The FDA has a strong interest in promoting the health and safety of U.S. citizens; in addition, it also supports the advancement of the global harmonization of regulatory requirements and practices. To accomplish this goal, the FDA has partnered with regulatory bodies of several other countries to form the International Conference for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The ICH is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990 by the U.S., the European Union, and Japan, the ICH has evolved to respond to the increasingly global face of drug development.
At the first Steering Committee meeting of the ICH, the Terms of Reference were agreed upon, and it was decided that the topics selected for harmonization would be divided into Safety (14 guidelines), Quality (23 guidelines), and Efficacy (21 guidelines) to reflect the three criteria which are the basis for approving and authorizing new medicinal products. The ICH has also issued six multidisciplinary guidelines.
The Need for the ICH
In various countries around the world, there was a rapid increase in laws, regulations, and guidelines for reporting and evaluating the data on safety, quality, and efficacy of new medicinal products in the 1960s and 1970s. This was also a time when drug manufacturers were seeking to market their products internationally. Unfortunately, there was a wide divergence in technical requirements from country to country, requiring manufacturers to duplicate many time-consuming and expensive tests in order to market their products internationally.
The international need to harmonize regulations quickly became obvious and was accelerated by concerns over rising costs of healthcare, escalation of the cost of R&D, and the need to reduce the delay in making safe and efficacious new drug products available to patients in need.
The Purpose of the ICH
ICH's mission is to achieve greater harmonization worldwide to ensure that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. The organization seeks to make recommendations towards achieving greater harmonization in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration and the maintenance of such registrations. They do this by maintaining a forum for a constructive dialogue on scientific issues between regulatory authorities and the pharmaceutical industry on the harmonization of the technical requirements for pharmaceutical products.
Harmonization is achieved through the development of ICH Guidelines using a process of scientific consensus with regulatory and industry experts working side-by-side. There are several keys to the success of the ICH, including:
- Expertise from both regulatory authorities and the industry
- Guidelines are science-based, consensus driven
- Following a clear and effectively managed process
- Close collaboration of parties with comparable regulatory and technical capability
- Regulators are committed implementing the ICH’s guidelines
- There are common global platforms and tools
- The ICH remains current by revising its processes and governance
ICH Membership
Initially, seeking to create a collaborative group, the European Commission reached out to the U.S. and Japan. Specific plans for an organization were decided upon at a World Health Organization (WHO) conference in 1989, and the ICH was officially established in 1990 by representatives of the US, the EU, and Japan.
Today, the following countries and entities are involved with the ICH:
- United States – the FDA, the Pharmaceutical Research and Manufacturers of America (PhRMA), the Center for Drug Evaluation and Research (CDER), and the Center for Biologics Evaluation and Research (CBER)
- Europe – European Commission and the European Federation of Pharmaceutical Industries Associations
- Japan – Japanese Ministry of Health, Labour 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, as well as Health Canada, the European Free Trade Area (EFTA), and the WHO
What does compliance look like?
U.S. drug manufacturers must be aware of both FDA and ICH guidance when seeking to market drug products either just in the U.S. or in multiple international markets. Think of an ICH guidance as the lowest common denominator regarding safety, quality, and efficacy. While an ICH partner country might have higher standards in some areas or desire to raise issues that the ICH guidance does not address, manufacturers have a standard benchmark in the ICH guidance.
Are you in the process of developing a product that you plan to market in the US and/or internationally? Ensuring compliance with all FDA and ICH regulations and requirements can get tricky and confusing, but we are here to help. Our experts can help guarantee that your product is compliant and that it remains that way. To learn more about our services and how we can help you ensure compliance, contact us today.
