Quality Guidelines

Q1A-Q1F: Stability

Q2: Analytical Validation

Q3A-Q3E: Impurities

Q4A-Q4B: Pharmacopoeias

Q5A-Q5E: Quality of Biotechnological Products

Q6A-Q6B: Specifications

Q7: Good Manufacturing Practice

Q8: Pharmaceutical Development

Q9: Quality Risk Management

Q10: Pharmaceutical Quality System

Q11: Development and Manufacture of Drug Substances

Q12: Lifecycle Management

Q13: Continuous Manufacturing of Drug Substances and Drug Products

Q14: Analytical Procedure Development.

Safety Guidelines

S1A-S1C: Carcinogenicity Studies

S2: Genotoxicity Studies

S3A-S3B: Toxicokinetics and Pharmacokinetics

S4: Toxicity Testing

S5: Reproductive Toxicology

S6: Biotechnological Products

S7A-S7B: Pharmacology Studies

S8: Immunotoxicology Studies

S9: Nonclinical Evaluation for Anticancer Pharmaceuticals

S10: Photosafety Evaluation

S11: Nonclinical Paediatric Safety

S12: Non-clinical Biodistribution Considerations for Gene Therapy Products.

Efficacy Guidelines

E1: Clinical Safety for Drugs used in Long-Term Treatment

E2A-E2F: Pharmacovigilance

E3: Clinical Study Reports

E4: Dose-Response Studies

E5: Ethnic Factors

E6: Good Clinical Practice

E7: Clinical Trials in Geriatric Population

E8: General Considerations for Clinical Trials

E9: Statistical Principles for Clinical Trials E10 Choice of Control Group in Clinical Trials

E11-E11A: Clinical Trials in Pediatric Population

E12: Clinical Evaluation by Therapeutic Category

E14: Clinical Evaluation of QT

E15: Definitions in Pharmacogenetics /Pharmacogenomics

E16: Qualification of Genomic Biomarkers

E17: Multi-Regional Clinical Trials

E18: Genomic Sampling

E19: Safety Data Collection

E20: Adaptive Clinical Trials

Multidisciplinary Guidelines.

M1: MedDRA Terminology

M2: Electronic Standards

M3: Nonclinical Safety Studies

M4: Common Technical Document

M5: Data Elements and Standards for Drug Dictionaries

M6: Gene Therapy.

M7: Mutagenic impurities.

M8: Electronic Common Technical Document (eCTD)Biowaivers

M9: Biopharmaceutics Classification System-based

M10: Bioanalytical Method Validation and Study Sample Analysis (CeSHarP)

M11: Clinical electronic Structured Harmonized Protocol

M12: Drug Interaction Studies

M13: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

M14: Use of real-world data in pharmaco-epidemiologicalstudies

M15: General Principles for Model-Informed Drug Development