This blog features:
- Definitions of ICH guidelines
- Components of ICH guidelines
- What are abbreviations of ICH terms determine?
Table of Contents:
- Introduction
- What and Who is ICH?
- Purpose
- Founding members of ICH
- Responsibilities
- Guidelines
- Key Takeaways
- Conclusion
Introduction
This authority speaking specific blog where we explore about the organisation that is ICH. We will explore some facts about ICH the organisation comprises for better human health.
What and Who is ICH?
ICH (International Conference of Harmonisation) is an organisation, it is registration aunthority of pharmaceutical products for Hunam use. It is an initiavtie by regulators and research-based pharmaceutiacl organisations.
Purpose
The aim of establishment of ICH is to standardise and streamline the scientific and technical aspects of the drug regulatory process.
Its purpose is to achieve greater harmonisation of technical guidelines and requirements for pharmaceutical product registration.
“Guidelines are essential for ensuring the proper flow and correcting deviations, guiding individuals along the correct path forward.”
Founding Members of ICH
- In Europe: European union and European Federation of Pharmaceutical Industries and Associations (EFPIA).
- In USA: Food and Drug Administration (FDA) and Pharmaceutical Research and Manufacturers of America (PhRMA).
- In Japan: Ministry of Health, Labour and Welfare (MHLW) and the Japan Pharmaceutical Manufacturers Association (JPMA).
- Observers from European Free Trade Association (EFTA), Health Canada, and the World Health Organization (WHO).
Responsibilities
- ICH facilitates the interchange of electronic documents and records.
- MedDRA and the ICSR expedite the exchange of information, enhancing the efficiency of sharing critical regulatory data.
Overview of ICH with E2B
The initial endorsement of the ICH E2B guideline occurred on July 17, 1997, with subsequent modifications in November 2000. The revised version was then published in 2001, incorporating minor adjustments.
ICH Guidelines
ICH addresses and develops numerous guidelines categorized into three primary areas:
- Quality (Q)
- Safety (S)
- Efficacy (E)
- Additionally, Multidisciplinary standards (M) are also covered.
1. Quality
Under the quality category, guidelines marked with “Q” (14 in total) focus on setting standards within the pharmaceutical industry. They cover aspects like stability, impurity testing, and Good Manufacturing Practices (GMP).
2. Safety
Safety guidelines, beginning with “S“, consist of 12 comprehensive standards aimed at identifying potential risks such as carcinogenicity, genotoxicity, and reproductive toxicity. These guidelines detail how to conduct tests with safety precautions in mind.
3. Efficacy
Efficacy guidelines fall under the “E” category, exclusively addressing the design, implementation, safety, and reporting of clinical trials to develop more targeted medicines. There are 22 main guidelines in this category, with several sub-guidelines derived from them. For instance, E2 encompasses 10 sub-guidelines.
4. Multidisciplinary Guidelines
These guidelines cover topics that span across various categories, not fitting neatly into the aforementioned groups.
They include descriptions of MedDRA terminology, the Common Technical Document (CTD), and the development of Electronic Standards for the Transfer of Regulatory Information (ESTRI). There are a total of 15 guidelines under this category, all starting with the letter “M“.
Key takeaways
- It’s incorrect to claim that ICH is a non-profit organization.
- ICH guidelines are established to harmonize practices for the betterment of human health.
- There are four main categories of guidelines: Q, S, E, M: Q for Quality, S for Safety, E for Efficacy, and M for Multidisciplinary.
- The “M” category serves as a collective pool for topics common across different areas, unlike the other categories that focus on specific aspects.
- The primary founding members of ICH are from Europe, the USA, and Japan.
Conclusion
In our preceding discussion, we’ve delved into various aspects of ICH, its guidelines, and their purpose. While this brief exploration may have unveiled on certain facets and provided clarity.
It’s possible that we’ve overlooked some elements or made errors. We welcome any corrections or recommendations you may have regarding pharmacovigilance.
For further information about ICH, its EWGs and standards, and supporting documentation is available from the ICH website.
Your input is valuable as we strive to enhance our understanding and knowledge in this field.
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