Table of Contents
What is the ICH Steering Committee?
The Steering Committee, which previously only included members from the US, EU and Japan, is highly influential in all ICH activities. Per the ICH Proceduresdocument, the committee must endorse all proposed regulations. Any one member of the committee can derail a proposed regulation.
Who are the members of ICH?
Regulatory Members
- ANVISA, Brazil.
- COFEPRIS, Mexico.
- HSA, Singapore.
- MFDS, Republic of Korea.
- MHRA, UK.
- NMPA, China.
- SFDA, Saudi Arabia.
- TFDA, Chinese Taipei.
What is the purpose of ICH?
ICH aims to achieve greater harmonisation worldwide for the development and approval of safe, effective, and high-quality medicines in the most resource-efficient manner.
What does ICH stand for?
International Conference on Harmonization
This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
What are the benefits of ICH?
Key benefits include: preventing duplication of clinical trials in humans and minimising the use of animal testing without compromising safety and effectiveness; streamlining the regulatory assessment process for new drug applications; and reducing the development times and resources for drug development.
How many countries are part of ICH?
ICH is now constituted by 16 Members and 28 Observers, after the ICH Assembly in 2018 approved TFDA, Chinese Taipei as a new Regulatory Member, and MMDA, Moldova, NPRA, Malaysia, NRA, Iran, SCDMTE, Armenia and TİTCK, Turkey as new Observers.
Who founded ICH?
The birth of ICH took place at a meeting in April 1990, hosted by EFPIA in Brussels. Representatives of the regulatory agencies and industry associations of Europe, Japan and the US met, primarily, to plan an International Conference but the meeting also discussed the wider implications and terms of reference of ICH.
WHO founded ICH?
What are the four working groups within ICH?
The ICH Guidelines are divided into four major categories and ICH Topic Codes are assigned according to these categories.
- “Quality” Topics.
- “Safety” Topics.
- “Efficacy” Topics.
- “Multidisciplinary” Topics.
What are the three ICH regions?
ICH was established through cooperation of the regulatory agencies and industrial parties of three main regions involved in pharmaceuticals: the European Union, the United States, and Japan.
What is the history of ICH?
WHO established ICH?
Who established ICH?
When did ICH start?
Thus, the ICH was born in 1990 out of necessity for more standardized, or harmonized, regulatory requirements between countries.
What does the ICH Steering Committee do?
The ICH Steering Committee Governs the ICH Determines ICH policies and procedures Decides on the adoption of ICH projects • Selects topics for harmonisation • Endorses the creation of ICH Working Groups Monitors and facilitates the progress of ICH Working Groups Signs off ICH documents 5 6 6 Steps of ICH Harmonization
How will the new structure of Ich be funded?
in future ICH meetings with an expectation of continuity and stable participation The funding of ICH operations (secretariat, meetings etc.) will initially be ensured by the Permanent Members of the Management Committee. This ensures continuation of ICH operations and contributes to a smooth transition to the new structure. In the
How many scientific guidelines have been produced on Ich?
• 70+ scientific guidelines produced (1990 – 2013) • PhRMA member company scientific and regulatory leaders agree that ICH provides value – More than three-fourths believe existing ICH guidelines address