International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of pharmaceutical product registration.

The purpose of ICH is to reduce or eliminate the need to duplicate the testing carried out during the research and development of new medicines by recommending ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration. Harmonisation would lead to a more economical use of human, non-human animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines while maintaining safeguards on quality, safety, and efficacy, and regulatory obligations to protect public health.

ICH guidelines have been adopted as law in several countries, but are only used as guidance for the U.S. Food and Drug Administration.^[1]

History

In the 1980s, what is today the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation; ICH was created in April 1990 at a meeting in Brussels.

In 2015, International Conference on Harmonisation changed its name to the International Council for Harmonisation while becoming a legal entity in Switzerland.^[2][3] On 23 October 2015 ICH conducted their initial meeting of their new assembly.^[3]

Structure

The ICH has four major parts:^[4]

1. ICH Steering Committee
2. ICH Coordinators
3. ICH Secretariat
4. ICH Working Groups

The Steering Committee, made of six ICH Parties, governs the ICH, determining the policies and procedures, selecting topics for harmonisation and monitoring progress of harmonisation initiatives. The ICH consists of:

• European Commission
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
• Ministry of Health, Labour and Welfare (Japan)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• Food and Drug Administration (FDA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)

The ICH Coordinators represents each ICH Party to the ICH Secretariat on a day-to-day basis.

The ICH Secretariat is primarily concerned with preparations for, and documentation of, meetings of the Steering Committee as well as coordination of preparations for Working Group (EWG, IWG, Informal WG) and Discussion Group meetings.

The ICH Working Groups are created by the Steering Committee when a new topic is accepted for harmonisation, and is charged with developing a harmonised guideline that meets the objectives outlined in the Concept Paper and Business Plan.

Face-to-face meetings of the EWG will normally only take place during the biannual SC meetings. Interim reports are made at each meeting of the SC.

If consensus is reached the EWG will sign the Step 2 Experts Signoff sheet and submit it to the SC to request adoption. If there is no agreement in the EWG within the time frame the SC may extend the time frame, suspend or abandon the harmonization project.

Step 2: Confirmation of EWG consensus by the SC

Step 2 is reached when the SC agrees, based on the report of the EWG, that there is sufficient scientific consensus on the technical issues for the draft guideline. This text is signed off by the SC as Step 2 Final Document.

Step 3: Regulatory consultation and discussion

The draft becomes subject of consultation in the three regions. It is published in the European Union (as draft CHMP or CVMP guideline), Japan (after translation by MHLW), and the USA (as draft guideline in the Federal Register) and everybody within these regions can comment on it. There is also an opportunity for companies, associations and authorities in non-ICH regions to comment on the draft, which is distributed by IFPMA and WHO. After obtaining all consultation results, the EWG will be resumed. A new rapporteur will be appointed from the regulatory party, preferably from the same region as the previous rapporteur. The same procedure described in Step 1 is used to address the consultation results into the Step 2 Final Document. The draft document to be generated as a result of the Step 3 phase is called Step 4 Experts Document.

If industry and regulatory EWG members agree on the alterations as a result of the consultation, the Step 4 Experts Document is signed by the EWG regulatory experts only (Step 4 Experts Signoff) and submitted to the SC to request adoption as Step 4 of the ICH process..

Step 4: Adoption of an ICH harmonised tripartite guideline

Step 4 is reached when the SC agrees that there is sufficient scientific consensus on the technical issues. If one industry party has strong objections to the adoption of the guideline due to deviations of the revised draft from the original consensus the regulatory parties may agree that a revised document should be submitted for further consultation. In this case, the EWG discussion may be resumed.

The Step 4 Final Document is signed off by the SC signatories for the regulatory parties of ICH as an ICH Harmonised Tripartite Guideline.

Step 5: Implementation

The ICH Harmonised Tripartite Guideline moves immediately to the final step of the process that is the regulatory implementation. This step is carried out according to the same national/regional procedures that apply to other regional regulatory guidelines and requirements, in the European Union, Japan, and the United States.

Information on the regulatory action taken and implementation dates are reported back to the SC and published by the ICH Secretariat on the ICH website.

See also

Notes

External links

• Official ICH website
• Analysis: New ICH M2 Requirements into eCTD NMV (=RPS)