PharmTech’s Regulatory Roundup for May 2026

Welcome to PharmTech’s Regulatory Roundup for May 2026.

In the United States, the FDA experienced leadership change, made advances in treatments for unmet needs, and issued a variety of guidance documents in May 2026.

On May 6, the agency announced the launch of one-day inspectional assessments.¹ The pilot program focuses on shorter screening assessments that will complement standard inspections. The agency stated these assessments will support a more robust risk model across agency programs.

“Global health authorities are increasingly utilizing structured data to drive inspections, scientific decision-making, or to identify a shortages critical medicines,” says Joseph Albanese, managing director and consultant with Albanese Consulting, LLC. “Pharmaceutical stakeholders should be aware of this evolution, as it will fundamentally change how they interact with these authorities moving forward.”

“The one-day inspection assessment approach appears to be beneficial and help with the resource allocation and allows the FDA to do more inspections,” says Rory Budihandojo, an independent GMP consultant. “For the industry, it also means less resources needed in hosting the inspection (as opposed to a multiday inspection). However, perhaps other inspectional related steps can also be looked at and be made more efficient. For example, the EIR (Establishment Inspection Report) that the inspector has to prepare after an inspection, it typically takes a significant amount of time to write and prepare. Perhaps this EIR step can be made faster by using voice recording (which can be transcribed) or maybe even a video report instead of a manual textual report.” 

“Quality assurance, regulatory compliance, and speed to market remain critical factors of any product launch. Kindeva welcomes the FDA’s decision to implement more targeted assessments designed to strengthen manufacturing standards across the sector,” Melanie Cerullo, Chief Quality Officer & Head of Regulatory Affairs, told PharmTech. Streamlined one-day inspections will support contract manufacturers during periods of high capacity, particularly as demand for fill finish services continues to grow. Ensuring medicines are delivered safely and efficiently to patients around the world is paramount, and we are encouraged to see a continued focus on enhancing quality oversight to ensure the highest standards are consistently maintained.”

FDA also announced the expansion of its use of artificial intelligence with the upgrade to Elsa 4.0, the agency’s internal AI tool used by agency staff.²

“The announcement by FDA about Elsa 4.0 and the HALO platform is one of the most consequential administrative-technology developments in modern regulatory science,” stresses Robert Dream, managing director of HDR Company. “It is not simply an IT upgrade. It represents a structural transformation in how the FDA may conduct scientific review, manage submissions, coordinate internal knowledge, and potentially accelerate therapeutic approvals.”

“FDA’s continued investment in AI capabilities and data-platform consolidation reflects an important shift toward more integrated, data-driven regulatory oversight,” says Henrik Johanning, senior vice president, quality and strategy at EPISTA. “For industry, this is not only a technology story; it is a regulatory readiness story. Companies will need to ensure that their data governance, documentation practices, quality systems, and digital infrastructure are robust enough to support more real-time, risk-based interactions with regulators. As agencies become more digitally enabled, sponsors and manufacturers will need to match that maturity across the product lifecycle.”

How Is FDA Advancing Treatments for Unmet Needs?

Unmet needs was a focus for the agency in May, with FDA asking for input on drug repurposing to help potentially treat diseases and conditions that do not currently have treatments.³ As part of the input, the agency is also asking for innovative approaches for identifying drugs for repurposing.

On May 8, FDA approved Bizengri, Partner Therapeutics’ treatment for an ultra-rare aggressive cancer in the bile ducts, under the agency’s National Priority Voucher program. This is the agency’s seventh approval as part of the pilot program.⁴

The first treatment for chronic hepatitis delta virus (HDV) infection, a serious condition that can lead to liver fibrosis and/or cancer, was approved by FDA on May 22. Gilead Sciences’ Bulevirtide was approved through Breakthrough Therapy Designation and Orphan-Drug Designation.⁵

The FDA also approved a treatment for unresectable or metastatic triple-negative breast cancer on May 22.⁶

Leadership again changed in FDA on May 12, when it was announced that Commissioner Marty Makary was resigning.⁷ The resignation followed rumors that the White House was planning on replacing the commissioner. Kyle Diamantas, the agency's current Chief of Foods and a Trump-aligned attorney, assumed the role of acting commissioner.⁸

FDA Publishes Guidance Documents

On May 8, FDA published a final guidance document on the collection of pregnancy safety data for drugs and biologics. The document provides methodologies that can be used during post-approval to study the safety of drugs used during pregnancy.⁹

Final guidance on developing drugs for pulmonary tuberculosis was published by the agency in May. The guidance assists sponsors in the clinical development of new antibacterial drugs for pulmonary tuberculosis and finalizes the draft guidance that was published in December 2022.¹⁰

FDA provided flexibility in CMC requirements for cell and gene therapy drugs in a final guidance issued in May. This approach is intended to help expedite the development and review of CGT products for serious or life-threatening conditions that do not currently have treatment.¹¹

"This guidance represents a significant step forward for the CGT field, as it formalizes a more flexible and scientifically driven regulatory approach. By allowing greater consideration of product complexity, manufacturing maturity, and clinical stage, the FDA is helping to enable development strategies that are better aligned with the realities of advanced therapies,” says Abigail De La Pena Garcia, director AAV Technology at Samsung Biologics. “The emphasis on phase-appropriate current good manufacturing practices and release acceptance criteria—as well as on leveraging CMC knowledge across similar CGT products—highlights the growing importance of platform technologies and deep manufacturing expertise in successfully advancing these therapies toward commercialization. This is an important move toward accelerating innovation and patient access without compromising product quality or safety.”

Upcoming FDA Workshops in June 2026

Looking ahead to FDA actions in June¹², the agency is hosting a FDA/MHRA/Health Canada symposium on current topics related to good clinical practice, bioequivalence, and good pharmacovigilance practice from June 2-4 in person at the Library and Archives Canada, in Ottawa and virtually. Regulators, investigators, researchers, sponsor companies, and service providers will be discussing ICH E6(R3), trial design, bioequivalence case studies, and pharmacovigilance compliance updates.

FDA’s Office of Therapeutic Products (OTP) in the Center for Biologics Evaluation and Research is conducting a virtual town hall on June 4 in which experts from OTP’s Office of Review Management & Regulatory Review will answer questions about biologic license applications.

Also on June 4, FDA will be holding a public hearing at its White Oak Campus regarding the National Priority Voucher Pilot Program. The hearing is to gain perspectives from the public about program. Those interested in attending can register on the agency’s website.

An annual generic-drug science public workshop is schedule for June 8 to June 9. The workshop is both virtual and in person and will provide an overview of the status of gener-drug initiatives.

FDA’s Oncology Center of Excellence is presenting “Conversations on Cancer” on June 10 that will be focused on the Project Facilitate resource that helps to streamline access to investigational therapies.

The webcast, Advancing Generic Drug Development: Bioequivalence Challenges for Patient-Centric Oral Formulations, will be held on June 11.Webcast participants will talk about the latest advancements and regulatory considerations in patient-centric generic oral products.

And finally, FDA’s annual public meeting, Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments, being held on June 23 both virtually and in person, allows for public comment on performance commitments for the various user fee programs.

What Is New With European Regulations?

In Europe, the European Medicines Agency provided highlights from its safety committee’s May meeting¹³ and provided recommendations for the 2026/2027 seasonal flu vaccine composition.¹⁴ Most importantly, however, the agency announced¹⁵ that a provisional agreement had been reached between the European Parliament and the Council of the European Union on the proposed Critical Medicines Act. Author Cheryl Barton provides a breakdown of what this might mean for the pharma industry going forward in an article on PharmTech.com.¹⁶

On May 20, EMA, along with the EC and HMA, published a report on the progress of the EU’s new clinical trial targets.¹⁷ According to the agency, these targets strengthen the EU’s position as a destination for clinical research and innovative medicines.

These, along with other regulatory actions, show that regulators are prioritizing treatments for rare diseases by streamlining processes and review times.

References

1. FDA Launches One-Day Inspectional Assessments to Strengthen and Expand Oversight. FDA.gov. Press release. May 6, 2026. https://www.fda.gov/news-events/press-announcements/fda-launches-one-day-inspectional-assessments-strengthen-and-expand-oversight
2. FDA Expands AI Capabilities and Completes Data Platform Consolidation. FDA.gov. Press release. May 6, 2026. https://www.fda.gov/news-events/press-announcements/fda-expands-ai-capabilities-and-completes-data-platform-consolidation
3. FDA Advances Drug Repurposing to Address Unmet Medical Needs. Press release. FDA. May 11, 2026. https://www.fda.gov/news-events/press-announcements/fda-advances-drug-repurposing-address-unmet-medical-needs
4. FDA Grants Seventh Approval under the National Priority Voucher Pilot Program. FDA. Press release. May 8, 2026. https://www.fda.gov/news-events/press-announcements/fda-grants-seventh-approval-under-national-priority-voucher-pilot-program
5. FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection. FDA. Press release. May 22, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-chronic-hepatitis-delta-virus-hdv-infection
6. FDA approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer. FDA. Press release. May 22, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer
7. Appezzato S. FDA Commissioner Marty Makary Resigns Following Industry Pressure. PharmTech.com. May 12, 2026. https://www.pharmtech.com/view/fda-commissioner-marty-makary-resigns-amid-agency-turmoil
8. FDA Overview Organization Chart. FDA.gov. May 20, 2026. https://www.fda.gov/about-fda/fda-organization-charts/fda-overview-organization-chart
9. FDA Issues Guidance to Improve Collection of Pregnancy Safety Data for Drugs and Biologics. FDA Press release. May 8, 2026. https://www.fda.gov/news-events/press-announcements/fda-issues-guidance-improve-collection-pregnancy-safety-data-drugs-and-biologics
10. FDA. Pulmonary Tuberculosis: Developing Drugs for Treatment. Final Guidance. May 2026. FDA.gov. May 8, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pulmonary-tuberculosis-developing-drugs-treatment
11. FDA. Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application, Guidance for Industry. May 2026. FDA.gov. May 5, 2026.
12. FDA Meetings, Conferences and Workshops. FDA.gov. Accessed May 29, 2026. https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops
13. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 4-7 May 2026. EMA. Press release. May 8, 2026. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-4-7-may-2026
14. EU recommendations for 2026/2027 seasonal flu vaccine composition. EMA. Press release. https://www.ema.europa.eu/en/news/eu-recommendations-2026-2027-seasonal-flu-vaccine-composition
15. EMA welcomes political agreement on Critical Medicines Act. EMA. Press release. May 12, 2026. https://www.ema.europa.eu/en/news/ema-welcomes-political-agreement-critical-medicines-act
16. Barton C. The Critical Medicines Act’s Impact on Pharmaceutical Manufacturing and Supply Resilience in Europe. PharmTech.com. May 26, 2026. https://www.pharmtech.com/view/the-critical-medicines-act-s-impact-on-pharmaceutical-manufacturing-and-supply-resilience-in-europe
17. EU tracks progress towards 2030 clinical trial targets. EMA. Press release. May 20, 2026. https://www.ema.europa.eu/en/news/eu-tracks-progress-towards-2030-clinical-trial-targets

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