International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) – Introduction

ICH:

The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was launched in April 1990 at a meeting in Brussels.

Members:

Europe, Japan, USA, Australia and Canada

Purpose:

  • It brings together the regulatory authorities and experts from the pharmaceutical industry to discuss scientific and technical aspects of pharmaceutical product registration.
  • To reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonization in the interpretation and application of technical guidelines and requirements for product registration.

Mission:

ICH’s mission is to achieve greater harmonization to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

Constitution:

 The ICH consists of:

  • European Commission (EC)
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • Ministry of Health, Labour and Welfare  (Japan)
  • Japan Pharmaceutical Manufacturers Association (JPMA)
  • Food and Drug Administration (FDA)
  • Pharmaceutical Research and Manufacturers of America (PhRMA)

ICH guidelines:

  • Q – Quality [Q1-Q14]
  • S – Safety [S1-S12]
  • E – Efficacy [E1-E20]
  • M – Multidisciplinary [M1-M13]

COMMON TECHNICAL DOCUMENT (CTD)

The Common Technical Document (CTD) is a set of specification for application dossier, for the registration of Medicines and designed to be used and agreed “well structured common format” for the orgnisation of technical requirements to be submitted to regulatory authorities across Europe, Japan and the United States.

CTD format for submission of drug registration applications/dossiers is widely accepted by regulatory authorities of other countries too like Canada, Australia etc.

TIMELINE OF CTD:

1995: Concept of CTD proposed.

NOV 2000: ICH guidelines finalized.

SEP 2002: Guidelines edited with No. & Header

2003: CTD mandatory

2008: eCTD CDER standard

2009: CDSCO adopted CTD format

Organization of CTD:

CTD is divided into 5 modules

Module 1 – Administrative information and prescribing information (Regional)

Module 2 – Common Technical Document summaries (Overview & summary of modules 3 to 5)

Module 3 – Quality 

Module 4 – Nonclinical Study Reports (toxicology studies)

Module 5 – Clinical Study Reports (clinical studies)

Related Articles

Important and Useful FDA links

Home http://www.fda.gov/ CFR http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm Orange book http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm REMS http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm BMIS http://www.accessdata.fda.gov/scripts/cder/bmis/index.cfm Clinical Investigator Search http://www.accessdata.fda.gov/scripts/cder/cliil/index.cfm Dissolution Database http://www.accessdata.fda.gov/scripts/cder/dissolution/index.cfm Drug Establishment Registration http://www.accessdata.fda.gov/scripts/cder/drls/default.cfm Drug Shortages http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm…

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