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Harmonised

M10 – Bioanalytical Method Validation and Study Sample Analysis

In Process

M10 – Bioanalytical Method Validation and Study Sample Analysis

Pre-harmonisation

M10 – Bioanalytical Method Validation and Study Sample Analysis

Harmonised

M11 – Clinical electronic Structured Harmonised Protocol (CeSHarP)

In Process

M11 – Clinical electronic Structured Harmonised Protocol (CeSHarP)

Pre-harmonisation

M11 – Clinical electronic Structured Harmonised Protocol (CeSHarP)

Harmonised

M12 – Drug Interaction Studies

In Process

M12 – Drug Interaction Studies

Pre-harmonisation

M12 – Drug Interaction Studies

Harmonised

M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms

In Process

M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Pre-harmonisation

M13A – Bioequivalence for Immediate-Release Solid Oral Dosage Forms

Harmonised

M13B – Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

In Process

M13B – Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

Pre-harmonisation

M13B – Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver

Harmonised

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

In Process

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

Pre-harmonisation

M14 – General Principles on Plan, Design, Analysis, and Reporting of Non-Interventional Studies That Utilize Real-World Data for Safety Assessment of Medicines

Harmonised

M15 – General Principles for Model-Informed Drug Development

In Process

M15 – General Principles for Model-Informed Drug Development

Pre-harmonisation

M15 – General Principles for Model-Informed Drug Development

Harmonised

M4 – Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

In Process

M4 – Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use

Pre-harmonisation

M4 – Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use