Why is transparency important to ICH?

ICH’s mission is to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for pharmaceutical product registration, thereby reducing or obviating duplication of testing carried out during the research and development of new human medicines.

Regulatory harmonisation offers many direct benefits to both regulatory authorities and the pharmaceutical industry with beneficial impact for the protection of public health. Key benefits include: preventing duplication of clinical trials in humans and minimising the use of animal testing without compromising safety and effectiveness; streamlining the regulatory assessment process for new drug applications; and reducing the development times and resources for drug development.

Bringing this vital message to interested stakeholders and the wider public in an accessible and understandable manner is important to ICH and serves as a mechanism to build trust. By making information publically available, the ICH Assembly and its Management Committee hope to make the ICH process ever more transparent, so that all stakeholders can be informed on important decisions and real-time progress of ICH Guideline development.

How has ICH approached the issue of transparency?

Increasing transparency about ICH was an issue that was taken up for discussion with the former Steering Committee of the ICH Parties in 2012. As a consequence, the first concrete action on expanding transparency was taken in June 2013.

At the request of the Steering Committee, the ICH Secretariat developed a proposal. This was then presented to the Steering Committee for endorsement and gave rise to a new list of documents that were previously not published but were then made available on the ICH website. The offering included publication of information about the ICH process on the ICH website, including publication of the concept paper, the business plan and the work plan before publishing the draft Guideline (endorsed at Step 2) for public consultation and at last the finalised Guideline (Step 4 adopted).

In 2005, the ICH Steering Committee agreed that following each of its meetings, a report should be published on the ICH website summarising the main decisions taken at each meeting. By making this information publicly available, the Steering Committee hoped to make the ICH process more transparent, so that all stakeholders would be up to speed about important decisions and real-time progress of ICH Guideline development.

Post 2012, ICH increased the consistency and speed of publishing information on its website, ensuring that it was up-to-date.

Why is ICH committing to further enhance transparency at this time?

There are two principle factors that have prompted ICH to re-examine its stance on transparency. The first is the obvious rise in public demand for more openness from companies, governments and institutions across the world. For the public and concerned bodies alike, transparency builds trust.

Secondly, recent reforms provide ICH with the chance to ensure that it is better-equipped to face the challenges of global pharmaceutical development and regulation. These reforms, which will transform ICH into a truly global initiative, also offer the opportunity to increase transparency and allow a wider audience to better understand and share in the success of the ICH initiative.

With this new approach to transparency, will ICH publish all documents?

ICH publishes the vast majority of its documents, either in full or in summary. Nevertheless there remain certain documents that ICH does not release due to reasons of confidentiality, or as a result of contractual obligations. One example is documentation related to the management of MedDRA.

How does ICH share its documents?

ICH has adopted a “one vehicle approach” to sharing documentation, ensuring that everything that ICH does publish is made available at a single port, namely the ICH website.

When are items and documents published?

In general, ICH aims to publish documents immediately after an event has taken place, although in specific instances this may not be possible. At ICH, certain documents must undergo review to assure clarity and accuracy before they may be released for publication to the website and this adds time to the transparency process. Due to the fact that ICH adopts a consensus approach to most of its activities, ICH Members may have the opportunity to amend or add information to documents. Once all Members are satisfied, the information can go forward for publication.

ICH does adopt a time frame for the publication of certain information, including agendas of ICH Assembly meetings. These are published in a consistent manner two weeks before a meeting takes place. The ICH Management Committee holds a teleconference prior to each ICH face-to-face meeting to agree on which working groups will be meeting. Immediately following the teleconference, ICH publishes a list of the working groups that are expected to meet, thus informing interested stakeholders and the public about which technical topics will be discussed during ICH week.

In exceptional cases concerning documents that contain sensitive or confidential information, the Chair of the Assembly, after consultation of the Management Committee or the MedDRA Management Committee, may decide that such documents are only provided to the Members.

Documents that are currently shared with ICH Stakeholders via the ICH website

ICH publishes a range of documents on its website, including:

  • ICH Articles of Association
  • ICH Assembly Rules of Procedure 
  • ICH Management Committee (MC) Rules of Procedure 
  • MedDRA Management Committee Rules of Procedure 
  • Standard Operating Procedures of ICH Working Groups 
  • ICH Membership application forms
  • Membership fees
  • Names and positions of Assembly, MC and MedDRA MC representatives 
  • Names and positions of ICH Coordinators 
  • Names and positions of experts on ongoing ICH Working Groups 
  • Assembly meeting agendas and reports 
  • MC meeting and teleconference reports 
  • ICH multi-annual strategic plan 
  • ICH annual work plan 
  • ICH budget 
  • ICH Association annual report 
  • MedDRA annual work plan
  • MedDRA budget
  • EWGs/IWGs work plans 
  • List of EWGs/IWGs scheduled to meet in ICH meetings 
  • ICH Guidelines 
  • Reflection papers, concept papers and business plans 
  • ICH and MedDRA press releases 
  • ICH training agendas, materials and strategy

Documents containing personal or confidential information are not routinely published, for example contracts and membership applications. In addition ICH does not publish documents, such as EWG/IWG drafts, that could prejudice the ICH consensus process ahead of formal public consultation.