Harmonised E12 E12 – Principles for Clinical Evaluation of New Antihypertensive Drugs Read More In Process E12 E12 – Principles for Clinical Evaluation of New Antihypertensive Drugs Read More Pre-harmonisation E12 – Principles for Clinical Evaluation of New Antihypertensive Drugs Read More
Harmonised E14 E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Read More In Process E14 E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Read More Pre-harmonisation E14 – The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs Read More
Harmonised E15 E15 – Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories Read More In Process E15 E15 – Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories Read More Pre-harmonisation E15 – Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories Read More
Harmonised E16 E16 – Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions Read More In Process E16 E16 – Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions Read More Pre-harmonisation E16 – Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions Read More
Harmonised E17 E17 – General Principles for Planning and Design of Multi-Regional Clinical Trials Read More In Process E17 E17 – General Principles for Planning and Design of Multi-Regional Clinical Trials Read More Pre-harmonisation E17 – General Principles for Planning and Design of Multi-Regional Clinical Trials Read More
Harmonised E18 E18 – Genomic Sampling and Management of Genomic Data Read More In Process E18 E18 – Genomic Sampling and Management of Genomic Data Read More Pre-harmonisation E18 – Genomic Sampling and Management of Genomic Data Read More
Harmonised E19 E19 – A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials Read More In Process E19 E19 – A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials Read More Pre-harmonisation E19 – A Selective Approach to Safety Data Collection in Specific Late-Stage Pre-approval or Post-Approval Clinical Trials Read More
Harmonised M1 M1 – MedDRA: Medical Dictionary for Regulatory Activities Read More In Process M1 M1 – MedDRA: Medical Dictionary for Regulatory Activities Read More Pre-harmonisation M1 – MedDRA: Medical Dictionary for Regulatory Activities Read More
