Recommended
More Related Content
Similar to ICH and Overview of ICH Guidelines..pptx
Similar to ICH and Overview of ICH Guidelines..pptx (20)
Recently uploaded
Recently uploaded (20)
ICH and Overview of ICH Guidelines..pptx
- 1. ICH & ICH Guidelines By: Syed Arshiya M. Pharmacy (Pharmaceutical Regulatory Affairs)
- 2. Introduction: • ICH stands for “International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use”. • It is an initiative that brings together Regulatory authorities and Pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product development and registration.
- 3. History: • In the 1980s the European Union began harmonising regulatory requirements. • In 1989 Europe, Japan & United States began creating plans for harmonisation. • ICH was founded in April 1990 at a meeting in Brussels.
- 4. Mission: • To achieve greater harmonisation world wide. • To protect the public health. • To ensure that safe, effective, and high quality medicines are developed and registered in the most efficient manner. • To monitor and update harmonised technical requirements leading to a greater acceptance of research and development data.
- 5. • To maintain a forum for on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical products.
- 6. Organisation/Structure: The ICH comprises the following bodies: ◦ ICH Assembly ◦ ICH Management Committee ◦ MedDRA Management Committee ◦ ICH Secretariat
- 8. Members & Observers: Founding Regulatory Members: ◦ EC, Europe ◦ FDA, United States ◦ MHLW/PMDA, Japan Standing Regulatory members: ◦ Heath Canada, Canada ◦ Swissmedic, Switzerland
- 9. Regulatory Members: ANVISA, Brazil COFEPRIS, Mexico EDA, Egypt HSA, Singapore MFDS, Republic of Korea MHRA, UK NMPA, China
- 10. SFDA, Saudi Arabia TFDA, Chinese Taipei TITCK, Turkiye Standing Observers: ◦ IFPMA ◦ WHO
- 11. ICH Guidelines: The ICH topics are divided into the four categories below and ICH topic codes are assigned according to these categories: Q – Quality guidelines S – Safety guidelines E – Efficacy guidelines M – Multidisciplinary guidelines
- 12. Quality Guidelines: Guideline Code Title Q1A – Q1F Stability Q2 Analytical validation Q3A – Q3E Impurities Q4A – Q4B Pharmacopoeias Q5A – Q5E Quality of biotechnological products Q6A – Q6B specifications Q7 Good manufacturing practice
- 13. 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. Safety Guidelines: Guideline code Title S1A – S1C Carcinogenicity studies S2 Genotoxicity studies S3A – S3B Toxicokinetics and pharmacokinetics S4 Toxicity testing S5 Reproductive toxicology S6 Biotechnology products
- 15. S7 Pharmacology studies 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. Efficacy Guidelines: Guideline code Title E1 Clinical safety for drugs used in long term treatment E2A – E2F Pharmacovigilance E3 Clinical study reports E4 Dose-response studies E5 Ethic factors E6 Good clinical practice E7 Clinical trails in geriatric population
- 17. E8 General considerations for clinical trails E9 Statistical principles for clinical trails E10 Choice of control group in clinical trails E11 – E11A Clinical trails in paediatric population E12 Clinical evaluation by therapeutic category E14 Clinical evaluation E15 Definitions in pharmacogenetics/ pharmacogenomics E16 Qualification of genomic biomarkers
- 18. E17 Multi regional clinical trails E18 Genomic sampling E19 Safety data collection E20 Adaptive clinical trails E21 Inclusion of pregnant and breastfeeding individuals in clinical trails
- 19. Multidisciplinary Guidelines: Guideline code Title M1 MedDRA terminology M2 Electronic standards M3 Non clinical safety studies M4 Common technical document M5 Data elements and standards for drug dictionaries M6 Gene therapy M7 Mutagenic impurities
- 20. M8 Electronic common technical document (eCTD) M9 Biopharmaceutics classification system based biowavers M10 Bioanalytical method validation and study sample analysis M11 Clinical electronic structured harmonised protocol (CeSHarP) M12 Drug interaction 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
- 22. THANK YOU