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SEMINAR ON BY MOHD. SHARIQ ANSARI DEPARTMENT OF PHARMACOLOGY H.S.K. COLLEGE OF PHARMACY BAGALKOT KARNATAKA ICH GUIDELINES

Table of Contents:

Table of Contents What is ICH History Members Purpose Guidelines Arrivals of ICH References.

What does ICH stand for ?:

What does ICH stand for ? The name of ICH is the “INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ’’ What is ICH? ICH is a joint initiative involving both regulators and research based industry representatives of EU, Japan , and the US in scientific and technical discussions of the testing procedures which are required to ensure and assess the safety, quality, efficacy, and multidisciplinary of medicines.

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History Formation of ICH :1990 ICH 1 : Brussels, Belgium, November 1991 ICH 2 : Orland, USA, October 1993 ICH 3 : Yokohama, Japan, November 1995 ICH 4 : Brussels, Belgium, July 1997 ICH 5 : San Diego, USA, November 2000 ICH 6 : Osaka, Japan, November 2003 ICH 7 : It was cancelled

Who are the members ? ICH is comprised of representatives from six co -sponsored parting as well as three observers and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) a) Japan : the Ministry of Health & Welfare (MHW) and the Japan Pharmaceutical Manufacturers Association (JPMA) b) EU : the European Commission (EC) and the European Federation of Pharmaceutical Industries’ Associations (EFPIA) c) USA : the food & Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) d) Observers : WHO, EFTA, and Canada:

Who are the members ? ICH is comprised of representatives from six co -sponsored parting as well as three observers and the International Federation of Pharmaceutical Manufacturers Association (IFPMA) a) Japan : the Ministry of Health & Welfare (MHW) and the Japan Pharmaceutical Manufacturers Association (JPMA) b) EU : the European Commission (EC) and the European Federation of Pharmaceutical Industries’ Associations (EFPIA) c) USA : the food & Drug Administration (FDA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) d) Observers : WHO, EFTA, and Canada

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What is the purpose of ICH? The objective of ICH is to increase international harmonization of technical requirements to ensure that safe, effective, and high quality medicines are developed and registered in the most efficient and cost effective manner .

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medDRA Management Board Steering Committee Coordinators Secretariat ICH Working Group Global Cooperation Group

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ICH Guidelines ICH has developed over 45 harmonized guidelines The ICH topics are divided into four major categories: 1.) Quality (Q), i.e. those relating to chemical and pharmaceutical Quality Assurance 2.) Safety (S), i.e. those relating to in vivo and in vitro preclinical studies 3.) Efficacy (E), i.e. those relating to clinical studies in human subject 4.) Multidisciplinary topics (M), i.e. cross-cutting topics which do not fit uniquely into one of the above categories

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Quality Guidelines Stability Analytical validation Impurities Pharmacopoeias Quality of Biotechnological products Specification Good Manufacturing Practices Pharmaceutical Development Quality Risk Management

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Safety Guidelines Carcinogenicity Studies Genotoxicity Studies Toxicokinetics and Pharmacokinetics Toxicity Testing Reproductive toxicology Biotechnological Products Pharmacology Studies Immunotoxicology Studies

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Efficacy Guidelines Clinical Safety Clinical Study Reports Dose-Response Studies Good Clinical Practice Clinical Trials Clinical Evaluation By Therapeutics Category Clinical Evaluation Pharmacogenomics Cross-cut Topics

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Efficacy Topics E3: Structure and Content Of Clinical Study Reports E4: Dose Response Information to Support Drug Registration E6: Good Clinical Practice: Consolidated Guideline E8: General Considerations for Clinical Trials E9: Statistical Principles for Clinical Trials E10: Choice of Control Group and Related Issues in Clinical Trials

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Multidisciplinary Guidelines MedDRA (The Medical Dictionary for Regulatory Activities). EDTRI (Electronic Standards for the Transfer of Regulatory Information). Pre-clinical Trials in relation to Clinical Trials. Electronic Common Technical Documents( eCTD ). Data elements and standard for drug dictionary.

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Five Steps in the ICH Process For Harmonization of Technical Issues Step 1: Building Scientific Consensus in Joint Regulatory/Industry Expert Working Groups Step 2: Agreement by the Steering Committee to Release the Draft Consensus Text for Wider Consultation Step 3: Regulatory Consultation in the Three Regions Consolidation of the Comments Step 4: Agreement on Harmonized ICH Guidelines, Adopted by Regulators Step 5: Implementation in the Three ICH Regions

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ICH Terms of Reference To maintain forum for a constructive dialogue between regulatory authorities and the pharmaceutical industry on the real and perceived differences in the technical requirements for product registration in the EU, USA and Japan in order to ensure a more timely introduction of new medicinal products, and their availability to patients To contribute to the protection of public health from an international perspective

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To monitor and update harmonized technical requirements leading to a greater mutual acceptance of research and development data. To avoid divergent future requirements through harmonization of selected topics needed as a result of therapeutics advances and the development of new technologies for the production of medicinal products. To facilitates the adoption of new or improved technical research and development approaches whish update or replace current practices, where these permit a more economical us of human, animals and material resources, without compromising safety. To facilitates the dissemination and communication of information on harmonized guidelines and their use such as to encourage the implementation and integration of common standards.

How ICH arrived at this point:

Technical content Format E3: Content and Format of Clinical Study Reports E2B: Individual Case Safety Reports M4: Common Technical Document M2: Electronic common Technical Document M5: Data Elements and Standards for Drug Dictionary Requirements for Electronic Standards Process Safety of Medicines How ICH arrived at this point

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ICH SDO Process Established methodologies Wider recognition of accreditation

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The 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 U.S, in order to make these products available to patient with minimum of delay. The six parties to ICH represent the regulatory bodies and research-based industry in the three regions viz. Europe, Japan, and the U.S, where the vast majority of new medicines are currently developed. The ICH process has achieved success because it is based on scientific consensus developed between industry and regulatory experts and because of the commitment of the regulatory parties to implement the ICH tripartite, harmonized guidelines and recommendations. Future of ICH-Revised 2000

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The Fifth International Conference on Harmonization (ICH 5) San Diego, November 2000, marks the end of 10 years of activity thus providing an opportunity to evaluate results and to identify future needs in the area of international harmonization.

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Evolving Science in Drug safety and Quality. Brussels, Belgium, November 8-13, 2008 The International Conference on Harmonization (ICH) Steering Committee and its expert working groups met in Brussels. The highlights of the meeting achievement are How tools such as Quality by design could be put into practice Greater understanding of pharmaceutical and manufacturing sciences will create a basis for more flexible regulatory approaches. The Quality Implementation Working Group will answer question arising from the new Q8, Q9 and Q10 guidelines. ICH Steering Committee Meeting

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The Quality guidelines promotes a more conceptual and flexible approach to pharmaceutical quality. Also off note was a meeting of the Q11 Expert Working Group ‘‘ Development and Manufacture of Drug Substance ’’, covering both chemical and biological substances. ‘‘ Non-clinical evaluation of Anti-caner Pharmaceuticals ’’ will be released for public consultation. These pharmaceuticals products intended to treat Cancer in patients with late stage or advance disease. In the field of clinical safety and efficacy, the experts made significant progress in developing ICH Guidelines E16 ‘‘ Genomic Biomarkers Related to drug Response: Context, Structure, and Format of Qualification Submission ’’, which will harmonize and thus facilitate submission of proposals for biomarkers qualification.

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The ICH Steering Committee recognized the benefits of continuing to work with International Standard Development Organizations (SDO) in developing harmonized electronic massages to transfer regulatory information with a view to develop harmonized formats for Individual Case Safety Report (ICSR) and identification of Medicinal Products The process on the evaluation of pharmacopoeial texts aiming at their interchangeability between the ICH region s has been further accelerated. In autumn 2007 the Steering Committee decided to invite representatives of individual Drug Regulatory Authorities from outside the ICH region to participate in the Global Cooperation Group. The Steering Committee was particularly pleased that so many of those invited attended the Brussels meeting, as this promotes a better understanding of the ICH process and guideline development.

Reference:

www.ich.org www.google.co.in Reference

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