Harmonised S9 S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals Read More In Process S9 S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals Read More Pre-harmonisation S9 – Nonclinical Evaluation for Anticancer Pharmaceuticals Read More
Harmonised S10 S10 – Photosafety Evaluation of Pharmaceuticals Read More In Process S10 S10 – Photosafety Evaluation of Pharmaceuticals Read More Pre-harmonisation S10 – Photosafety Evaluation of Pharmaceuticals Read More
Harmonised S11 S11 – Nonclinical Safety Testing in Support of Development of Paediatric Medicines Read More In Process S11 S11 – Nonclinical Safety Testing in Support of Development of Paediatric Medicines Read More Pre-harmonisation S11 – Nonclinical Safety Testing in Support of Development of Paediatric Medicines Read More
Harmonised S12 S12 – Nonclinical Biodistribution Considerations for Gene Therapy Products Read More In Process S12 S12 – Nonclinical Biodistribution Considerations for Gene Therapy Products Read More Pre-harmonisation S12 – Nonclinical Biodistribution Considerations for Gene Therapy Products Read More
Harmonised E1 E1 – The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions Read More In Process E1 E1 – The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions Read More Pre-harmonisation E1 – The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions Read More
Harmonised E2A E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Read More In Process E2A E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Read More Pre-harmonisation E2A – Clinical Safety Data Management: Definitions and Standards for Expedited Reporting Read More
Harmonised E2B(R3) E2B – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) Read More In Process E2B(R3) E2B – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) Read More Pre-harmonisation E2B – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs) Read More
Harmonised E2C(R2) E2C – Periodic Benefit-Risk Evaluation Report Read More In Process E2C(R2) E2C – Periodic Benefit-Risk Evaluation Report Read More Pre-harmonisation E2C – Periodic Benefit-Risk Evaluation Report Read More
