September 2026 included several regulatory updates relevant to Phase I–IV drug and biologic clinical trials, covering clinical trial initiation, clinical pharmacology, GCP oversight, safety reporting, clinical development guidance, and clinical trial modernization.
U.S. Food and Drug Administration (FDA)
Expedited Investigational New Drug (IND) Pilot
15 September 2026
FDA announced their initiative for an Expedited Investigational New Drug (IND) Pilot and began accepting applications on September 15, 2026. The pilot is designed to reduce the time to initiation of first-in-human clinical trials through a collaborative approach to IND preparation. The pilot is designed to test the rolling submission model across a range of modalities. Applicants will be asked to describe the status of their proposed nonclinical program, including CMC, and provide a high-level clinical protocol synopsis in their application. Sponsors have until October 30, 2026, to submit applications. FDA will select and notify chosen participants on December 18, 2026.
Draft updates
Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling
2 September 2026
FDA issued draft guidance on studies evaluating the effects of hepatic impairment on the pharmacokinetics and, where appropriate, pharmacodynamics of drugs, including therapeutic biological products. The recommendations may affect clinical pharmacology study design, data analysis, and dosing decisions during clinical development.
European Medicines Agency (EMA)
Final updates
INS-GCP-1 Procedure for Coordinating Good Clinical Practice Inspections Requested by the CHMP
24 September 2026
EMA updated its procedure for coordinating Good Clinical Practice (GCP) inspections requested by the Committee for Medicinal Products for Human Use (CHMP). The updated procedure is relevant to clinical trial inspection coordination and sponsor inspection readiness.
New CTIS Safety Module for the Annual Safety Report
28 September 2026
EMA updated its guidance on the new Safety Module for Annual Safety Reports (ASRs) in the Clinical Trials Information System (CTIS). The module was integrated into the CTIS workspace on 28 September 2026, affecting the submission and management of annual safety reports for authorised clinical trials.
Draft updates
Draft Guideline on the Clinical Requirements for Medicines Intended for the Treatment of Sickle Cell Disease
24 September 2026
EMA opened consultation on a draft guideline covering the clinical development of medicines for sickle cell disease, with a particular focus on confirmatory Phase III trials. The draft addresses clinical trial design and the generation of efficacy and safety evidence.
Draft Guideline on the Clinical Requirements for Medicines Intended for the Treatment of Thalassaemia
24 September 2026
EMA opened consultation on a draft guideline addressing the clinical development of medicines for alpha- and beta-thalassaemia, with particular emphasis on confirmatory Phase III trials. The draft provides recommendations for generating efficacy and safety evidence to support benefit–risk assessment.
Draft Reflection Paper on the Clinical Investigation of Medicinal Products for the Treatment of Systemic Sclerosis
18 September 2026
EMA opened consultation on a draft reflection paper addressing the clinical investigation of medicinal products for systemic sclerosis. The paper provides considerations for clinical development and evidence generation in this disease area.
Draft Guideline on the Investigation of Interactions in the Gastrointestinal Tract
11 September 2026
EMA opened consultation on a draft guideline covering the design, conduct, and interpretation of in vitro and clinical studies evaluating interactions affecting gastrointestinal drug absorption. The recommendations may be relevant to clinical pharmacology and drug interaction studies during development.
Draft Guideline on Clinical Investigation of Medicinal Products for the Treatment of Migraine and Cluster Headache – Revision 2
10 September 2026
EMA opened consultation on a revised guideline covering clinical development of medicines for the treatment of migraine and cluster headache. The draft provides recommendations for clinical investigation in relevant disease populations and treatment settings.
National Medical Products Administration (NMPA – China)
Final updates
Guidelines for Computerized Systems and Electronic Data in Drug Clinical Trials
22 September 2026
CDE issued a final guideline establishing technical expectations for computerized systems and electronic data used in drug clinical trials. The guideline directly affects data governance, data integrity, system controls, and clinical trial oversight across development.
Draft updates
Draft Implementation Recommendations and Chinese Translation of the ICH
E14/S7B Q&A
ICH E14/S7B: QT/QTc
24 September 2026
CDE opened consultation on implementation recommendations and a Chinese translation of the ICH E14/S7B Q&A. The recommendations address the clinical and non-clinical evaluation of QT/QTc prolongation and potential proarrhythmic effects during drug development.
Therapeutic Goods Administration (TGA – Australia)
Final updates
No new TGA final updates directly affecting Phase I–IV drug or biologic clinical trials were identified during September 2026.
Draft updates
No new TGA draft guidance or consultation specifically affecting Phase I–IV drug or biologic clinical trials was identified during September 2026.
Health Canada
Final updates
Interim Policy for the Modernization of the Clinical Trial Framework
14 September 2026
Health Canada introduced an interim policy to support more flexible conduct of clinical trials while the proposed Clinical Trials Regulations remain under development. The policy addresses selected aspects of clinical trial modernization, including innovative trial delivery approaches and streamlined ethics review models.
Updated Clinical Trial Site Information Form and Instructions
14 September 2026
Health Canada updated the Clinical Trial Site Information (CTSI) form and instructions required from sponsors before initiating a protocol or implementing subsequent amendments at a clinical trial site. The update affects site-level submission requirements for applicable clinical trials.
Draft updates
No new Health Canada draft guidance specifically introducing Phase I–IV drug or biologic clinical trial requirements was identified during September 2026.
International Council for Harmonisation (ICH)
Final updates
No new ICH final guideline publication directly affecting Phase I–IV drug or biologic clinical trials was identified during September 2026.
Draft updates
No new ICH draft guideline publication directly affecting Phase I–IV drug or biologic clinical trials was identified during September 2026.
