ICH Assembly in Osaka, Japan, 5 to 10 November 2016


The International Council for Harmonisation (ICH) met in Osaka, Japan from 5 to 10 November 2016.

In line 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 welcomed the Brazilian authority Agência Nacional de Vigilância Sanitária (ANVISA) and the Korean Ministry of Food and Drug Safety (MFDS) as the first two new regulatory members. The Biotechnology Innovation Organization (BIO) was greeted as a new industry association member.

As a result, the ICH Assembly now has 13 members and 22 observers. For further details, visit the ICH website

Amendment to the global Guideline on Good Clinical Practice (GCP) adopted.
The 1996 ICH Guideline on GCP is one of the most important achievements of the ICH process. The ICH Assembly adopted an important amendment – ICH E6(R2) – that aims to encourage sponsors to implement improved oversight and management of clinical trials.

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 (see Swissmedic Journal 05/2006, p. 504).

To implement ICH E6(R2) in Switzerland, the Federal Department of Home Affairs will have to amend the reference to the Human Research Act in Annex 1 of the Clinical Trials Ordinance (ClinO). This amendment should have been made in the second quarter of 2017. Since Version R2 essentially synthesises existing requirements from other guidelines, Swissmedic will use it as a reference with immediate effect.

Furthermore, the Assembly agreed to renew the wider package of guidelines relating to GCP and clinical trial design.
A reflection paper that includes an outline of longer-term work planning, starting with the revision of the ICH E8 guideline, is expected to be published in early 2017.

Optimising safety data collection
Recognising the increased interest in collecting data on the long-term effects of medicinal products, the Assembly also decided to develop a new guideline intended to optimise safety data collection.

The new guideline (ICH E19) aims to harmonise requirements on the optimal collection of safety data during late-stage pre-market and post-approval clinical investigations. This will help improve global health by encouraging studies of the long-term effects of medicinal products, rare events and new indications by reducing the resources required for these studies.

ICH members will also seek to work closely with stakeholders, especially patient representatives, in the development of the guideline.

Other decisions
Individual Case Safety Reports (ICSRs) play an important role in supporting drug safety surveillance around the world. The Assembly agreed to an update of the implementation guide for ICH Guideline E2B(R3) and to a Question & Answer document. Both of these documents will be published on the ICH website.

Using the guideline “Development and Manufacture of Drug Substances” (ICH Q11) adopted in 2012 as a basis, a Question & Answer document has been developed to clarify a number of issues that have arisen. The draft document will now be released for stakeholder consultation.
The next ICH meeting will be held in Montreal, Canada, from 27 May to 1 June.

The full ICH press release can be found at:


Swissmedic, Swiss Agency for Therapeutic Products
Cordula Landgraf
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