U.S. Food and Drug Administration (FDA)
Final Updates
M15: General Principles for Model-Informed Drug Development
FDA adopted the ICH M15 guideline as final guidance for industry. The guidance establishes harmonised principles for planning, evaluating, documenting and submitting model-informed drug development (MIDD) evidence, providing a common framework for using modelling and simulation to support regulatory decision-making throughout drug development.
FDA issued final guidance describing recommendations for preparing and submitting clinical trial datasets used to evaluate the impact of immunogenicity on the pharmacokinetics (PK) of therapeutic proteins. The guidance supports standardized data submissions for regulatory review and is relevant to biologic drug development across clinical phases where immunogenicity assessments are performed.
Draft Updates
Master Protocols for Drug and Biological Product Development (Revision 1)
FDA issued a revised draft guidance providing updated recommendations for the design and conduct of master protocols, including basket, umbrella and platform trials. The revision expands recommendations on protocol structure, statistical considerations, control groups, informed consent and operational considerations, supporting the increasing use of innovative trial designs throughout drug and biologic development.
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
FDA issued a revised draft guidance describing the evidentiary standard required to demonstrate substantial evidence of effectiveness for human drugs and biologics. The guidance clarifies circumstances in which a single adequate and well-controlled clinical trial, supported by confirmatory evidence, may be sufficient to support approval, providing greater flexibility in clinical development programmes.
FDA issued draft guidance describing the use of quantitative systems pharmacology (QSP) modelling to support selection of the minimum anticipated biological effect level (MABEL) when determining starting doses for first-in-human clinical trials. The guidance is particularly relevant for early-phase development of biologics and other products with novel mechanisms of action, helping sponsors integrate mechanistic modelling into dose selection strategies.
FDA issued new draft guidance describing how sponsors may leverage existing scientific and clinical knowledge when developing genome-editing gene therapy products. The guidance discusses the use of prior nonclinical, manufacturing and clinical information to support development programmes and may help streamline early-phase development of genome-editing therapies.
European Medicines Agency (EMA)
Final Updates
Accelerating Clinical Trials in the European Union (ACT EU) Workplan 2026–2027
EMA published the ACT EU Workplan 2026–2027, outlining priorities for further implementation of the Clinical Trials Regulation and improving the European clinical trial environment. Key initiatives include increasing patient involvement, improving transparency and use of clinical trial data, supporting timely reporting of trial results, and enabling innovative clinical trial methodologies.
Draft updates
No new EMA draft guidance or consultation documents specific to Phase I–IV drug or biologic clinical trials were identified during June 2026.
National Medical Products Administration (NMPA – China)
Final updates
No new NMPA or CDE final guidance documents directly affecting Phase I–IV drug or biologic clinical trials were identified during June 2026.
Draft updates
No new NMPA or CDE draft guidance or consultation documents specific to Phase I–IV drug or biologic clinical trials were identified during June 2026.
Therapeutic Goods Administration (TGA – Australia)
Final updates
No new TGA final updates directly affecting Phase I–IV drug or biologic clinical trial design or conduct were identified during June 2026.
Draft updates
No new TGA draft consultations specific to Phase I–IV drug or biologic clinical trials were identified during June 2026.
Health Canada
Final updates
No new Health Canada final guidance specific to Phase I–IV drug or biologic clinical trials was identified during June 2026.
Draft updates
No new Health Canada draft guidance or consultation documents specific to Phase I–IV drug or biologic clinical trials were identified during June 2026.
International Council for Harmonisation (ICH)
Final updates
No new ICH Step 2 or Step 4 clinical trial guideline publications were issued during June 2026. The ICH M15 guideline was adopted by FDA as final guidance during June and is therefore reported under FDA.
Draft updates
No new ICH draft clinical trial guideline publications were identified during June 2026.