ICH Guidelines for Pharmacovigilance | Organization and objectives of ICH | Pharmacovigilance Notes for BPharma 8 semester

Introduction:

• ICH is the “International Conference on Harmonization” of technical requirements for the registration of pharmaceuticals for human use.
• To assure safety, quality and efficacy of medicines, the members of ICH who include members from drug regulatory authorities and research based industries of
European Union, US and Japan will discuss on the technical procedures and documents required.

History
• In 1956 Thalidomide was approved for marketing in Europe and Africa for treating morning sickness in pregnant women.
• Lack of proper policies, Legislations and guidelines to ensure the safety, efficacy of the drug, 10,000 to 20,000 babies suffered from birth defects like phocomelia
• This disaster has initiated many policies, Legislations and amendments in acts to ensure the safety, efficacy, quality of the drugs, thus leading to the formation of International conference on harmonization in 1990

Need for Harmonization
• The difference in the technical requirements and the procedures followed by different countries made the global marketing of drugs as time consuming and expensive
• To reduce the cost and time required for the global marketing of drugs
• Harmonization of technical requirements has been promoted

• Special guidelines have been framed to ensure the quality, safety and the efficacy of the drugs

Objective of ICH
• To promote international harmonization of technical requirements to develop safe, effective, and high quality medicines.
• To reduce the registration cost.
• To promote public health
• To prevent the duplication of clinical trials in Humans
• To minimize the animal use without compromising on the safety and quality of drugs

Goal of ICH
• Promote international harmonization by bringing together representatives from the three ICH regions (EU, Japan and USA) to discuss and establish common guidelines
• Make information available on ICH, ICH activities and ICH guidelines to any country

Members of ICH
• ICH is comprised of representatives from six parties that represent the regulatory bodies and research based industry in the European Union, Japan and the USA
• In Japan, the members are the Ministry of Health, Labour and Welfare (MHLW), and the Japan Pharmaceutical Manufacturers Association (JPMA)
• In Europe, the members are the European Union (EU), and the European Federation of Pharmaceutical Industries and Associations (EFPIA).

• In the USA, the members are the Food and Drug Administration (FDA), and the Pharmaceutical Research and Manufacturers of America (PhRMA).
• Additional members include Observers from the World Health Organization (WHO), European Free Trade Association (EFTA), Canada

ICH steering committee
• Governs ICH
• Determines the policies and procedures for ICH
• Selects topics for harmonization
• Monitors the progress of harmonization initiatives

ICH coordinators
• The Coordinators are fundamental to the smooth running of the ICH and are nominated by each of the six parties of ICH. Coordinator acts as the main contact point with the ICH Secretariat.
• Operates from the IFPMA offices in Geneva, Switzerland

ICH coordinators (Responsibilities)
• Provides support to the ICH Steering Committee.
• Documents the meetings of the steering committee.
• Promotes coordination between Working Groups.
• Provides information on the ICH guidelines and ICH process.
• Provides administrative support for MedDRA management board.
• Provides administrative support for Global cooperation Group.

ICH global cooperation group
• Formed on March 11, 1999, as a subcommittee of ICH steering committee to Globalise the ICH and its guidelines
• One representative from each of the six parties of ICH steering committee
• ICH secretariat at IFPMA

ICH working groups
•Expert Working Group
•Implementation Working Group
•Informal Working Group
• Discussion group

ICH guidelines for pharmacovigilance
• This document gives standard definitions and terminology for key aspects of clinical safety reporting
• Gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development.
• The ICH has published a number of documents setting standards for safety, both clinical and pre-clinical.
• Pre-clinical guidelines have an “S” designation e.g. S1, S2 etc.
• The clinical safety guidelines are designated as “E”, standing for “Efficacy”

E – series
• E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions
• E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
• E2B (R2) Maintenance of the Clinical Safety Data Management including Data Elements for Transmission of Individual Case Safety Reports
• E2B (R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

• E2C (R1) Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs
• E2C (R2) Periodic Benefit-Risk Evaluation Report
• E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting
• E2E Pharmacovigilance Planning
• E2F Development Safety Update Report