ICH GUIDELINES OF ICH–QSEM detailed.pptx

ICH Guidelines of Quality, Safety, Efficacy and Multidisciplinary guidelines that implemented by International Council for Harmonisation. ich stands for the harmonisation of Technical requirements of Pharmaceuticals for Human use.

1. ICH GUIDELINES OF ICH – Q,S,E,M SUBJECT : REGULATORY AFFAIRS Presented by; NISHANTH K P 1 st Semester M.Pharm (Pharmaceutics) Nazareth College of Pharmacy 1

2. contents INTRODUCTION NEED FOR HARMONISE ORIGIN OF ICH EVOLUTION OF ICH OBJECTIVES OF ICH PARTICIPANTS OF ICH PROCESS OF ICH ICH GUIDELINES ON Q,S,E,M 2

3. INTRODUCTION ICH stands for “International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use” Which is international non-profit Association which is unique in bringing together the regulatory authorities and pharmaceutical industries. Where European Union, Japan and the USA involve in scientific and technical discussions of the testing procedures required to assess and ensure the safety, quality and efficacy of medicines. These are the three pillars on which the health of the patients depend. 3

4. ICH Guidelines accepted as law in several Countries to ensure access the Q, S, E of medicines but are only used as guidance for the U.S Food and Drug Administration. Each regulatory co-sponsor implements the guidelines according to its National or Regional requirements. They are intended to be used in combination with any regional requirements. 4

5. Need to harmonize Many time consuming and expensive test procedures, in order to market new products, internationally. Over rising costs of health care making safe and efficacious new treatments available to patients in need. Divergence in technical requirements from country to country. 5

6. Origin of ich Harmonization of regulatory requirements was pioneered by the EU, Europe, in the 1980s as the Europe move towards the development of single market. The success achieved in Europe demonstrated that harmonization was feasible. At the same time there were discussions between Europe, Japan and the US on possibilities for harmonization. The birth of ICH took place at a meeting in April 1990. Topics selected for harmonisation would be divided into safety, quality and efficacy to reflect the three criteria which are the basis for approving and authorising new medicinal products. 6

7. evolution of ich First decade: Significant progress in the development of ICH guidelines on Safety, Quality and Efficacy topics and also work on a number of important multidisciplinary topics. Second decade: Implementation of ICH guidelines in the ICH regions. Expand communication and information on ICH guidelines with other regions. Third decade: Extending the benefits of harmonization beyond the ICH regions. Training, as well as active participation of other regions in guideline development is seen as key in this effort. 7

8. Objectives of ich Promote public health by early availability of drug in the market. Maintaining safeguards on quality, safety and efficacy. Improve efficiency of new drug development, Reduce registration cost. Less expensive drugs for patients. Prevent the duplication of clinical trails in humans. Minimize the animal use with out compromising in safety, efficacy of the product. Mutual acceptance of clinical data by regulatory authority. Reducing testing duplication. 8

9. Participants of Ich ICH comprises of 6 parties which represent the industry and regulatory bodies in EU, Japan and USA. The 6 co-sponsors of ICH are; European Commission European Federation of Pharmaceutical Industries and Association (EFPIA) Ministry of Health Labour and Welfare (Japan) Japan Pharmaceutical Manufactures Association (JPMA) Food and Drug Administration (FDA) Pharmaceutical Research and Manufactures of America (PHRMA) 9

10. Participants of Ich There are 3 observers which represent the non-ICH regions and countries. World Health Organization (WHO) Canada – Health Canada European Free Trade Association (EFTA) An additional non-voting member of the ICH is International Federation of Pharmaceutical Manufactures Association (IFPMA) ; It comprises of representatives from research based industry and other manufactures of prescription medicines in 56 countries. 10

11. Ich process STEPS OF ICH HARMONIZATION 11 STEP 1 :- Building Scientific Consensus STEP 2 :- Agreeing on Draft Text STEP 3 :- Consulting Regional Regulatory Agencies STEP 4 :- Adopting Harmonized Guidelines STEP 5 :- Implementing Guidelines in ICH Regions

12. Ich guidelines The guidelines of ICH are broadly categorized into 4 types; Quality guidelines (Q 1 - Q 14 ) : Chemical & Pharmaceutical QA Safety guidelines (S 1 - S 12 ) : Deal with in vitro- in vivo preclinical testing Efficacy guidelines (E 1 - E 21 Except E 13 ) : Clinical study in human beings Multidisciplinary guidelines (M 1 - M 15 ) : Terminology, electronic standards, documentation 12

13. Quality guidelines Harmonisation achievements in the Quality area include pivotal milestones such as the conduct of stability studies, defining relevant thresholds for impurities testing and a more flexible approach to pharmaceutical quality based on Good Manufacturing Practice (GMP) risk management. Q1A-Q1F : Stability Q2 : Analytical Validation Q3A-Q4B : Pharmacopoeias Q5A-Q5E : Quality of Biotechnological Products Q6A-Q6B : Specifications 13

14. Quality guidelines Q7 : Good Manufacturing Practice Q8 : Pharmaceutical Development Q9 : Quality Risk Management Q10 : Pharmaceutical Quality System Q11 : Development and Manufacture of Drug Substances Q12 : Life cycle management Q13 : Continuous Manufacturing of Drug Substances and Drug Products Q14 : Analytical Procedure Development 14

15. safety guidelines ICH has produced a comprehensive set of safety Guidelines to uncover potential risks like carcinogenicity, genotoxicity and reprotoxicity . A recent breakthrough has been a non-clinical testing strategy for assessing the QT interval prolongation liability: the single most important cause of drug withdrawals in recent years. S1A-S1C : Carcinogenicity studies S2 : Genotoxicity Studies S3A-S3B : Toxicokinetics and Pharmacokinetics S4 : Toxicity Testing S5 : Reproductive Toxicology 15

16. safety guidelines 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 16

17. efficacy guidelines The work carried out by ICH under the efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/ Pharmacogenomics techniques to produce better targeted medicines. E1 : Clinical Safety for Drugs used in Long Term Treatment E2A-E2F : Pharmacovigilance E3 : Clinical study Reports E4 : Dose Response studies E5 : Ethnic Factors 17

18. efficacy guidelines 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 18

19. efficacy guidelines 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 E21 : Inclusion of Pregnant and Breastfeeding individuals in Clinical 19

20. Multidisciplinary guidelines Those are the cross cutting topics which do not fit uniquely into one of the Quality, Safety and Efficacy categories. It includes the ICH medical terminology (MedDRA), the Common Technical Document (CTD) and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI). M1 : MedDRA Terminology M2 : Electronic standards M3 : Nonclinical Safety Studies M4 : Common Technical Document M5 : Data Elements and Standards for Drug Dictionaries 20

21. multidisciplinary guidelines M6 : Gene Therapy M7 : Mutagenic Impurities M8 : Electronic Common Technical Document 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 21

22. references https://www.ich.org/page/ich-guidelines https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/ich-guidance-documents https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/scientific-guidelines/ich-guidelines/ich-quality 22

23. Thank you 23