| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 5 Jun 2025 | M11 Template: Clinical Electronic Structured Harmonised Protocol (CeSHarP) | Draft | This template is intended for interventional clinical trial protocols and is suitable for all phases and therapeutic areas of clinical research. Interventional trials may include but are not limited to human pharmacology, exploratory, confirmatory and post-approval trials. The template is designed to enable modification suitable for the particular trial. Refer to the sections in the document for additional details and conventions related to flexibility. |
| 5 Jun 2025 | M11 Technical Specification: Clinical Electronic Structured Harmonised Protocol | Draft | The purpose of this document is to serve as a technical representation of the ICH M11 protocol template. This Technical Specification (TS) is aligned with the latest version of the ICH M11 Guideline and protocol template, but with flexibility in addressing data exchange needs per ICH and those of regional authorities. |
| 30 May 2025 | M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver | Draft | This guideline is intended to provide recommendations on obtaining waivers of bioequivalence (BE) studies for one or more additional strengths of a drug product in an application where in vivo BE has been demonstrated for at least one of the strengths. The guideline is applicable during both development and post-approval phases of orally administered immediate release (IR) solid dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and hgranules/powders for oral suspension. |
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medicines-medical devices-regulatory affairs