Pharmaceutical Guidelines

This presentation covers the ICH guidelines coding no in details.

1. Pharmaceutical Guidelines Nazim Hussain Pansuvi ([email protected]) MHRA

2. Pharmaceutical Guidelines 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

3. Pharmaceutical 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

4. Pharmaceutical Guidelines ICH Q2 Analytical Validation ICH Q2 (R1) Validation of analytical procedures: text and methodology

5. Pharmaceutical Guidelines 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

6. Pharmaceutical Guidelines 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

7. Pharmaceutical Guidelines 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

8. Pharmaceutical Guidelines 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

9. Pharmaceutical Guidelines 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

10. Pharmaceutical Guidelines 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

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

12. Pharmaceutical Guidelines 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

13. Pharmaceutical Guidelines 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

14. Pharmaceutical Guidelines 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

15. Pharmaceutical Guidelines 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

16. Pharmaceutical Guidelines ICH Safety Therapeutic area-specific ICH S9 Non-clinical evaluation for anticancer pharmaceuticals Photosafety evaluation ICH S10 Photosafety evaluation of pharmaceuticals

17. Pharmaceutical Guidelines 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

18. Pharmaceutical Guidelines 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

19. Pharmaceutical Guidelines 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

20. Pharmaceutical Guidelines 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

21. Pharmaceutical Guidelines 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

22. Pharmaceutical Guidelines 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