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Harmonised

M3 – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

In Process

M3 – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Pre-harmonisation

M3 – Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals

Harmonised

M5 – Data Elements and Standards for Drug Dictionaries

In Process

M5 – Data Elements and Standards for Drug Dictionaries

Pre-harmonisation

M5 – Data Elements and Standards for Drug Dictionaries

Harmonised

M6 – Virus and Gene Therapy Vector Shedding and Transmission

In Process

M6 – Virus and Gene Therapy Vector Shedding and Transmission

Pre-harmonisation

M6 – Virus and Gene Therapy Vector Shedding and Transmission

Harmonised

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

In Process

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Pre-harmonisation

M7 – Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk

Harmonised

M8 eCTD v3.2.2 – Electronic Common Technical Document (eCTD) v3.2.2

In Process

M8 eCTD v3.2.2 – Electronic Common Technical Document (eCTD) v3.2.2

Pre-harmonisation

M8 eCTD v3.2.2 – Electronic Common Technical Document (eCTD) v3.2.2

Harmonised

M8 eCTD v4.0 – Electronic Common Technical Document (eCTD) v4.0

In Process

M8 eCTD v4.0 – Electronic Common Technical Document (eCTD) v4.0

Pre-harmonisation

M8 eCTD v4.0 – Electronic Common Technical Document (eCTD) v4.0

Harmonised

M8 – Electronic Common Technical Document (eCTD)

In Process

M8 – Electronic Common Technical Document (eCTD)

Pre-harmonisation

M8 – Electronic Common Technical Document (eCTD)

Harmonised

M9 – Biopharmaceutics Classification System-based Biowaivers

In Process

M9 – Biopharmaceutics Classification System-based Biowaivers

Pre-harmonisation

M9 – Biopharmaceutics Classification System-based Biowaivers