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International Federation of Pharmaceutical Manufacturers & Associations



© ICH

  • Regulatory harmonisation offers many benefits to both regulatory authorities and the pharmaceutical industry, and has a positive impact for the protection of public health.
  • Through the development of harmonised guidelines ICH works to: streamline the regulatory assessment process for new drug applications; reduce the development times and resources needed for drug development; prevent duplication of clinical trials in humans; and minimise the use of animal testing without compromising safety and effectiveness.
  • ICH’s work to harmonise requirements in the drug registration process promotes quicker access to medicines for patients.
  • ICH has evolved since its inception to respond to the increasingly global face of drug development, and through its ICH Global Cooperation Group works so that the benefits of international harmonisation for better global health can be realised worldwide.

Background

ICH was created in 1990, driven by a growing divergence in laws, regulations and guidelines between the ICH regions related to the reporting and evaluation of the data on safety, quality and efficacy of new medicinal products. For industry, this divergence made it necessary to duplicate many time-consuming and expensive test procedures, in order to market new products internationally, and as a consequence had a negative impact on the timely access to these medicines for patients.

ICH counts in the membership of its Steering Committee (SC) six co-sponsors (EU, EFPIA, MHLW, JPMA, FDA & PhRMA) and includes as Observers the World Health Organization (WHO), Health Canada and the European Free Trade Association (EFTA). The IFPMA, which has been closely involved with ICH since its inception, hosts the ICH Secretariat and participates as a non-voting member of the SC.

To-date, more than 50 harmonised guidelines and standards have been developed through a process of scientific consensus with regulatory and industry experts working side-by-side. The outputs of the ICH process cover a range of safety, quality and efficacy topics, but also involve a number of important multidisciplinary topics, which include the CTD (Common Technical Document) and MedDRA (Medical Dictionary for Regulatory Activities).

Whilst ICH technical working groups see participation from regulatory and industry experts of the six ICH Parties, many groups also see the participation of WHO, Health Canada and EFTA experts, in addition to regulatory experts from beyond the ICH regions and industry experts from the biotech, generic and over-the-counter medicine sectors.

Key to the success of the ICH process is the commitment of the ICH regulators to implement the final Guidelines. As ICH enters its third decade of activity its attention is directed towards extending the benefits of harmonisation beyond the ICH regions. The ICH Global Cooperation Group plays a key role in this effort, counting in its membership representatives from regulatory authorities and other harmonisation initiatives from across the globe. Training, as well as active participation of non-ICH regions in guideline development are seen as key to extending the benefits of ICH worldwide, with implementation of ICH agreed standards across all regions.

ICH, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

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