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Harmonised

M4Q – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

In Process

M4Q – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Pre-harmonisation

M4Q – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality

Harmonised

M4S – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety

In Process

M4S – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety

Pre-harmonisation

M4S – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Safety

Harmonised

M4E – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy

In Process

M4E – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy

Pre-harmonisation

M4E – The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Efficacy

Harmonised

Advanced Pharmaceutical Manufacturing

In Process

Advanced Pharmaceutical Manufacturing

Pre-harmonisation

Advanced Pharmaceutical Manufacturing

Harmonised

Advancing Biopharmaceutical Quality Standards

In Process

Advancing Biopharmaceutical Quality Standards

Pre-harmonisation

Advancing Biopharmaceutical Quality Standards

Harmonised

Cell and Gene Therapies Discussion Group (CGTDG)

In Process

Cell and Gene Therapies Discussion Group (CGTDG)

Pre-harmonisation

Cell and Gene Therapies Discussion Group (CGTDG)

Harmonised

Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Discussion Group

In Process

Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Discussion Group

Pre-harmonisation

Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential Discussion Group

Harmonised

GCP Renovation

In Process

GCP Renovation

Pre-harmonisation

GCP Renovation