Quality Guidelines
Q1A-Q1F: Stability | Bracketing and Matrixing | Forced Degradation
Q2: Analytical Validation
Q3A-Q3E: Impurities | Residual Solvents
Q4A-Q4B: Pharmacopoeias
Q5A-Q5E: Quality of Biotechnological Products
Q6A-Q6B: Specifications
Q7: Good Manufacturing Practice
Q8: Pharmaceutical Development
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
