Clinical Trials

Colorado General Assembly Passes HB26-1325 on Ibogaine Research and Natural Medicine Licensing

In May 2026 the Colorado General Assembly passed HB26-1325, expanding the state’s natural medicine framework to cover ibogaine, creating a conditional ibogaine research pilot program, and tightening licensing, benefit-sharing and advertising rules for natural medicine businesses, with an effective date in August 2026 subject to referendum and funding triggers. These changes signal a more formalised, research-driven and compliance-heavy environment for psychedelic and natural medicine services in Colorado, affecting how ibogaine can be supplied and administered, how healing centres structure sales and licences, and how harm reduction and support services can be marketed and documented.

15 May 2026, 13:34leg.colorado.govUnited States

China CDE Publishes 2025 Annual Drug Evaluation Report

China’s Center for Drug Evaluation has published its 2025 Annual Drug Evaluation Report, detailing last year’s growth in drug registration activity, innovative and rare disease approvals, and extensive use of accelerated review pathways. The report signals continued prioritisation of clinically valuable innovation, expanded technical guidance and ICH alignment, and further digitalisation and reform of China’s drug review system in 2026, shaping expectations for sponsors’ development and submission strategies.

15 May 2026, 13:31cde.org.cnChina

China NMPA Issues 105th Batch of Generic Drug Reference Preparations Directory (Notice No. 17 of 2026)

China’s National Medical Products Administration has issued Notice No. 17 of 2026 to publish the 105th batch of its Catalogue of Reference Preparations for Generic Drugs, with an attached directory of reference products used in quality and efficacy consistency evaluations. Generic drug developers should review the updated list to see whether their products are affected and align upcoming bioequivalence and consistency studies and related submissions with the latest NMPA reference preparations.

15 May 2026, 13:27nmpa.gov.cnChina

US FDA Final Guidance on Developing Drugs for Clostridioides Difficile Infection

In May 2026 FDA issued final guidance for industry on developing drugs to treat, reduce recurrence of, and prevent Clostridioides difficile infection, replacing its 2022 draft. This clarifies FDA’s current expectations for CDI drug development programmes, shaping trial design and regulatory strategy for sponsors planning new or modified indications.

15 May 2026, 09:32fda.govUnited States

US FDA Draft Guidance on Development of Non-Opioid Analgesics for Chronic Pain

In September 2025 the US FDA issued draft guidance outlining its expectations for phase 3 development of non-opioid analgesic drugs to treat chronic pain. Although the comment period closed in November 2025, sponsors planning chronic pain programmes should align trial designs with this framework and monitor for the final guidance, as it will shape US market access expectations for non-opioid analgesics.

15 May 2026, 09:11fda.govUnited States

EMA Restricts Mpox Indication for Tecovirimat SIGA

EMA has restricted the indication for Tecovirimat SIGA so that new patients should not start the medicine for mpox after randomised trials showed no efficacy versus placebo. Use is now limited to smallpox, cowpox and vaccinia-related complications, meaning clinicians and health systems must adjust mpox treatment pathways and reconsider reliance on tecovirimat in outbreak planning.

15 May 2026, 09:02ema.europa.euEuropean UnionNorway

Louisiana HR 174 Seeks Assessment of Fenbendazole for Potential Human Cancer Use

Louisiana House Resolution 174 would direct the state surgeon general and Department of Health to assess the feasibility of repurposing fenbendazole for potential human cancer treatment and other conditions, and to plan engagement with federal regulators. If passed, it would not create immediate compliance duties but signals growing political interest in non-traditional cancer therapies, with a formal report on options and risks due by February 2027.

14 May 2026, 18:46legis.la.govUnited States

Swissmedic Encourages Use of New ISO 14155:2026 for Medical Device Clinical Investigations

Swissmedic has announced the availability of ISO 14155:2026, the revised good clinical practice standard for medical device clinical investigations, and explicitly welcomes and encourages its use. This strengthens expectations around safety planning and ongoing surveillance, so sponsors and investigators in Switzerland should plan to align clinical investigation procedures, documentation, and monitoring frameworks with the new edition.

14 May 2026, 18:33swissmedic.chSwitzerland

EMA Finalises Guideline on Development and Manufacture of Synthetic Peptides (Effective 1 June 2026)

The European Medicines Agency has finalised a scientific guideline governing the development and manufacture of synthetic peptide active substances for human and veterinary medicines, which takes effect on 1 June 2026. From that date, EU marketing authorisation and clinical trial dossiers for peptide products are expected to follow tighter, peptide-specific expectations on starting materials, manufacturing controls, impurity management, conjugation and comparability, increasing planning needs for API suppliers and marketing authorisation holders.

14 May 2026, 05:54ema.europa.euEuropean Union

US FDA CDER Seeks Data for Biomarker Incubator on Urinary Kidney Safety Biomarkers

In May 2026, the US FDA’s Center for Drug Evaluation and Research opened a Federal Register request for information to support a Biomarker Incubator pilot on urinary kidney safety biomarkers of drug-induced kidney injury. Drug developers and researchers using these biomarkers should consider submitting deidentified clinical data and comments by 13 July 2026, as early contributions may shape future biomarker validation standards and how FDA uses such endpoints in regulatory decision-making.

13 May 2026, 19:21govinfo.govUnited States

Colorado Senate Advances Amended HB1325 on Ibogaine Research Pilot and Natural Medicine Licensing

In May 2026 the Colorado Senate advanced an amended HB1325 that would establish an ibogaine research pilot programme and tighten rules for natural-medicine licensing, sales and harm-reduction services. If ultimately enacted and funded, this framework would create a dedicated regulatory path for ibogaine treatments, new licensing and benefit-sharing obligations, and stricter controls on how natural-medicine products are supplied and marketed in Colorado.

13 May 2026, 19:04leg.colorado.govUnited States

California AB 2442 — Peptides Working Group Bill Referred to Appropriations Suspense File

California lawmakers are advancing AB 2442, a bill to convene a state public health working group on investigational peptide and novel therapeutic compounds, with the measure now before the Assembly Appropriations Committee and its first hearing set for 14 May 2026. If enacted, this time-limited framework could shape how manufacturers, clinics, and researchers develop, test, and provide investigational peptide-based therapies in California, signalling potential future state expectations for oversight and access.

12 May 2026, 15:26leginfo.legislature.ca.govUnited States

US FDA Finalizes Guidance for Developing Drugs to Treat Pulmonary Tuberculosis

In May 2026 FDA issued final, non-binding guidance for industry on designing clinical development programs for drugs to treat pulmonary tuberculosis, updating a 2022 draft after public comment. This clarifies expectations on trial design, study populations, endpoints, and nonclinical safety, giving TB drug developers a clearer roadmap for evidence packages likely to meet U.S. approval standards.

12 May 2026, 14:58federalregister.govUnited States

US FDA Issues Final Guidance on Postapproval Pregnancy Safety Studies

In May 2026, the US FDA issued final guidance for industry on designing postapproval pregnancy safety studies for approved drug and biological products. This sets clearer expectations for how sponsors plan and conduct pregnancy safety studies after marketing, shaping pharmacovigilance practice and long-term risk management for these therapies.

10 May 2026, 18:51fda.govUnited States

Colorado HB1325 Would Create Ibogaine Research Pilot Program and Rulemaking Powers

Colorado’s HB1325 has cleared second reading in the House and would create an ibogaine research pilot program, expand Colorado’s natural medicine framework to cover semi-synthetic ibogaine, and authorise rules for ibogaine administration and manufacturing. If enacted, ibogaine developers and treatment providers in Colorado should expect new state licensing conditions, manufacturing standards, and benefit-sharing obligations tied to ibogaine sourcing and use over the coming years.

9 May 2026, 14:15leg.colorado.govUnited States

US FDA Issues Technical Specifications For Submitting Continuous Glucose Monitoring Data In Clinical Trials

FDA has issued a May 2026 technical specifications guidance telling sponsors how to structure and submit continuous glucose monitoring data from clinical trials supporting drug and biologic marketing applications. Sponsors using CGM in trials now face clear expectations to align CDISC SDTM/ADaM datasets, missing-data handling, and CGM device metadata with this guidance, likely requiring updates to data-management pipelines, statistical programming, and study protocols before upcoming submissions.

9 May 2026, 13:27fda.govUnited States

US House Introduces Advancing Safe Medications for Moms and Babies Act of 2026 (H.R. 8651)

A bipartisan bill introduced in the US House in May 2026 would require US health agencies, including FDA and NIH, to update regulations, research priorities, and public education to better include pregnant and lactating women in clinical research. If enacted, this could reshape expectations for clinical trial design and post-market evidence on maternal and infant drug safety, with new funding streams and timelines for agency regulatory changes.

7 May 2026, 20:11govinfo.govUnited States

US FDA Requests Information on Impacts of Patient-Focused Drug Development Meetings

In May 2026, the US Food and Drug Administration opened a public docket to gather examples of how past patient-focused drug development meetings have influenced community engagement, research priorities, advocacy strategies, drug development programs and clinical practice, with comments due by 30 June 2026. Feedback from this consultation may shape how FDA and drug developers use and document patient input in future development and regulatory decision-making, influencing expectations for clinical trial design, evidence generation and patient engagement strategies in new medical products.

7 May 2026, 05:43federalregister.govUnited States

China NMPA Issues Work Procedures for Review and Approval of Conditional Drug Marketing Approval Applications (Announcement No. 41 of 2026)

China’s National Medical Products Administration has issued revised work procedures and a policy interpretation governing how conditional drug marketing approval applications are reviewed and approved, effective from publication in April 2026. These procedures clarify the legal basis, process expectations, and a three-month transition window for marketing authorisation holders of already conditionally approved drugs with expired certificates to seek extended research or confirmatory study changes, which may affect development timelines and lifecycle strategies for innovative therapies in China.

6 May 2026, 19:47nmpa.gov.cnChina

China NHC Issues Implementation Package for Biomedical New Technology Clinical Research and Translation Regulation

China’s National Health Commission has issued an implementation announcement and two detailed norms to activate the new Regulation on Clinical Research and Clinical Translational Application of Biomedical New Technologies from May 2026, covering classification, filing and approval of such technologies. Biomedical innovators and hospitals in China now have a defined “new technology” route distinct from drug and device pathways, with risk-based approval rules and mandatory online processes that will drive decisions on R&D strategy, trial design and timing of clinical translation.

6 May 2026, 07:44nhc.gov.cnChina