ICH Meeting in Lisbon, Portugal, 11 to 16 June 2016


The International Council for Harmonisation (ICH) met in Lisbon, Portugal from 11 to 16 June 2016.

In accordance with the objective of establishing ICH as a global platform for harmonising technical requirements pertaining to the development and authorisation of medicinal products, the Assembly officially welcomed two new members and a total of 14 observers.

Benefit/risk assessment, global drug development and other highlights

The updated guideline developed by the M4E(R2) Expert Working Group on the subject of “Enhancing the Format and Structure of Benefit-Risk Information” was approved by the Assembly in Step 4.

When guidelines are adopted by consensus within the ICH organisation (Step 4), they are regarded as harmonised and therefore as documents that reflect the current state of science and technology (cf. Swissmedic Journal 05/2006, p. 504).
Swissmedic will apply the revised guideline accordingly when it is published on the ICH website.

The E17 Expert Working Group on “Multi-regional clinical trials” has made significant progress in its work. The draft version of the guideline was approved and will now be published for external consultation. The final guideline is scheduled for adoption in 2017.

The E6(R2) Working Group on the “Integrated Addendum: Good Clinical Practice” met in Lisbon and reached Step 3 of the ICH process. It is scheduled to reach Step 4 by the end of 2016.

New topics for international harmonisation
The Assembly endorsed two new topics for harmonisation.
The first guideline to be newly developed will address the subject of the “Biopharmaceutical classification system-based biowaivers”. The aim of the future ICH M9 Expert Working Group will be to achieve global harmonisation on the applicability of biowaivers and the corresponding data required.

As a second new topic, ICH will tackle “Bioanalytical method validation”, for which regulatory requirements have already been introduced in the EU, the USA and Japan. The future ICH M10 guideline will address existing discrepancies between individual specifications and point out a harmonised approach.
The next ICH meetings will be held in Osaka, Japan, from 5 to 10 November 2016, and in Montreal, Canada, in spring/summer 2017.

The full ICH press release can be found at:


Swissmedic, Swiss Agency for Therapeutic Products
Cordula Landgraf
Head of Networking

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