NAVIGATION
In the interest of promoting public health and safety, one of the U. S. Federal Drug Administration’s (FDA) continual goals is to foster the advancement of the global harmonisation of regulatory requirements and practices. The relationship between the FDA and the ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use), is an important component of this initiative.
ICH Defined
The ICH is a joint initiative between industry manufacturers and government regulators whose purpose is to standardize the interpretation and application of technical guidelines.
A group such as ICH was needed as a result of the increase in regulations worldwide. While basic principals remained the same, different technical requirements by regulatory agencies were adding inefficiencies to the global industry. In addition, creation of the ICH would increase efficiency by decreasing global duplication of time consuming and expensive regulatory activities.
The harmonisation efforts greatly improve all regulations as a result of collaboration. The cooperation among intelligent minds from quality concerned countries provides a more efficient and effective way to protect public health.
Who Is the ICH?
The European Community (EC) initially attempted to create this collaborative group in the 1980s, commencing discussions with Japan and the United States. More specific plans occurred at a World Health Organization (WHO) conference in 1989. The ICH was officially established in 1990 by the EC. Representatives from Europe, Japan, and United States were present at the first meeting. Today the following countries and parties are involved:
- United States – FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
- Europe – European Commission, European Federation of Pharmaceutical Industries Associations
- Japan – Japanese Ministry of Health, Labor and Welfare and the Japanese Pharmaceutical Manufacturers Association
- ICH Secretariat (which coordinates the preparation of documentation) – International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
- ICH Steering Committee – includes representatives from each of the ICH sponsors and Health Canada, the European Free Trade Area (EFTA) and the World Health Organization
The name ICH (International Conference on Harmonisation) was derived from the goal of hosting a Harmonisation Conference. Six conferences were held until 2003 when it was decided that smaller, more focused public ICH meetings would be held.
What Does ICH Do?
The goal of ICH is to “achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.”
At one of the first meetings after initialization, it was decided that there would be three main categories of focus:
- Safety
- Quality
- Efficacy
Since that time, much has been accomplished. The ICH has harmonized the regulatory requirements for the testing, application, and approval process of pharmaceutical medicines and medical devices. Over 80 documents are listed on the ICH website including guidelines and standards, including two useful documents:
- MedDRA (Medical Dictionary for Regulatory Activities) – contains highly specific standardized medical terminology
- CTD (Common Technical Document) – describes the common format for the preparation of a well-structured application that will be submitted to regulatory authorities.
The FDA references the guidelines prepared via the ICH collaboration on their website. Some of the guidance documents listed include, but are not limited to:
- E6 Good Clinical Practice: Consolidated Guideline
- Annex 8 Sterility Test General Chapter
- Q7 A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
- Q8 Pharmaceutical Development
- Q9 Quality Risk Management
- Q10 Pharmaceutical Quality System
The ICH process has achieved significant harmonisation of the technical requirements for the approval of pharmaceuticals for human use in the three ICH regions (EC, U.S., Japan).
While ICH has previously focused on implementing the ICH Guidelines in ICH’s own regions, their currentfocus is to extend the benefits of the collaboration beyond the current ICH regions.
Benefits to Industry
The collaboration between FDA and ICH offers many direct benefits to our industry in time, effort, and cost, including, but not limited to, the following:
- Globally unifying testing strategies (for applications and other regulatory/compliance needs) (e.g., one test can be conducted rather than three)
- Reducing or eliminating the need to go through a justification procedure (e.g., the process can be completed one time and will eliminate repetitive justifications) by regulators
- Increasing efficiency in developing and registering new products in other countries
- Sharing knowledge globally
- Creating resources that, if utilized, will facilitate safer products from supplier through finished product
- Eliminating duplication in development and registration process
- Streamlining regulatory assessment process for new drug applications
- Reducing the development times and resources for drug development
The FDA made the following statements regarding its involvement with the ICH:
- “ICH was established in 1990 as a joint regulatory/industry project to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness.”
- FDA “is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development.”
- FDA has participated in many meetings designed to enhance harmonisation and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonisation “is to identify and then reduce differences in technical requirements for medical product development among regulatory agencies.”
Industry Tools from ICH:
There are a variety of tools available through the ICH, which can be utilized by the industry:
Use of CTD – aid in preparing proper format for applications to be submitted
- ESTRI (Electronic Standards for the Transfer of Regulatory Information) – when complete, this will facilitate international electronic communication; a product of this has been eCTD (Electronic Common Technical Document) which allows for the electronic submission of the CTD
- MedDRA – Medical Dictionary for Regulatory Activities Terminology – for all phases of product development; this is available on subscription.
- Free Guidelines to every country, as long as ICH is cited
- One can register for an RSS feed on the ICH website to receive a notice every time a new Guideline is added or modified on the website.
The U.S. FDA’s critical involvement in the co-foundation of the ICH has resulted in a globally harmonized industry community. Shared knowledge is powerful, and the joint venture that has occurred between FDA and ICH has proven to be productive and beneficial to the global body of knowledge, assisting in the quality and compliance of our industry.
Happy New Year!
© Coda Corp USA 2010. All rights reserved.
References:
http://www.ich.org/home.html
http://www.fda.gov/RegulatoryInformation/Guidances/ucm122049.htm
http://www.fda.gov/InternationalPrograms/HarmonisationInitiatives/ucm114571.htm
http://edocket.access.gpo.gov/2010/2010-23642.htm – [Federal Register: September 22, 2010 (Volume 75, Number 183)][Notices][Page 57803-57804]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr22se10-92]
http://edocket.access.gpo.gov/2010/2010-23642.htm – [Federal Register: September 22, 2010 (Volume 75, Number 183)][Notices][Page 57803-57804]From the Federal Register Online via GPO Access [wais.access.gpo.gov][DOCID:fr22se10-92]
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM229751.pdf
