Global Clinical Trial Regulatory Updates: July 2026
July brought several meaningful regulatory developments that will influence the design, conduct, and oversight of clinical trials across the global development landscape. Regulators continued to advance modernization efforts through updated Good Clinical Practice guidance, expanded support for decentralized and pragmatic trial designs, refined clinical trial eligibility recommendations, and greater emphasis on model-informed drug development and real-world evidence. At the same time, several agencies released disease-specific draft guidance that will shape future protocol design and evidence generation strategies.
Taken together, these updates reinforce a broader trend toward more flexible, patient-focused, and scientifically robust clinical development. Sponsors that proactively incorporate these evolving expectations into trial planning will be better positioned to navigate regulatory review, improve operational efficiency, and generate evidence that meets the needs of both regulators and patients.
FDA, United States
Final
- Cancer Clinical Trial Eligibility Criteria: Laboratory Values
Issued: July 27, 2026
- FDA recommends selecting laboratory-based eligibility criteria that protect participants without unnecessarily excluding patients from oncology trials. The guidance is particularly relevant to Phase II and III protocol development and may broaden enrollment while improving how representative trial populations are of patients seen in clinical practice.
- Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications
Issued: July 27, 2026
- This guidance includes recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. This guidance is intended to assist interested parties, including sponsors, clinical investigators, and institutional review boards (IRBs), who are responsible for the development and/or oversight of clinical trials.
- Cancer Clinical Trial Eligibility Criteria: Performance Status
Issued: July 27, 2026
- This guidance includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status. This guidance is intended to assist interested parties, including sponsors, clinical investigators, and institutional review boards (IRBs), who are responsible for the development and/or oversight of clinical trials.
- Psychedelic Drugs: Considerations for Clinical Investigations
Issued: July 13, 2026
- The final guidance addresses the distinctive design and conduct issues associated with psychedelic drug trials, including participant safety, dose-response assessment, expectancy and functional unblinding, and the contribution of psychological support. It applies across Phase I–III development programs for psychiatric, substance-use, and other medical indications.
- Submitting Next-Generation Sequencing Data to the Division of Antiviral Products
Issued: July 1, 2026
- FDA finalized technical specifications for submitting next-generation sequencing protocols, datasets, and analyses used to characterize antiviral resistance. The update affects Phase I–III antiviral development and may also inform Phase IV resistance surveillance by standardizing the data FDA uses to independently assess emerging resistant variants.
Draft
- Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts
Issued: July 31, 2026
- The draft clarifies FDA expectations for delivery devices and container-closure systems used with proposed biosimilar and interchangeable products. Although primarily product-development guidance, device or presentation differences could affect comparative-use studies, human-factors evidence, and late-stage clinical strategies intended to support biosimilarity or interchangeability.
EMA and European Union
Final
- ICH E6(R3) Guideline for Good Clinical Practice, Annex 2, Step 5
EU document date: July 13, 2026
- EMA published the EU Step 5 version of Annex 2, covering trials with decentralized elements, pragmatic designs, and real-world data. It affects Phase I–IV programs using remote consent, direct-to-participant activities, digital data collection, routine-care professionals, investigational product shipment, or real-world data sources.
- Clinical Trial Information System Sponsor Handbook, Version 6.4
EMA updated its principal operational guidance for sponsors using CTIS. The handbook applies to Phase I–IV interventional medicinal-product trials in the EU/EEA and supports regulatory submissions, substantial modifications, safety reporting, trial-status updates, transparency obligations, and results disclosure under the Clinical Trials Regulation.
Draft
No qualifying EMA or EU draft clinical-trial guidance first issued during July 2026 was identified.
NMPA and CDE, China
Final
No qualifying final NMPA/CDE guidance directly affecting Phase I–IV drug or biologic trials was identified for July 2026.
Draft
- Q&A on the Guideline for Clinical Trials of Drugs for Chronic Hepatitis B Virus Infection
Issued: July 2026- The draft Q&A provides more detailed recommendations for confirmatory trials targeting functional cure or sustained viral suppression. It addresses Phase II and III population selection, stratification, primary endpoints, superiority thresholds, treatment discontinuation, and post-treatment follow-up.
- Technical Guideline for Communication on Using Real-World Evidence to Support Expansion of Approved Drugs to Pediatric Indications
Issued: July 14, 2026- The draft outlines how real-world evidence may support adding pediatric indications to drugs and therapeutic biologics already approved for adults in China. It is most relevant to Phase IV and lifecycle development, covering data fitness, study design, statistical analysis, safety surveillance, quality controls, ethics, and early regulatory engagement.
- Technical Guideline for Clinical Trials of Rotavirus Vaccines
Issued: July 24, 2026- The draft provides indication-specific recommendations for rotavirus vaccine development across Phase I–III. Key areas include efficacy and safety evaluation, intussusception monitoring, changes in circulating strains, and risks associated with live attenuated vaccines, including shedding and transmission.
- Technical Guideline for the Clinical Development of Innovative Drugs for Primary Immune Thrombocytopenia
Issued: July 24, 2026- The draft addresses early clinical exploration, Phase III registration-study design, efficacy endpoints, treatment duration, and special populations in immune thrombocytopenia development programs. Sponsors should consider its recommendations when planning dose exploration, confirmatory trials, and pediatric or other population-specific development.
- Technical Guideline for Clinical Trial Design in the Development of Drugs for Glioma
Issued: July 31, 2026- The draft sets out CDE’s current considerations for exploratory and confirmatory glioma trials, including development for molecularly defined disease subtypes and pediatric populations. It is primarily relevant to Phase II and III protocol strategy, efficacy assessment, patient selection, and regulatory engagement.
- ICH M15: Model-Informed Drug Development, Draft China Implementation Recommendations and Translation
Issued: July 31, 2026- CDE opened consultation on implementing ICH M15 in China. The guideline can affect Phase I dose selection, Phase II dose-response assessment, Phase III evidence planning, and Phase IV lifecycle decisions by establishing a risk-based framework for evaluating, documenting, and submitting model-informed evidence.
TGA, Australia
Final
- Adoption of International Scientific Guidelines in Australia, R01/2025
Published: July 24, 2026- TGA adopted 23 international guidelines, several of which directly affect Phase I–IV development. Trial-relevant additions cover first-in-human risk mitigation, biological investigational product documentation, subgroup analysis in confirmatory trials, real-world evidence, vaccine evaluation, Crohn’s disease development, factor IX products, and genetically modified cell therapies. Deviations from an adopted guideline relevant to a regulatory application are expected to be justified.
Draft
- Consultation on Adoption of International Scientific Guidelines in Australia, R01/2026
- TGA is consulting on 11 additional guidelines, including indication-specific guidance for ulcerative colitis and diabetes, immunogenicity assessment, factor VIII products, ICH E19 selective safety-data collection, ICH M11 structured protocols, influenza vaccines, and a tailored clinical approach to biosimilar development. Adoption would affect protocol structure, Phase II and III designs, late-stage and postapproval safety collection, biologic immunogenicity strategies, and biosimilar evidence requirements.
Health Canada
Final
- Guidance on the Registration of Clinical Trials and Public Disclosure of Results
Effective: July 29, 2026- The guidance applies to Phase I–III drug and biologic trials regulated in Canada. Sponsors are expected to register trials in a WHO-compliant registry before enrollment where possible, and no later than 21 days after the first participant is enrolled, then submit summary results within 12 months of primary study completion. Phase IV trials involving products used within their authorized conditions are outside its stated scope.
Draft
No new Health Canada draft guidance directly affecting Phase I–IV drug or biologic trials was identified for July 2026.
ICH
Final
- ICH E6(R3) Good Clinical Practice Annex 2 Adopted and Published
Publication announcement: July 10, 2026- ICH published the consolidated E6(R3) guideline combining the principles, Annex 1, and the newly adopted Annex 2. Annex 2 adds GCP expectations for decentralized and pragmatic elements, remote data collection, real-world data, investigational-product distribution, privacy, oversight, and safety management across Phase I–IV trials.
Draft
No new ICH draft clinical-trial guideline was issued during July 2026.