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Harmonised

Q13 – Training on Continuous Manufacturing of Drug Substances and Drug Products

In Process

Q13 – Training on Continuous Manufacturing of Drug Substances and Drug Products

Pre-harmonisation

Q13 – Training on Continuous Manufacturing of Drug Substances and Drug Products

Harmonised

Q2(R2)/Q14 – Training on Validation of Analytical Procedures and Analytical Procedure Development

In Process

Q2(R2)/Q14 – Training on Validation of Analytical Procedures and Analytical Procedure Development

Pre-harmonisation

Q2(R2)/Q14 – Training on Validation of Analytical Procedures and Analytical Procedure Development

Harmonised

S1B(R1) – Training on Testing for Carcinogenicity of Pharmaceuticals

In Process

S1B(R1) – Training on Testing for Carcinogenicity of Pharmaceuticals

Pre-harmonisation

S1B(R1) – Training on Testing for Carcinogenicity of Pharmaceuticals

Harmonised

S5(R4) – Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals

In Process

S5(R4) – Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals

Pre-harmonisation

S5(R4) – Revision of S5 Guideline on Detection of Toxicity to Reproduction for Human Pharmaceuticals

Harmonised

S13 – Nonclinical Safety Studies for Oligonucleotide-based Therapeutics

In Process

S13 – Nonclinical Safety Studies for Oligonucleotide-based Therapeutics

Pre-harmonisation

S13 – Nonclinical Safety Studies for Oligonucleotide-based Therapeutics

Harmonised

E2B(R3) – Electronic Transmission of Individual Case Safety Reports (ICSRs)

In Process

E2B(R3) – Electronic Transmission of Individual Case Safety Reports (ICSRs)

Pre-harmonisation

E2B(R3) – Electronic Transmission of Individual Case Safety Reports (ICSRs)

Harmonised

E20 – Adaptive Designs for Clinical Trials

In Process

E20 – Adaptive Designs for Clinical Trials

Pre-harmonisation

E20 – Adaptive Designs for Clinical Trials

Harmonised

E21 – Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

In Process

E21 – Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials

Pre-harmonisation

E21 – Inclusion of Pregnant and Breastfeeding Individuals in Clinical Trials