDA updates from July include:

�� FDA issues draft guidance on pregnancy and breastfeeding in clinical trials (ICH E21).

�� Reproxalap NDA accepted for dry eye disease after chamber-style efficacy trial.

�� Isofol holds positive pre-IND meeting for arfolitixorin in metastatic colorectal cancer.

�� Project ORBIS continues enabling parallel oncology reviews.

�� FDA expands use of AI tools internally for device assessments (CDRH).

RoW Highlights – South Korea

The following news items are based on updates reported by Pacific Bridge Medical, one of two highly reliable sources of English-language MFDS news. Their regulatory briefings are widely used by global RA professionals who need accurate and strategic context for planning submissions in Korea.

Systemic regulatory reform at MFDS

South Korea’s Ministry of Food and Drug Safety (MFDS) has implemented systemic regulatory reforms, including shorter review timelines, expanded expert reviewer pools, and a revised fee structure.

RA takeaway: For global regulatory teams, this may impact submission timing and budget planning for APAC filings.

�� Summary from Pacific Bridge Medical

�� Official MFDS announcement (English)

MFDS introduces expedited review pathway (GILJABI)

MFDS has introduced GILJABI, an expedited review pathway for innovative drugs, inspired by FDA’s Breakthrough and EMA’s PRIME programs.

RA takeaway: If APAC commercialization is part of your strategy, evaluate whether your product could benefit from GILJABI in parallel with FDA/EMA fast-track pathways. �� Pacific Bridge Medical

Worth noting about South Korea

MFDS does not consistently publish regulatory updates in English. For strategic, English-language insights grounded in local context, I recommend:

�� Pacific Bridge Medical – U.S.-based, with 30+ years of APAC experience and detailed monthly briefs. Trusted by global pharma for MFDS navigation and regulatory forecasting.

�� Emergo by UL – Global consultancy with strong Korea-specific coverage for medical and combination products. Particularly useful for digital health and post-market strategies.

Both firms are known for high-quality summaries based on Korean-language MFDS sources, without losing nuance.

ROW highlights – Swissmedic

Pilot for accelerated Phase 1 trial review

Swissmedic has launched a pilot program to accelerate the review of early-phase clinical trial applications, particularly for products addressing high unmet medical needs or those involving well-characterised compounds.

RA takeaway: If you’re planning a first-in-human or proof-of-concept trial in Switzerland, consider whether your program qualifies for this faster review route. �� Swissmedic pilot for Phase 1 trials

Also Noted in Swissmedic:

Other updates from Swissmedic in recent months include:

Updated RMP and PSUR guidance aligned with ICH E2E, including a new safety information symbol and submission format.

�� Swissmedic RMP/PSUR guidance

�� Swissmedic PSUR/RMP overview page

A pharmacopoeia amendment clarifying GMP requirements for small-scale preparation, including radiopharmaceuticals and hospital-based reconstitution.

�� Swiss pharmacopoeia GMP clarification

�� Prefer a downloadable version? You can access the print-friendly PDF layout of this issue here

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