ich

ICHHarmonization for Better Health

Benhur Pradeep

http://www.myclinicalresearchbook.blogspot.com


ICH Mission Need to Harmonize Initiation of ICH Structure Observers Organization Process of Harmonization Work Products The Guidelines – Q S E M

Outline


The purpose of clinical research is to create knowledge needed to improve healthcare. Without such knowledge, action for healthcare may be impossible, wasteful, expensive or harmful because it will have no logical or empirical basis.


International conference on Harmonization

It is a joint initiative involving regulators & industry as equal partners in the scientific & technical discussions of the testing procedures which are required to ensure and assess the safety, quality & efficacy of medicines.

ICH (April 1990)


To make recommendations towards acheiving greater harmonization in the interporetation and application of technical guidelines and requirements for pharmaceutical product registration, there by reducing duplicating of testing carries out during the research & development of new human medicines.

Mission


Realisation was driven by tragedies, such as that with thalidomide in Europe in the 1960s.

The 1960s and 1970s saw a rapid increase in laws, regulations and guidelines for reporting and evaluating the data on safety, quality and efficacy of new medicinal products.

Divergence in technical requirements from country to country

Need to Harmonize


Harmonization of regulatory requirements was pioneered by European Community (Now EU)

Success acheived by Europe demonstrated that harmonization was possible

At same time there were bilateral discussions between Europe, Japan & US, on possibilites for harmonization

The birth of ICH took place at meeting in April 1990 in Brussels Topics selected for harmonization –

- SAFETY - QUALITY & - EFFICACY

Initiation of ICH


Two decades of success, attributed by scientific concensus & the commitment between industry and regulatory parties.

First decade saw significant progress in the development of tripartitie ICH guidelines on SAFETY, QUALITY & EFFICACY topics and also on Multidisciplanary topics (MedDRA, CTD)

Expanded communication & dessemination of information on ICH guidelines with Non-ICH regions

Estb. Global Cooperation Group (GCG) – in response to a growing interest from beyond the ICH region in the use of ICH guidelines

Evolution of ICH


Structure

Regulatory Body

European Union (EU)

Ministry of Health, Labor and Welfare,

Japan (MHLW)

US Food & Drug

Administration (US-FDA)

Industry

European Federation of

Pharmaceutical Industries

Associations (EFPIA)

Japan Pharmaceutical

Association (JPMA)

Pharmaceutical Research &

Manufactures of America (PhRMA)


WHO, EFTA (European Free Trade Association), Canada, Austrila – Non voting members

IFPMA (International federations of Pharmaceutical Manufactures Association) representative

Observers


Organization


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 ICH secretarist & participartes as a non-voting

member

Steering Committee


Global Cooperation Group represents from 5 Regional Harmonnizational Initatives (RHI‘s) APEC, ASEAN, EAC, GCC, PANDRH, SADC

MedDRA mngt. Board:- Overall responsibility for direction of MedDRA.

MedDRA an ICH stansardised dictonary of medical terminology The board oversees the activites of MedDRA “Maintenance and

Support Services“ (MSSO) which serves as the repository, maintainer, developer and distributor of MedDRA

GCG & MedDRA Management Board


Secretariat located in Geneva, Switzerland, operating from IFPMA offices

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

Secretariat & Coordinators


Each party establishes a contact network of experts with in their own organization or region in order to ensure that, in the discussions they reflect the views & policies of the co-sponsor they represent

There are several different types of ICH working groups- EWG: Expert Working Group- IWG: Implementation Working Group- Informal Working Group- Discussion Group

ICH Working Groups


ICH harmonization activities fall into 4 categories- 1. Formal ICH Procedure: New topic for Harmonization- 2. Q&A Procedure: Clarification on existing guideline- 3. Revision Procedure - 4. Maintenance Procedure

Process of Harmonization


1. ICH Guidelines 2. MedDRA 3. CTD 4. Electronic Standards 5. Consideration Documents 6. Open Consultations

Work Products


Quality (Q1-Q11) - chemical & Pharmaceutial QA

Safety (S1-S10,M3) - dealing with invitro & invivo preclinical testing

Efficacy (E1-E16, Except E13) - clinical studies in human beings

Multidiscilplinary (M1-M8) - terminology, electronic standards, common documents

The Guidelines – Q S E M


Q1-Stability Q2-Analytical Validation Q3-Impurities Q4-Pharmacopoeias Q5-Quality of Biotechnological Products Q6-Specifications Q7-Good Manufacturing Practice Q8-Pharmaceutical Development Q9-Quality Risk Management Q10-Pharmaceutical Quality System

Quality


S1-Carcinogenicity Studies S2-Genotoxicity Studies S3-Toxicokinetics and Pharmacokinetics S4-Toxicity Testing S5-Reproductive Toxicology S6-Biotechnological Products S7-Pharmacology Studies S8-Immunotoxicology Studies S9-Nonclinical evaluation for anticancer pharmaceuticals S10-Photosafety Evaluation

Safety


E1&E2-Clinical Safety E3-Clinical Study Reports E4-Dose-Response Studies E5-Ethnic Factors E6-Good Clinical Practice E7,E8,E9,E10&E11-Clinical Trials E12-Guidelines for Clinical Evaluation by Therapeutic Category E14-Clinical Evaluation E15&E16-Pharmacogenomics

Efficacy


M1-MedDRA Terminology M2-Electronic Standards M3-Non-clinical Safety Studies M4-CTD M5-Data elements & Standards for Drug dictonaries M6-Gene Theraphy M7-Genotoxic Impurities M8-eCTD

Multidisciplinary


ICH launched 20 years ago ICH brings together the drug regulatory authorities of Europe,

Japan, and the United States, along with the pharmaceutical trade associations from these three regions, to discuss scientific and technical aspects of product registration.

It is ICH’s mission to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration, thereby reducing duplication of testing and reporting carried out during the research and development of new medicines.

Conclusion

Benhur Pradeep

[email protected]

www.presentationpoint.com

Thank You


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Health & Medicine

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evolution of ich

formal ich procedure

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harmonization safety

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different types of ich