PROCESS OF ICH (International Council for Harmonisation)

In this slides contain a ICH guidelines process and information about the organization. https://www.ich.org/

1. PROCESS OF ICH PRESENTED BY SWATHI.P DEPARTMENT OF PHARMACEUTICAL QUALITY ASSURANCE JSS COLLEGE OF PHARMACY,OOTY.

2. OVERVIEW OF ICH HARMONIZATION

3. WHAT IS ICH “Technical Requirements for registration of pharmaceuticals for human use”. Ensure and assess the safety, quality & efficacy of medicines. HISTORY Joint initiative involving regulators & industry In the scientific & technical discussions of the testing procedures The birth of ICH took place at meeting in April 1990 in Brussels. The International Conference on Harmonisation has renamed itself as the International Council on Harmonisation on 23october 2015. This changes will help to expand its membership, which includes pharmaceutical regulators from US, EU, Japan, Canada and Switzerland.

4. PURPOSE OF ICH Harmonization of technical requirements. Ensure safety, efficacy and quality of medicines. Prevent duplication of clinical trials in humans. Minimize the use of animal testing without compromising safety and effectiveness. Achieving greater harmonization In the interpretation and application of technical guidelines and Requirements for pharmaceutical product registration. MISSION

5. Continu.. To maintain forum for a constructive dialog on scientific issues. To contribute to the protection of public health To monitor and update harmonised technical requirements regarding acceptance and research data. To avoid divergent future requirements through harmonisation of selected topics To encourage the implementation and integration of common standards. To develop the policy for the ICH Medical Dictionary for Regulatory Activities Terminology (MedDRA) To facilitate the adoption of new or improved technical research and development approaches.

6. INITIATION OF ICH Harmonization of regulatory requirements was pioneered by European community(Now EU) in 1980s. Success achieved by Europe demonstrated that harmonisation was feasible. At same time there were bilateral discussions between Europe, Japan & US, on possibilities for harmonization. Topics selected for harmonization Safety Quality & Efficacy

7. EVOLUTION OF ICH Two decades of success, attributed by scientific consensus & the commitment between industry and regulatory parties. First decade saw significant progress in the development of tripartite ICH guidelines on SAFETY, QUALITY & EFFICACY topics and also on Multidisciplinary topics (MedDRA, CTD). Expanded communication & dissemination of information on ICH guidelines with Non-ICH regions. Second decade towards facilitating the implementation of ICH Guidelines in ICH and maintaining already existing ICH Guidelines. Est. Global cooperation Group (GCG)-in response to a growing interest from beyond the ICH region in the use of ICH guidelines.

8. ORGANIZATION

9. STEERING COMMITTEE Governing body that overseas the harmonization activities Six co-sponsors has two seats on the SC(EU, EFPIA, MHLW, JPMA, USFDA, PhRMA) 3 Observers are WHO, Health Canada, European Free trade Association (EFTA) The IFPMA host the secretariat & participates as a non-voting member

10. GCG & MedDRA MANAGEMENT BOARD Global Cooperation Group represents from 5 Regional Harmonization Initiatives (RHI’s) APEC, ASEAN, EAC, GCC, PANDRH, SADC’. MedDRA management Board:-Overall responsibility for direction of MedDRA MedDRA and ICH standardized dictionary of medical terminology The board overseas the activities of MedDRA “Maintenance and Support Services” (MSSO) which serves as the repository, maintainer, developer and distributor of MedDRA.

11. GLOBAL COOPERATION GROUP Formed in 1999 Sub-committee of SC Participants:

12. MedDRA Medial dictionary of regulatory activities MedDRA is registered trademark of IFPMA MedDRA is free to regulatory authorities, academic, healthcare providers It is used in 60 countries & available in II different languages Prepared by ICH and owned by IFPMA Used for registration, documentation and safety monitoring of medical products MSSO is responsible to maintain, develop and distribute MedDRA

13. MedDRA MANAGEMENT BOARD Overseas the activities of the MedDRA “Maintenance and Support Services Organization” (MSSO) Members

14. SECRETARIAT AND COORDINATORS Secretariat located in Geneva, Switzerland, operating from IFPMA officers. Secretariat staff is responsible for day to day management of ICH, namely preparations for & documentation of, meetings of the SC and its working group Coordinators: fundamental to the smooth running of ICH, Acts as a main contact point with the ICH secretariat. To combat H5N1 pandemic threat IFPMA’s research-based vaccine manufacturing members are conducting a growing number of clinical trials of ‘prototype’ influenza vaccines, designed to counter to the threats of avian and pandemic influenza.

15. WHAT IS AN ICH WORKING GROUP? Depending on the type of harmonization activity needed, the steering committee will endorse the establishment of one of three types of working group i.e., Expert Working Group (EWG) , Implementation Working group (IWG) or Informal Working Group Discussion Group

16. ICH WORKING GROUP There are several different types of ICH working groups. EWG: developing a harmonized guideline that meets the objectives in the concept paper and business plan IWG: develop Q & A to facilitate implementation of existing guidelines InWG: developing/finalizing a concept paper, as well as developing a business plan DG: discuss specific scientific considerations and views

17. PROCESS OF HARMONIZATION

18. FORMAL ICH PROCEDURE

19. Q&A PROCEDURE It is followed when additional guidance is necessary Additional guidance is developed in form of Q&As The procedure is initiated with endorsement by the ICH Assembly of concept paper An Implementation Working Group is established REVISION PROCEDURE Followed when content of existing ICH Guideline is no longer up-to-date or valid Or in case where new information is needed to be added with no amendments The new information is added in the form of Addendum or an Annex An Expert Working Group (EWG) is established

20. MAINTENANCE PROCEDURE It is applicable only for changes to the Q3C and Q3D and M2 Recommendations This procedure is used when the technical content is out-of-date Maintenance procedure for Q3C and Q3D Followed when there is “Permitted daily exposure” (PDE) for new solvent/elemental impurity or revised PDA for an already classified solvent/elemental impurity.

21. WORK PRODUCTS ICH Guidelines MedDRA CTD (Common Technical Document) Electronic Standards Consideration Documents Open Consultants

22. BENEFITS OF ICH PROCESS More then 50 harmonized guidelines Streamlined R & D process Rapid access to new regulators Benefits for the regulators Reference and educational material for non-ICH members Expanded participation in the development and implementation of ICH products will play a key role in promoting a more globally consistent approach to drug development and oversight

23. ICH GUIDELINES

24. QUALITY GUIDELINES stability studies, determining 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 - Q3D Impurities Q4 - Q4B Pharmacopoeias Q5A - Q5E Quality of Biotechnological Products Q6A- Q6B Specifications Q7 Good Manufacturing Practice Q8 Pharmaceutical Development Q9 Quality Risk Management Q1O 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

25. SAFETY GUIDELINES ICH has prepared a comprehensive set of safety guidelines to reveal potential risks like carcinogenicity, reprotoxicity and genotoxicity. 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 S10Photosafety Evaluation S11 Nonclinical Paediatric Safety

26. EFFICACY GUIDELINES The efficacy guidelines are concerned with the design, carrying, and safety and reporting of clinical trials. 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 E19Safety Data Collection E20 Adaptive Clinical Trials

27. MULTIDISCIPLINARY GUIDELINES Multidisciplinary guidelines describes about Common Technical Document (CTD), medical terminology (MedDRA), 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 M6 Gene Therapy M7 Mutagenic impurities M8 Common Technical Document (eCTD) M9 Biopharmaceutics Classification System-based Biowaivers M10 Bioanalytical Method Validation M10 Clinical electronic Structured Harmonised Protocol (CeSHarP) M12 Drug Interaction Studies

28. CONCLUSION As the pharmaceutical industry growing globally day by day, there is a great need of developing guidelines those will create harmonization. ICH is formed to develop and implement harmonised guidelines that will reduce the time required for registration of a pharmaceutical product. ICH guidelines are mainly categorised into four types (Quality, Safety, Efficacy, and Multidisciplinary ) which will cover almost all areas required for registration of a pharmaceutical product .

29. REFERENCE PROCESS OF ICH HARMONIZATION . https://www.ich.org/home.html