Regulatory Roundup—July 2026

This month in pharmaceutical regulations, in the United States, the FDA proposed modernizing the regulatory infrastructure that governs how drugs are made, and expanded patient access to treatments across oncology, cardiometabolic disease, neurology, and rare genetic disorders.

In FDA news, the agency proposed a rule that would let distributed “hub-and-spoke” manufacturing networks register as a single establishment, while also closing a registration gap for foreign API makers to improve supply chain visibility.¹

What Does the Rule Mean for Industry?

According to Henrik Johanning, senior vice president, Quality & Strategy at Epista, “Registering a distributed network as a single establishment is the right move operationally, but it consolidates quality accountability rather than reducing it. 'One establishment' only holds up if the central quality hub genuinely controls every manufacturing unit,” Johanning told PharmTech. “The same quality system, data integrity, and lifecycle discipline across equivalent sites. The administrative simplification is indeed welcome; what it concentrates in the hub is exactly what manufacturers should be planning for.”

Manish Garg, associate director, IT Applications, Serialization, Track & Trace, at Hikma, told PharmTech that, “The proposed hub-and-spoke registration pathway is narrower than it may first appear. It applies to a specifically defined distributed-manufacturing model which is equivalent manufacturing units operating under a single quality unit and unified pharmaceutical quality system and not to conventional multi-site or CMO-based networks. That distinction matters because, if the rule is finalized, the practical challenge for qualifying manufacturers will not simply be administrative. It will be maintaining two levels of identity and visibility across the same operating network: a consolidated establishment identity and precise unit-level operational records.”

“FDA may allow a qualifying distributed manufacturing establishment to register as one establishment, but its individual units would not become operationally invisible. The proposal would still require an identifier and location information for each distributed manufacturing unit, including advance notification of relocation,” Garg continued. “Manufacturers would therefore need to preserve reliable relationships among FDA registration data, unit locations, quality systems, regulatory submissions, and manufacturing records and, where serialized finished products are involved, the location master data used in traceability systems. A single FDA establishment identity should not be interpreted as permission to collapse the physical-location detail upon which batch genealogy, investigations, inspections, and recalls depend.”

“The foreign-establishment provision may have the more immediate supply-chain impact. By aligning the regulations with the PREVENT Pandemics Act, FDA is clarifying that certain foreign establishments, which includes API manufacturers, would be expressly required to register and provide drug-listing information even when their products undergo further processing at another foreign establishment before reaching the United States,” Garg told PharmTech. “Prior regulations did not directly address this fact pattern; the proposal would close that regulatory visibility gap.This is not ingredient-level serialization or DSCSA-style event-level traceability: it does not create serialized API identifiers or require electronic event exchange for upstream materials. It is, however, a meaningful step toward stronger upstream visibility. The broader signal is that regulatory identity, manufacturing-location data, quality records, and supply-chain data can no longer be governed in entirely separate organizational silos.”

And Jason Bock, founder and CEO of CTMC, provides his perspective on the FDA’s proposed rule to streamline registration for single distributed manufacturing establishments, and what the change may mean for personalized medicines, in a two-part interview with PharmTech.

FDA Updates Guidance and Approves Medicines

In other US regulation updates, the FDA revised draft product-specific guidance documents for 17 generic peptide products—including semaglutide and tirzepatide—tightening expectations for immunogenicity testing, impurity thresholds, and structural characterization ahead of a September comment deadline.²The agency also published guidance regarding the development of psychedelic drugs.³See below for more guidance documents published in July.

The agency approved several medications in July for the treatment of lung and breast cancer, Alzheimer’s, and other conditions. FDA also approved Casgevy, the CRISPR-based gene therapy, for children as young as two with sickle cell disease or transfusion-dependent beta thalassemia, marking the youngest approved age group for gene-editing therapy.⁴ See below for more FDA drug approvals.

Together, these actions show FDA balancing streamlined manufacturing oversight with an accelerating pace of therapeutic innovation.

What’s New in European Pharma Regulations?

In Europe, activity by the European Medicines Agency (EMA) centered on regulatory modernization paired with expanding access to innovative therapies, such as new phased-review pathways, first-in-class oral and implantable medicines, and continued vigilance on drug safety and health equity.

EMA and the European Union's Innovation Council agency, EISMEA, deepened their partnership to help SMEs and biopharma innovators engage with regulatory requirements earlier in development, reducing risk and speeding novel therapies toward patients.⁵

In her final annual address to the European Parliament's health committee, EMA's Executive Director highlighted 104 positive medicine recommendations in 2025 and outlined how the EU's incoming pharmaceutical framework will shorten evaluation timelines and strengthen critical medicines supply chains.⁶

EMA's human medicines committee recommended 12 new medicines in July, including 3 cholesterol therapies and a rare-disease treatment under exceptional circumstances, while rejecting 3 applications and updating COVID-19 vaccines for the new XFG variant.⁷

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) saw record regulatory performance and growing international standing, while reinforcing patient safety vigilance and transparency around UK medicines.

According to MHRA's 2025-26 Annual Report 921 medicines were approved in the past year, and the agency created new frameworks for AI and rare disease regulation—cementing the agency's growing global regulatory influence.⁸

MHRA strengthened safety warnings across all botulinum toxin type A products following rare cases of iatrogenic botulism, urging patients and prescribers to recognize symptoms like difficulty swallowing, slurred speech, or breathing problems that can appear up to four weeks after treatment.⁹

Updates from Standards Organizations

In compendia news, EDQM's classification committee published new evidence-based reviews assessing non-prescription status for paracetamol-ibuprofen combinations and naloxone, guiding how EU member states classify these products for supply.¹⁰

EDQM published a revised European Pharmacopoeia general chapter 5.1.6 that modernizes alternative microbiological methods, clarifying supplier and user responsibilities and introducing risk-based validation strategies ahead of an April 2027 implementation date.¹¹

The European Pharmacopoeia, the Japanese Pharmacopoeia, and the United States Pharmacopeia launched their first trilateral prospective harmonization project, co-developing unified quality standards for osimertinib mesilate and its tablets to reduce duplicate testing across regions.¹²

The European Pharmacopoeia Commission adopted 93 new and revised texts at its 185th session, including new monographs for olaparib and adalimumab, an anti-adulteration test for sorbitol and maltitol, and plans for a working party on 3D-printed medicines.¹³

EDQM opened public consultation on two new European Drug Shortages Formulary monographs, for quetiapine capsules and a sulfamethoxazole/trimethoprim suspension, giving manufacturers standardized formulas to help mitigate supply shortages.¹⁴

EDQM released Pharmeuropa 38.3 with 40 draft monographs and general chapters open for public comment through September 30, covering products from ezetimibe to an RSV vaccine, urging manufacturers to weigh in before drafts become binding standards.¹⁵

EDQM and USP's joint Stakeholder Forum reaffirmed their long-running prospective harmonization partnership, with forum insights now available in a free on-demand course to help industry track global pharmacopoeial alignment.¹⁶

These updates underscore EDQM's focus on accelerating international standards harmonization while keeping the door open for industry input before new requirements take effect.

For more on these and other stories, visit PharmTech.com

References

1. FDA Proposes Rule to Modernize Drug Manufacturing Registration. Press release. FDA. July 10, 2026. Accessed July 31, 2026 https://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration
2. FDA Publishes Revised Draft Product-Specific Guidances for Certain Generic Peptide Products. FDA.gov. Accessed July 31, 2026. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-publishes-revised-draft-product-specific-guidances-certain-generic-peptide-products
3. FDA. Psychedelic Drugs: Considerations for Clinical Investigations. Guidance for Industry. FDA. July 2026. Accessed July 31, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations
4. FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease. Press release. FDA. July 1, 2026. Accessed July 31, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-young-children-sickle-cell-disease
5. EMA and EISMEA boost cooperation to accelerate health innovations. Press release. EMA. July 15, 2026. Accessed July 31, 2026. https://www.ema.europa.eu/en/news/ema-eismea-boost-cooperation-accelerate-health-innovations
6. Executive Director Emer Cooke's speech at the European Parliament's Committee on Public Health. Press release. July 14, 2026. Accessed July 31, 2026. https://www.ema.europa.eu/en/news/executive-director-emer-cookes-speech-european-parliaments-committee-public-health
7. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2026. Press release. EMA. July 24, 2026. Accessed July 31, 2026. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-20-23-july-2026
8. MHRA delivers record performance as 2025-26 Annual Report and Accounts confirms growing global influence. Press release. MHRA. July 16, 2026. Accessed July 31, 2026. https://www.gov.uk/government/news/mhra-delivers-record-performance-as-2025-26-annual-report-and-accounts-confirms-growing-global-influence
9. Updated warnings for botulinum toxin products following rare cases of botulism. Press release. MHRA. July 15, 2026. Accessed July 31, 2026. https://www.gov.uk/government/news/updated-warnings-for-botulinum-toxin-products-following-rare-cases-of-botulism
10. CD-P-PH/PHO publishes two new evidence-based classification reviews. Press release. EDQM. July 20, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/cd-p-ph/pho-publishes-two-new-evidence-based-classification-reviews
11. Publication of revised Ph. Eur. general chapter 5.1.6 on alternative microbiological methods. Press release. EDQM. July 15, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/publication-of-revised-ph.-eur.-general-chapter-5.1.6-on-alternative-microbiological-methods
12. Ph. Eur., JP and USP announce the launch of a trilateral prospective harmonisation project on pharmacopoeial standards for osimertinib mesilate and osimertinib tablets. Press release. EDQM. July 13, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/ph.-eur.-jp-and-usp-announce-the-launch-of-a-trilateral-prospective-harmonisation-project-on-pharmacopoeial-standards-for-osimertinib-mesilate-and-osimertinib-tablets
13. Outcome of the 185th session of the European Pharmacopoeia Commission. Press release. EDQM. July 9, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/outcome-of-the-185th-session-of-the-european-pharmacopoeia-commission
14. Second issue of Pharmeuropa EDSForm published: two new draft European Drug Shortages Formulary monographs are now available for public consultation. Press release. EDQM. July 6, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/second-issue-of-pharmeuropa-edsform-published-two-new-draft-european-drug-shortages-formulary-monographs-are-now-available-for-public-consultation
15. Pharmeuropa 38.3 just released. Press release. July 1, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/pharmeuropa-38.3-just-released
16. USP-EDQM Stakeholder Forum reinforces commitment to pharmacopoeial collaboration and global alignment. Press release. EDQM. July 27, 2026. Accessed July 31, 2026. https://www.edqm.eu/en/-/usp-edqm-stakeholder-forum-reinforces-commitment-to-pharmacopoeial-collaboration-and-global-alignment

FDA Drug July Approvals

• FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy
  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy
• FDA Approves First Oral Therapy that Inhibits Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) to Lower Bad Cholesterol in Adults with High Cholesterol
  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-oral-therapy-inhibits-proprotein-convertase-subtilisinkexin-type-9-pcsk9-lower
• FDA approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer
  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally
• FDA grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors
  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive
• FDA Approves First At-home Starting Dose for Alzheimer’s Disease Treatment
  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-home-starting-dose-alzheimers-disease-treatment
• FDA approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications
  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications
• FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer
  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin
• FDA Approves New Treatment to Reduce Proteinuria in Adults with Primary Immunoglobulin A Nephropathy
  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-treatment-reduce-proteinuria-adults-primary-immunoglobulin-nephropathy
• FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease
  https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-young-children-sickle-cell-disease
• FDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
  https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer
• FDA Approves First Nonprescription Fixed-Dose Combination of Acetaminophen and Naproxen Sodium for 12-Hour Pain Relief
  https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-nonprescription-fixed-dose-combination-acetaminophen-and-naproxen-sodium-12-hour

FDA Guidance Documents Issued in July 2026

• Psychedelic Drugs: Considerations for Clinical Investigations
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/psychedelic-drugs-considerations-clinical-investigations
• Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/formal-meetings-between-food-and-drug-administration-and-sponsors-or-requestors-over-counter
• Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/topical-dermatologic-corticosteroids-in-vivo-bioequivalence-0
• Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
  https://www.fda.gov/regulatory-information/search-fda-guidance-documents/submitting-next-generation-sequencing-data-division-antiviral-products

FDA Warning Letters

FDA, Warning Letter to International Medication Systems Limited, July 2, 2026. Accessed July 31, 2026
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/international-medication-systems-limited-727560-07022026

August Meetings and Workshops

FDA
Drug Repurposing: Considerations for Selection Criteria and Prioritization
August 5, 2026
https://www.fda.gov/drugs/news-events-human-drugs/drug-repurposing-considerations-selection-criteria-and-prioritization-08052026

FDA Public Meeting: FDA-Led Patient-Focused Drug Development Meeting for Nonhealing Chronic Wounds
August 25, 2026
https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds

Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials
August 27, 2026
https://www.fda.gov/drugs/news-events-human-drugs/fda-virtual-workshop-digital-health-technologies-and-statistical-considerations-digitally-derived

Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs
August 27, 2026
https://www.fda.gov/drugs/news-events-human-drugs/advancing-generic-drug-development-leveraging-model-integrated-evidence-mie-development-approval

EMA

Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party
August 12, 2026
https://www.ema.europa.eu/en/events/meeting-medicine-shortages-single-point-contact-spoc-working-party-44