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# ICH Adds New Global Drug Development Partners
- URL: https://www.fdaweb.com/ich-adds-new-global-drug-development-partners/
- Published: 2016-07-01T12:00:00.000Z
- Updated: 2026-09-14T21:12:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136111

The International Council for Harmonization (ICH)[says ](http://www.ich.org/ichnews/newsroom/read/article/press-release-ich-assembly-meeting-in-jacksonville-fl-usa-december-2015-copy-1.html?ref=fdaweb.com)it increased its “global reach,” by formally adding last month two new members and 14 observers. ICH welcomed the following as new observers:

- · Association of Southeast Asian Nations
- · Biotechnology Innovation Organisation
- · Central Drugs Standard Control Organization
- · Council for International Organizations of Medical Sciences
- · Comisión Federal para la Protección contra Riesgos Sanitarios (Mexico)
- · East African Community
- · European Directorate for the Quality of Medicines & HealthCare
- · Health Sciences Authority
- · International Pharmaceutical Excipient Council
- · Ministry of Food and Drug Safety
- · Roszdravnadzor
- · Food and Drug Administration
- · Therapeutic Goods Administration
- · United States Pharmacopeia

In addition, two new pharmaceutical industry bodies were welcomed — International Generics and Biosimilars Association and World Self-Medication Industry accepted as members.

At the same meeting that voted the new member additions, ICH voted to adopt a final revised ICH guideline on format and structure of benefit-risk information in the common technical document (ICH M4E (R2)). “Given the importance of benefit-risk assessment for drug regulation, this is expected to support regulatory decision-making through a more consistent description of information coming from clinical trial data, as well as other factors such as disease severity and availability of other treatment options,” the group said. “Recognizing the increasing role of the patient voice in drug development and regulation, the revised guideline also opens the possibility to include information about patient perspectives, for example information from patient preference studies. This revised guideline will now be implemented by each of the ICH regulatory members.”

Another highlight was a vote of support on a draft guideline on multi-regional clinical trials (ICH E17). With the move to global drug development, the guideline is “intended to support the planning and design of multi-regional clinical trials, a reduction in unnecessary duplication of studies and the subsequent acceptability to regulators of data from those trials,” ICH says. The draft guideline will now be released for stakeholder comments, with adoption of the final guideline expected next year.