Pharmaceutical Guidelines

Pharmaceutical Guidelines
Nazim Hussain Pansuvi
(drnh14@gmail.com)
MHRA

ICH Guidelines
The ICH topics are divided into the four categories below and ICH topic
codes are assigned according to these categories.
Quality Guidelines Safety Guidelines
Efficacy Guidelines Multidisciplinary Guidelines

ICH
Q1 Stability( Q1A-Q1F)
• ICH Q1A (R2) Stability testing of new drug substances and drug products
• ICH Q1B Photostability testing of new active substances and medicinal products
• ICH Q1C Stability testing: requirements for new dosage forms
• ICH Q1D Bracketing and matrixing designs for stability testing of drug substances
and drug products
• ICH Q1E Evaluation of stability data
• ICH Q1F Stability data package for registration in climatic zones III and IV -
explanatory note

ICH
Q2 Analytical Validation
• ICH Q2 (R1) Validation of analytical procedures: text and methodology

ICH
Q3 Impurities
• ICH Q3A (R2) Impurities in new drug substances
• ICH Q3B (R2) Impurities in new drug products
• ICH Q3C (R5) Residual solvents
• ICH Q3D Elemental impurities

ICH
Q4 Regulatory Acceptance
• ICH Q4B Evaluation and recommendation of pharmacopoeial texts for use in the ICH regions
• ICH Q4B Annex 1 Residue on ignition/sulphated ash
• ICH Q4B Annex 2 Test for extractable volume in parenteral preparations
• ICH Q4B Annex 3 Test for particulate contamination: sub-visible particles
• ICH Q4B Annex 4A Microbiological examination of non-sterile products: microbial enumeration tests
• ICH Q4B Annex 4B Test for microbiological examination of non-sterile products: tests for specified
micro-organisms
• ICH Q4B Annex 4C Test for microbiological examination of non-sterile products: acceptance criteria
for pharmaceutical preparations and substances for pharmaceutical use
• ICH Q4B Annex 5 Disintegration test

ICH
Q4 Regulatory Acceptance
• ICH Q4B Annex 6 Uniformity of dosage unites general chapter
• ICH Q4B Annex 7 Dissolution test
• ICH Q4B Annex 8 Sterility test
• ICH 4 QB Annex 9 Tablet friability
• ICH Q4B Annex 10 Polyacrylamide gel electrophoresis
• ICH Q4B Annex 11 Capillary electrophoresis
• ICH Q4B Annex 12 Analytical sieving
• ICH Q4B Annex 13 Bulk density and tapped density of powders
• ICH Q4B Annex 14 Bacterial endotoxins tests

ICH
Q6 Specifications
• ICH Q6A Specifications: test procedures and acceptance criteria for
new drug substances and new drug products: chemical substances
• ICH Q6B Test procedures and acceptance criteria for
biotechnological/biological products

ICH
• ICH Q7 Good manufacturing practice for active pharmaceutical
ingredients
• ICH Q8 (R2) Pharmaceutical development
• Q9 ICH Q9 Quality risk management
• ICH Q10 Pharmaceutical quality system
• ICH Q11 Development and manufacture of drug substances
(chemical entities and biotechnological/biological entities)
• ICH Q12 Technical and regulatory considerations for pharmaceutical
product lifecycle management

ICH
Safety
Carcinogenicity studies
• ICH S1 Regulatory notice on changes to core guideline on rodent
carcinogenicity testing of pharmaceuticals
• ICH S1A Need for carcinogenicity studies of pharmaceuticals
• ICH S1B Carcinogenicity: testing for carcinogenicity of
pharmaceuticals
• ICH S1C (R2) Dose selection for carcinogenicity studies of
pharmaceuticals

ICH
Safety
Genotoxicity studies
ICH S2 (R1) Genotoxicity testing and data interpretation for
pharmaceuticals intended for human use

ICH
Safety
Toxicokinetics and pharmacokinetics
• ICH S3A Toxicokinetics: the assessment of systemic exposure in
toxicity studies
• ICH S3A Toxicokinetics: the assessment of systemic exposure in
toxicity studies - questions and answers
• ICH S3B Pharmacokinetics: repeated dose tissue distribution
studies

ICH
Safety
Repeat-dose toxicity
• ICH S4 Duration of chronic toxicity testing in animals (rodent and
non-rodent toxicity testing)
Reproductive toxicology
• ICH S5 (R2) Reproductive toxicology: detection of toxicity to
reproduction for medicinal products including toxicity to male
fertility
Biotechnological products
• ICH S6 (R1) Preclinical safety evaluation of biotechnology-derived
pharmaceuticals

ICH
Safety
Safety pharmacology studies
• ICH S7A Safety pharmacology studies for human pharmaceuticals
• ICH S7B Non-clinical evaluation of the potential for delayed
ventricular repolarization (QT interval prolongation) by human
pharmaceuticals
Immunotoxicology studies
• ICH S8 Immunotoxicity studies for human pharmaceuticals

ICH
Safety
Therapeutic area-specific
• ICH S9 Non-clinical evaluation for anticancer pharmaceuticals
Photosafety evaluation
• ICH S10 Photosafety evaluation of pharmaceuticals

ICH
Efficacy
Clinical safety
• ICH E1 Population exposure: the extent of population exposure to assess clinical
safety
• ICH E2A Clinical safety data management: definitions and standards for expedited
reporting
• ICH E2B (R3) Electronic transmission of individual case safety reports (ICSRs) -
data elements and message specification - implementation guide
• ICH E2C (R2) Periodic benefit-risk evaluation report
• ICH E2D Post-approval safety data management
• ICH E2E Pharmacovigilance planning (Pvp)
• ICH E2F Development safety update report

ICH
Efficacy
Clinical study report
• ICH E3 Structure and content of clinical study reports
Dose response studies
• ICH E4 Dose response information to support drug registration
Ethnic factors
• ICH E5 (R1) Ethnic factors in the acceptability of foreign clinical data
• ICH E5(R1) Ethnic factors in the acceptability of foreign clinical data -
questions and answers
Good clinical practice
• ICH E6 (R2) Good clinical practice

ICH
Efficacy
Clinical trials
• ICH E7 Studies in support of special populations: geriatrics
• ICH E8 General considerations for clinical trials
• ICH E9 Statistical principles for clinical trials
• ICH E10 Choice of control group in clinical trials
• ICH E11(R1) step 5 guideline on clinical investigation of medicinal products in the
pediatric population
• ICH E17 Guideline on general principles for planning and design of multi-regional
clinical trials
• ICH E18 Guideline on genomic sampling and management of genomic data

ICH
Efficacy
Clinical evaluation by therapeutic category
• ICH E12 Principles for clinical evaluation of new antihypertensive drugs
Clinical evaluation
• ICH E14 Clinical evaluation of QT/QTc interval prolongation and proarrhythmic
potential for non-antiarrhythmic drugs
• ICH E14 (R3) Clinical evaluation of QT/QTc interval prolongation and
proarrhythmic potential for non-antiarrhythmic drugs - questions and answers
• ICH E15 Definitions for genomic biomarkers, pharmacogenomics,
pharmacogenetics, genomic data and sample coding categories
• ICH E16 Genomic biomarkers related to drug response: context, structure and
format of qualification submissions

ICH
Multidisciplinary
M1 MedDRA Terminology
• M1 MedDRA-Medical Dictionary for Regulatory Activities (MedDRA)
• M1 PtC WG MedDRA points to considers
M2 Electronic Standards
• M2 EWGElectronic Standards for the Transfer of Regulatory Information
M3 Nonclinical Safety Studies
• M3(R2)Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical
Trials and Marketing Authorization for Pharmaceuticals
• M3(R2) Q&As (R2)Questions & Answers: Guidance on Nonclinical Safety Studies
for the Conduct of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals

ICH
Multidisciplinary
• M8 Electronic Common Technical Document (eCTD)
• M9 Biopharmaceutics Classification System-based Biowaivers
• M10 Bioanalytical Method Validation and Study Sample Analysis
• M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)
• M12 Drug Interaction Studies
• M13 Bioequivalence for Immediate-Release Solid Oral Dosage
Forms
• M14 Use of real-world data for safety assessment of medicines
• M15 General Principles for Model-Informed Drug Development

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