Merriam-Webster dictionary defines the word Harmony as "to bring into consonance or accord". Harmonisation helps different departments in local authorities share the same vision, work together and optimize the use of resources. The concept of harmonisation is highly essential in the pharmaceutical industry to ensure safe and effective development, manufacture, storage, and registration of drugs whilst meeting high standards.
In this article, I help you understand the need for and the role played by the International Council for Harmonisation in the Pharmaceutical industry.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss scientific and technical aspects of drug registration. It works side-by-side with the regulators and the pharmaceutical industries to develop guidelines for the safe and effective manufacture of drugs. ICH's mission is to ensure harmonisation worldwide by publishing guidelines which is successfully implemented by the regulators.
ICH's mission statements as stated on its website are below:
To make recommendations towards achieving greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations;
To maintain a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonisation of the technical requirements for pharmaceutical products;
To contribute to the protection of public health in the interest of patients from an international perspective;
To monitor and update harmonised technical requirements leading to a greater mutual acceptance of research and development data;
To avoid divergent future requirements through harmonisation of selected topics needed as a result of therapeutic advances and the development of new technologies for the production of medicinal products;
To facilitate the adoption of new or improved technical research and development approaches that update or replace current practices;
To encourage the adequate implementation and integration of common standards through the dissemination of, the communication of information about and coordination of training on, harmonised guidelines and their use;
And to develop a policy for the ICH Medical Dictionary for Regulatory Activities Terminology (MedDRA) whilst ensuring the scientific and technical maintenance, development, and dissemination of MedDRA as a standardized dictionary that facilitates the sharing of regulatory information internationally for medicinal products used by humans.
The responsibility of the Auditors is to audit the financial statements of the Association upon conclusion of each Fiscal Year. They should ensure that the accounting of the Association complies with Swiss law and generally accepted Swiss accounting principles.
The ICH Assembly brings together all Members and Observers of the ICH Association as the overarching governing body of ICH.
The ICH Assembly Chair is Ms. Lenita Lindström-Gommers (EC, Europe) and the ICH Assembly Vice-Chair is Dr. Celia Lourenco (Health Canada, Canada).
The ICH Management Committee (MC) is the body that oversees operational aspects of ICH on behalf of all Members, including administrative and financial matters and oversight of the Working Groups (WGs). The MC is responsible for submitting recommendations or proposals to the Assembly in preparation of Assembly discussions.
MedDRA Management Committee
The MedDRA Management Committee (MC) has responsibility for direction of MedDRA, an ICH standardised dictionary of medical terminology. The MedDRA MC is composed of the EC, Europe; EFPIA; MHLW/PMDA, Japan; JPMA; FDA, United States; PhRMA; MHRA UK; Health Canada, Canada; and WHO (as Observer).
Located in Geneva, Switzerland, the ICH secretariat is is responsible for day-to-day management of ICH, coordinating ICH activities as well as providing support to the Assembly, the ICH Management Committee and its Working Groups.
Coordinators ensure proper distribution of ICH documents to the appropriate persons from their organisation and are responsible for the follow up on actions within their respective organisation within assigned deadlines.
It covers the topics in the areas of QSEM - Quality, Safety, Efficacy, and Multidisciplinary Guidelines.
Quality - Quality in the stability studies, Good Manufacturing Practices, etc., (Q1 through Q14 with around 57 guidelines).
Safety - Toxicity, carcinogenicity, and QT interval prolongation studies. (S1A through S12 with around 21 guidelines).
Efficacy - Design, conduct, safety, and reporting of clinical trials. (E1 through E20 with around 37 guidelines).
Multidisciplinary Guidelines - MedDRA, CTD, Electronic Standards for the Transfer of Regulatory Information (ESTRI). (M1 through M13 with around 19 guidelines)
The schedule of the ICH Focussed Public events can be viewed here.
ICH.org also conducts several training programs in its effort to achieve global harmonised implementation of ICH Guidelines.
Stay tuned for more in-depth posts about each of the ICH Guidelines!
Follow my blog posts closely as I will be posting content related to the A00-280: Clinical Trials Programming Using SAS 9 certification. All these posts will come in handy for anyone preparing for this certification exam.
1. What is the main focus of Good Clinical Practices (GCP)?
a) harmonized data collection
b) standard analysis practices
c) protection of subjects
d) standard monitoring practices
2. In the ICH E10 guideline, the definition "A measurable DNA and/or RNA characteristic that is an indicator of normal biologic processes, pathogenic processes, and/or response to therapeutic or other interventions. " describes:
a) Genetic Biomarkers
d) Genomic Data
More questions will be updated as and when it is available. Monitor this section closely.
3. Khagga, Bhavyasri, Kaitha Manisha Vishnumurthy, Dammu Rambabu and Mogili Sumakanth. ICH guidelines – “Q” series (quality guidelines) - A review, GSC Biological and Pharmaceutical Sciences e-ISSN: 2581-3250, CODEN (USA): GBPSC2.