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| Stability | |
|
Q1A(R2)
|
Stability Testing of New Drug Substances and Products |
|
Q1B
|
Stability Testing : Photostability Testing of New Drug Substances and Products |
|
Q1C
|
Stability Testing for New Dosage Forms |
|
Q1D
|
Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Products |
|
Q1E
|
Evaluation of Stability Data |
|
Q1F
|
Stability Data Package for Registration Applications in Climatic Zones III and IV |
| Analytical Validation | |
|
Q2(R1)
|
Validation of Analytical Procedures: Text and Methodology |
| Impurities | |
|
Q3A(R2)
|
Impurities in New Drug Substances |
|
Q3B(R2)
|
Impurities in New Drug Products |
|
Q3C(R4)
|
Impurities: Guideline for Residual Solvents |
|
Procedures
described
|
Impurities:
Guideline for Residual Solvents (Maintenance) PDE for Tetrahydrofuran in Q3C(R3) |
| PDE for N-Methylpyrrolidone in Q3C(R3) | |
| Pharmacopoeias | |
|
Q4
|
Pharmacopoeias |
|
Q4A
|
Pharmacopoeial Harmonisation |
|
Q4B
|
Regulatory Acceptance of Pharmacopoeial Interchangeability |
| Quality of Biotechnological Products | |
|
Q5A(R1)
|
Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin |
|
Q5B
|
Quality of Biotechnological Products : Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products |
|
Q5C
|
Quality of Biotechnological Products : Stability Testing of Biotechnological/Biological Products |
|
Q5D
|
Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products |
|
Q5E
|
Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process |
| Specifications | |
|
Q6A
|
Specifications : Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products : Chemical Substances (including Decision Trees) |
|
Q6B
|
Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products |
| Good Manufacturing Practice | |
|
Q7
|
Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients |
| Pharmaceutical Development | |
|
Q8(R2)
|
Pharmaceutical Development |
| Risk Management | |
|
Q9
|
Quality Risk Management |
| Pharmaceutical Quality System | |
|
Q10
|
Pharmaceutical Quality System |
| Development and Manufacture of Drug Substances | |
|
Q11
|
Development and Manufacture of Drug Substances |
 TOP |
| Carcinogenicity Studies | |
|
S1A
|
Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals |
|
S1B
|
Testing for Carcinogenicity of Pharmaceuticals |
|
S1C(R2)
|
Dose Selection for Carcinogenicity Studies of Pharmaceuticals |
| Genotoxicity Studies | |
|
S2(R1)
|
Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use |
| Toxicokinetics and Pharmacokinetics | |
|
S3A
|
Note for Guidance on Toxicokinetics : the Assessment of Systemic Exposure in Toxicity Studies |
|
S3B
|
Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies |
| Toxicity Testing | |
|
S4
|
Single Dose Toxicity Tests Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing) |
| Reproductive Toxicology | |
|
S5(R2)
|
Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility |
| Biotechnological Products | |
|
S6
|
Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
| Pharmacology Studies | |
|
S7A
|
Safety Pharmacology Studies for Human Pharmaceuticals |
|
S7B
|
The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) By Human Pharmaceuticals |
| Immunotoxicology Studies | |
|
S8
|
Immunotoxicology Studies for Human Pharmaceuticals |
|
S9
|
Nonclinical Evaluation for Anticancer Pharmaceuticals |
| Photosafety Evaluation | |
|
S10
|
Photosafety Evaluation of Pharmaceuticals |
TOP |
| Clinical Safety | |
|
E1
|
The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions |
|
E2A
|
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting |
|
E2B/R2
|
Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports |
|
E2C(R1)
|
Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs |
|
E2D
|
Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting |
|
E2E
|
Pharmacovigilance Planning |
|
E2F
|
Development Safety Update Report |
| Clinical Study Reports | |
|
E3
|
Structure and Content of Clinical Study Reports |
| Dose-Response Studies | |
|
E4
|
Dose-Response Information to Support Drug Registration |
| Ethnic Factors | |
|
E5(R1)
|
Ethnic Factors in the Acceptability of Foreign Clinical Data |
| Good Clinical Practice | |
|
E6(R1)
|
Good Clinical Practice |
| Clinical Trials | |
|
E7
|
Studies in Support of Special Populations: Geriatrics |
|
E8
|
General Considerations for Clinical Trials |
|
E9
|
Statistical Principles for Clinical Trials |
|
E10
|
Choice of Control Group and Related Issues in Clinical Trials |
|
E11
|
Clinical Investigation of Medicinal Products in the Pediatric Population |
| Guidelines for Clinical Evaluation by Therapeutic Category | |
|
E12
|
Principles for Clinical Evaluation of New Antihypertensive Drugs |
| Clinical Evaluation | |
|
E14
|
The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs |
| Pharmacogenomics | |
|
E15
|
Definitions
for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories |
|
E16
|
Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions |
TOP |
|
M1
MedDRA |
Medical Dictionary for Regulatory Activities |
|
M2 |
Electronic Standards for the Transfer of Regulatory Information |
|
M3(R2)
|
Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals |
|
M4
CTD |
The Common Technical Document |
|
M5
|
Data Elements and Standards for Drug Dictionaries |
|
M6
|
Virus and Gene Therapy Vector Shedding and Transmission |
|
M7
|
Genotoxim Impurities |
|
M8
|
Electronic Common Technical Document (eCTD) |
Page updated 11 January 2011
