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ICH Guidelines For The Assessment of Herbal Drug Notes B.Pharm 6th Semester

Notes on ICH Guidelines For The Assessment of Herbal Drug

Herbal Drug Technology

B.Pharmacy 6th Semester

ICH Guidelines For The Assessment of Herbal Drug HERBAL DRUG TECHNOLOGY HK TECHNICAL PGIMS 1Evaluation of Drugs Assessment/Evaluation/Standardization of drug means confirmation of its identity and determination of its quality, purity and detection of nature of adulterant by various parameters like morphological, microscopical, physical, chemical and biological observations. The evaluation of herbal drugs is necessary because of three main reasons a) Biochemical variation in the drug b) Deterioration due to improper processing and storage. c) Adulteration and substitution. HK TECHNICAL PGIMS 2ICH Guideline The full name of ICH is: “International Conference on Harmonization” Of Technical Requirements for Registration of Pharmaceuticals for Human Use. Also Known as ICH Tripartite Guidelines HK TECHNICAL PGIMS 3Introduction to ICH  Patient taking a medicine, drug or pharmaceutical product expect the product to be safe and efficacious.  Pharmaceutical agencies world wide demand the product to retain its identity, quality, purity and potency for the time product is commercially available. HK TECHNICAL PGIMS 4Introduction to ICH The International conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan and the United States, in order to make these products available to patients with a minimum of delay. HK TECHNICAL PGIMS 5Role of ICH in assessment of herbal drugs  ICH is the international council of harmonization of technical requirement for pharmaceutical for human use.  ICH is the link between regulatory bodies and pharmaceutical Industry. Regulatory Body Pharma Industry ICH Guidelines HK TECHNICAL PGIMS 6Goals of ICH Guidelines ICH mainly involves the testing to assess and ensure the  Safety,  Quality and  Efficacy of medicines and related products. Goals of ICH  To decrease country to country difference in guidelines  To decrease the difference between regulatory authorities HK TECHNICAL PGIMS 7Goals of ICH Guidelines  Related to pharmaceutical Industry  To achieve harmonization worldwide for sale, effective and high quality medicines  ICH brings uniformity through the world and development of guidelines which involves experts from regulatory fields and industry  Drug development, formulation analytical method development, stability testing, clinical trials and other activities related to herbal drugs are done according to ICH guidelines  Results in good quality of herbal drugs. HK TECHNICAL PGIMS 8Objective of ICH  To increase international harmonization technical requirements to ensure that safe, effective, and high quality medicines.  Development and registration of these drugs in the most efficient and cost effective manner.  Aim to produce a single set of technical requirements for the registration of new drug.  Prevent unnecessary duplication of clinical trials of humans  Eliminate unnecessary delays in the availability of new medicine  Promote public health. HK TECHNICAL PGIMS 9Members of ICH ICH is comprised of 6 Representatives from the six co-sponsoring parties  Japan: The Ministry of Health & Welfare (MHW) and Japan Pharmaceutical Manufactures Association (JPMA)  Europe: European Commission (EC) and European Federation of Pharmaceutical Industries Associations (EFPIA)  USA  Food and Drug Administration (FDA)  Pharmaceutical Research and Manufacturers of America (PhRMA) HK TECHNICAL PGIMS 10ICH Observer Three Observers to act as a link with non-ICH countries and regions. The ICH Observers are:  The World Health Organization (WHO)  The European Free Trade Association (EFTA), currently represented at ICH by Swiss medic Switzerland  Canada, represented at ICH by Health Canada HK TECHNICAL PGIMS 11Categories of ICH Guidelines QSEM  Quality guidelines includes stability-Analytical validation-Quality of biotechnological product GMP-Pharmaceutical development-Development and manufacturing of drug substances  Safety guidelines includes pharmacological studies-immunotoxicity studies-photo safety evaluation and non clinical paediatric safety  Efficacy guidelines includes design conduct safety and reporting of clinical trials, good clinical practices, novel medicines derives from biotechnological processes, pharmacogenetics and pharmacogenomics techniques  Multidisciplinary guidelines Includes ICH medical terminology (MedDRA). The common technical document (CTD). The development of electronic standards for the transfer of regulatory information (ESTRI)Bio analytical method validation HK TECHNICAL PGIMS 12Safety Guidelines  ICH has produced a set of safety Guidelines to uncover risks like carcinogenicity, genotoxicity and reprotoxicity.  In all there are 15 safety guidelines from S1 to S15  S1 – Carcinogenic study  S2 – Genotoxicity study  S3 – Toxicokinetics & Pharmacokinetics  S4 – Toxicity testing  S5 – Reproductive Toxicology  S6 – Biotechnological Products  S7 – Pharmacological studies  S8 & S9 – Immunotoxicology studies HK TECHNICAL PGIMS 13Efficacy Guidelines  The work carried out by ICH under the Efficacy 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/genomics techniques to produce better targeted medicines.  In all there are 18 Efficacy guidelines from E1 to E18  E1 & E2 – Clinical safety  E3 – Clinical study Report  E4 – Dose Reponse study  E5 – Ethnic factors  E6 – Good Clinical Practices.  E7-E11-Clinical trials  E12- Clinical Evaluation  E14 – Clinical Evaluation  E15 & E16 – pharmacogenomics HK TECHNICAL PGIMS 14Quality Guidelines  Harmonization achievements in the quality area includes 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. HK TECHNICAL PGIMS 15Quality Guidelines  In all there are 24 Quality guidelines  Q1-Stability testing  Q2-Analytical method Validation  Q3 – Impurity testingQ4-Pharmacoepial Harmonization  Q5- Biotechnological Products  Q6-Specification of new drug  Q7-Good Manufacturing Products  Q8 – Pharmaceutical Development  Q9-Quality Risk Management  Q10 – Pharmaceutical Quality System HK TECHNICAL PGIMS 16Multidisciplinary Guidelines  Those are the cross-cutting topics which do not fit uniquely intoone 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)  In all there are 05 Multidisciplinary guidelines  M1-Medical terminology  M2 – Electronic Standards for the Transfer of Regulatory Information  M3 – Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals.  M4 – The Common Technical Document.  M5 – Data Elements and Standards for Drug Dictionaries. HK TECHNICAL PGIMS 17Disadvantages  ICH covered new drug substances and products only  WHO developed “separate guideline for stability testing of established drugs in conventional dosage forms”  US FDA went ahead and came out “Stability Testing of solid oral dosage forms, Drugs Containing Iron…” HK TECHNICAL PGIMS 18Thank You HK TECHNICAL PGIMS 19Reference  https://youtu.be/a6ebuZ64Z9s HK TECHNICAL PGIMS 2

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