What to Know About Regulations in June 2026

In regulatory news in June 2026, the US FDA accepted the first in silico drug development tool as part of its ISTAND program, approved a variety of drugs that included treatments for rare conditions, and issued guidance on the acceleration of cell and gene therapy.

On June 3, 2026, the agency accepted a letter of intent for an in silico drug development tool (DDT) into its Innovative Science and Technology Approaches for New Drugs (ISTAND) DDT Qualification Program.¹ The DDT is an artificial intelligence-driven digital liver model that predicts drug induced liver injury and will help reduce the use of animals in a nonclinical space and improve predictive toxicology in humans.

In an FDA Voices blog post posted June 8, Dr. Iilun Murphy, director Office of Generic Drugs, Center for Drug Evaluation and Research (CDER), and Dr. Mike Kopcha, director Office of Pharmaceutical Quality, CDER, provided insight into the agency’s approach to generic drug oversight.² Murphy and Kocha acknowledged that the manufacturing of generic drugs is complex and encouraged manufacturers to adopt mature quality management practices beyond what is required by current good manufacturing practices. They also restated the FDA’s support for onshore manufacturing.

The over-the-counter (OTC) intranasal naloxone product, Rextovy, was approved by the FDA on June 16, 2026 for the emergency treatment of opioid overdose.³ The action is part of FDA’s priority to reduce opioid deaths by broadening access to these types of treatments that rapidly reverse the effects of opioid overdose.

"The FDA’s approval of another OTC naloxone nasal spray is an important step in expanding access to a life-saving medication. At the same time, device format and manufacturability remain critical considerations. For customers developing nasal rescue products, early evaluation of filling approach, device compatibility, and supply-chain strategy will be essential," Deborah Smook, VP of Marketing & Business Development for TurboFil Packaging Machines, told PharmTech.

On June 15, the FDA approved teplizumab for a new indication to delay the decline of insulin production in children aged 8 to 17 with stage 3 type 1 diabetes. It’s the first treatment of the indication. Teplizumab was previously approved to delay stage 3 type 1 diabetes in adults and in children with stage 2 type 1 diabetes. The approval was granted through FDA’s accelerated approval pathway.^4,5

FDA Approves Cancer Treatments

Cancer treatment development continues to be a priority for industry and regulators. On June 12, the FDA approved belzutifan, an adjuvant treatment for adults with renal cell carcinoma with a clear cell component.⁶ Also on June 12, the agency approved AstraZeneca’s Truqap in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive prostate cancer that is PTEN-deficient as detected by an FDA-authorized test.⁷

On June 24, 2026, Pfizer and FDA announced the approval of a maintenance treatment for adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) locally advanced or metastatic breast cancer (MBC).⁸

Accelerating Therapy Development and Approval

The FDA has been making moves in supporting innovation in drug development. On June 22, 2026, the agency announced its plans to accelerate and modernize clinical research across the full continuum of drug development. Some of its efforts include a proposed Expedited Investigational New Drug (IND) Pilot Program that collaborates with research institutions to shorten the drug identification and approval time, a Phase 1 IND Navigator webpage, Phase 1 IND CMC wepage, and more.⁹

Rare diseases and unmet needs are another area FDA has been recently focused on. In an FDA Voices blog post, Karim Mikhail, acting director, Center for Biologics Evaluation and Research, Mike Davis, Acting Director, Center for Drug Evaluation and Research, and Amy Comstock Rick, director, Rare Disease Innovation Hub,detailed how the agency is committed to the development of treatments for rare diseases and how its decisions are based on rigorous science and expertise. They also talked about how the perspective of patients is critical to development.¹⁰

What’s New in Europe Regulations?

On June 3, 2026, the European Medicines Agency (EMA) announced that the agency’s Emergency Task Force is discussing clinical trial designs and medical countermeasures to the Ebola outbreak in the Democratic Republic of the Congo and Uganda with the African Medicines Agencyand its national regulatory authorities.¹¹ The organizations are leveraging expertise from the World Health Organization-AFRO African Vaccines Regulatory Forum to address the Ebola outbreak. The collaboration will support “efficient, coordinated and timely regulatory responses to the outbreak.”

There were 104 human medicines recommended by EMA in 2025, according to a report the agency issued on June 11, 2026.¹²The report also detailed the agency’s advances in biosimilar policy, medicines availability, and the integration of artificial intelligence (AI) into agency operations.

On June 12, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) provided highlights from its June meeting, specifically PRAC finished it review of valproate and concluded that the data were inconsistent on the development of neurodevelopmental disorders in children born to men treated with valproate.¹³

Other EMA meeting highlights include notes from EMA’s Management Board meeting, which consisted of a review of the agency’s work on the Ebola outbreak, the 2025 Annual Report, clinical trials in the European Union, preparations for new legislation, and an update from the Network Data Steering Group.¹⁴ And the agency’s Committee for Medicinal Products for Human Use released its meeting summary on June 26, announcing recommendations for 6 new medicines.¹⁵ The committee also announced it has revoked marketing authorization for Tavneos (avacopan), which is used to treat the rare inflammatory conditions, granulomatosis with polyangiitis or microscopic polyangiitis, because its benefits outweigh its risks.¹⁶

In the United Kingdom, the UK Medicines and Healthcare products Regulatory Agency (MHRA) announced a collaboration with the US FDAto establish dedicated, reciprocal liaison officer roles within each organization that will support scientific exchange and tackle regulatory challenges.¹⁷

On June 11, MHRA approved the UK’s first GLP-1 tablet for weight loss and weight management.¹⁸And on June 12, MHRAapproved a new lower dose epinephrine nasal spray for the emergency treatment of anaphylaxis in children 4 years of age and older.¹⁹

And finally, an MHRA report detailed the results of public consultation on the use of AI in healthcare, stating “There is a broad consensus that existing regulatory approaches need to be adapted to meet the rapid pace of change and development of AI technology.”²⁰

“It is an excellent effort from the MHRA in gathering all the input on the use of AI in healthcare from various sectors (patients, researchers, regulators, etc.) that will support the future creation of regulation and standard to ensure the safety and efficacy of the AI in healthcare and that it performs as intended in both pre-market and post-market phases,” independent GMP consultant, Rory Budihandojo, told PharmTech. “This report can be leveraged by other agencies and even better if there’s a concerted effort between inter agencies in creatin a universal regulations that transverse all other regulations (e.g., GMP).”

Updates from Standards Setting Organizations in June 2026

In the world of standard-setting organizations, the US Pharmacopeia (USP) published product-specific biologic standards for public comment on June 1, 2026²¹ and released their annual drug shortages report on June 9.²² According to USP, drug shortages are lasting longer, up from 2 years in 2019 and 4.3 years in 2024 to 5 years in 2025. Product discontinuation is also at a high level, with a 60% increase from 2024 to 2025. However, the total number of shortages decreased by 23% in 2025.

Responding to the USP’s new biologics standards, Joseph Albanese, managing director and consultant with Albanese Consulting, LLC, told PharmTech, that “Stakeholders should be aware that emerging product specific monographs for several biologics that USP has published are not official and not enforceable by the FDA. The emerging standards are based on publicly available scientific information to encourage stakeholder feedback. The monograph can only move to official status when published via the Pharmacopoeial Forum process for stakeholder comments and approved by the expert committee.” 

In Europe, EDQM released its annual report on public health in Europe²³ and published guidelines on supply chain reporting.²⁴

For detailed coverage and expert insights regarding these stories, as well as a list of published guidance documents and upcoming regulatory events, visit PharmTech.com.

References

1. FDA accepts first in silico drug development tool under ISTAND program to help predict drug-induced liver injury. FDA. June 3, 2026. Accessed June 26, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-accepts-first-silico-drug-development-tool-under-istand-program-help-predict-drug-induced-liver
2. Ensuring quality and access: FDA’s approach to generic drug oversight. FDA. June 8, 2026. Accessed June 26, 2026. https://www.fda.gov/news-events/fda-voices/ensuring-quality-and-access-fdas-approach-generic-drug-oversight
3. FDA broadens access to over-the-counter naloxone nasal spray for opioid overdose. FDA. June 16, 2026. Accessed June 26, 2026. https://www.fda.gov/news-events/press-announcements/fda-broadens-access-over-counter-naloxone-nasal-spray-opioid-overdose
4. FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes. Press Release. FDA. June 15, 2026. Accessed June 29, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-tzield-teplizumab-certain-pediatric-patients-recently-diagnosed-stage-3
5. FDA Approves Drug for Pediatric Stage 3 Type I Diabetes. FDA. June 12, 2026. Accessed June 29, 2026. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-pediatric-stage-3-type-i-diabetes
6. FDA approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma. FDA. June 12, 2026. Accessed June 29, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma
7. FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer. Press release. FDA. June 12, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation
8. FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer. Press release. FDA. June 24, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance
9. FDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development. FDA. June 22, 2026. https://www.fda.gov/industry/fda-actions-accelerate-and-modernize-early-and-late-stage-clinical-development
10. Lessons Learned from our Roundtable with Rare Disease Advocates. FDA Voices blog post. FDA. June 18, 2206. https://www.fda.gov/news-events/fda-voices/lessons-learned-our-roundtable-rare-disease-advocates
11. EMA, AMA and African regulatory authorities join forces on Ebola outbreak response. Press release. EMA. June 3, 2026. https://www.ema.europa.eu/en/news/ema-ama-african-regulatory-authorities-join-forces-ebola-outbreak-response
12. EMA’s 2025 annual report shows strong approval numbers for human and veterinary medicines. Press release. EMA. June 11, 2026. https://www.ema.europa.eu/en/news/emas-2025-annual-report-shows-strong-approval-numbers-human-veterinary-medicines
13. Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 8-11 June 2026. Press release. EMA. June 12, 2026. https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-8-11-june-2026
14. EMA Management Board: highlights of June 2026 meeting. Press release. EMA. June 15, 2026. https://www.ema.europa.eu/en/news/ema-management-board-highlights-june-2026-meeting
15. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 June 2026. Press release. EMA. June 26, 2026. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-22-25-june-2026
16. EMA recommends revoking marketing authorisation for Tavneos. Press release. EMA. June 26, 2026. https://www.ema.europa.eu/en/news/ema-recommends-revoking-marketing-authorisation-tavneos
17. Unique liaison programme set to reinforce close collaboration between MHRA and FDA. Press release. MHRA. June 15, 2026. https://www.gov.uk/government/news/unique-liaison-programme-set-to-reinforce-close-collaboration-between-mhra-and-fda
18. First GLP-1 tablet for weight loss approved in the UK. MHRA. Press release. June 11, 2026. https://www.gov.uk/government/news/first-glp-1-tablet-for-weight-loss-approved-in-the-uk
19. Lower dose needle-free allergy treatment approved for younger children. Press release. MHRA. June 12, 2026. https://www.gov.uk/government/news/lower-dose-needle-free-allergy-treatment-approved-for-younger-children
20. MHRA landmark report reveals public views on AI in healthcare. Press release. MHRA. June 11, 2026.https://www.gov.uk/government/news/mhra-landmark-report-reveals-public-views-on-ai-in-healthcare
21. USP Publishes Product-Specific Emerging Biologics Standards for Public Comment. Press Release. USP. June 1, 2026. https://www.usp.org/news/usp-publishes-product-specific-emerging-biologics-standards-for-public-comment
22. USP Annual Drug Shortages Report finds rising discontinuations, hidden upstream risk. Press release. USP. June 9, 2026 https://www.usp.org/news/usp-2026-annual-drug-shortages-report-rising-discontinuations-supply-chain-risk
23. The EDQM highlights its impact on public health in Europe and beyond in its 2025 annual report. Press release. EDQM. June 22, 2026. https://www.edqm.eu/en/-/the-edqm-highlights-its-impact-on-public-health-in-europe-and-beyond-in-its-2025-annual-report
24. EDQM publishes guidelines to increase reporting on disappearances of medicinal products from the legal supply chain. Press release. EDQM. June 18, 2026. https://www.edqm.eu/en/-/edqm-publishes-guidelines-to-increase-reporting-on-disappearances-of-medicinal-products-from-the-legal-supply-chain

Regulatory Guidance Documents Published in June 2026

• Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/drug-and-device-manufacturer-communications-payors-formulary-committees-and-similar-entities
• Certain Postapproval Requirements and Resources for ANDAs https://www.fda.gov/regulatory-information/search-fda-guidance-documents/certain-postapproval-requirements-and-resources-andas
• FDA Issues Draft Guidance to Help Accelerate Cell and Gene Therapies for Patients. https://www.fda.gov/news-events/press-announcements/fda-issues-draft-guidance-help-accelerate-cell-and-gene-therapies-patients
• Forms FDA 3542a and FDA 3542: Questions and Answers
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/forms-fda-3542a-and-fda-3542-questions-and-answers
• Guidance, Master Protocols for Drug and Biological Product Development
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/master-protocols-drug-and-biological-product-development
• Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products, Draft Guidance for Industry
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/demonstrating-substantial-evidence-effectiveness-human-drug-and-biological-products
• Submitting Clinical Trial Datasets to Evaluate the Impact of Immunogenicity on the Pharmacokinetics of a Drug
• https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-clinical-trial-datasets-evaluate-impact-immunogenicity-pharmacokinetics-drug
• Quantitative Systems Pharmacology (QSP)-Based Dose Selection for Minimum Anticipated Biological Effect Level (MABEL) in First-in-Human (FIH) Trials
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/quantitative-systems-pharmacology-qsp-based-dose-selection-minimum-anticipated-biological-effect

June 2026 FDA Warning Letters

• Hubei Gedian Humanwell Pharmaceutical Co., Ltd https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hubei-gedian-humanwell-pharmaceutical-co-ltd-725591-06032026
• Warning letter for Fagron BV
  https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/fagron-bv-724551-05122026

July Regulatory Meetings and Workshops

FDA Meetings

• ClinicalTrials.gov: Essentials for Academic Medical Centers
  https://www.fda.gov/drugs/news-events-human-drugs/clinicaltrialsgov-essentials-academic-medical-centers-07142026
• July 23-24, 2026: Meeting of the Pharmacy Compounding Advisory Committee
  https://www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
• FDA/Health and Environmental Sciences Institute/Safety Pharmacology Society Hybrid Workshop: ICH S7A and New Approach Methodologies (NAMs) in Safety Pharmacology
  https://www.fda.gov/drugs/news-events-human-drugs/fdahealth-and-environmental-sciences-institutesafety-pharmacology-society-hybrid-workshop-ich-s7a
• Accelerating Product Development for Pediatric Systemic Lupus Erythematosus (SLE)
  https://www.fda.gov/drugs/news-events-human-drugs/accelerating-product-development-pediatric-systemic-lupus-erythematosus-sle-07302026

EMA Meetings

• EMA multi-stakeholder workshop on supporting innovation in cardiovascular medicines and medical devices in the EU
  https://www.ema.europa.eu/en/events/ema-multi-stakeholder-workshop-supporting-innovation-cardiovascular-medicines-medical-devices-eu
• Sixteenth industry stakeholder platform on research and development support
  https://www.ema.europa.eu/en/events/sixteenth-industry-stakeholder-platform-research-development-support
• Managing product data quality in PMS: processes, known issues, current status and best practices
  https://www.ema.europa.eu/en/events/managing-product-data-quality-pms-processes-known-issues-current-status-best-practices