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Harmonised

M18 – Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs

In Process

M18 – Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs

Pre-harmonisation

M18 – Framework for Determining the Utility of Comparative Efficacy Studies in Biosimilar Development Programs

Harmonised

M4Q(R2) – Revision of M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

In Process

M4Q(R2) – Revision of M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Pre-harmonisation

M4Q(R2) – Revision of M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Harmonised

M8 – Electronic Common Technical Document (eCTD)

In Process

M8 – Electronic Common Technical Document (eCTD)

Pre-harmonisation

M8 – Electronic Common Technical Document (eCTD)

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

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

E6(R3) Annex 2 – Good Clinical Practice (GCP): Additional Considerations for Interventional Clinical Trials

In Process

E6(R3) Annex 2 – Good Clinical Practice (GCP): Additional Considerations for Interventional Clinical Trials

Pre-harmonisation

E6(R3) Annex 2 – Good Clinical Practice (GCP): Additional Considerations for Interventional Clinical Trials

Harmonised

E14/S7B – Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

In Process

E14/S7B – Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

Pre-harmonisation

E14/S7B – Questions & Answers: Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential

Harmonised

S6 – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

In Process

S6 – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals

Pre-harmonisation

S6 – Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals