Welcome to the 2nd edition of Regulatory News – a monthly digest for RA professionals. Each edition summarises key regulatory developments from the previous month, spanning guidance, reviews, safety signals, and innovation.
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
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