SIGNIFICANT PROGRESS ON ICH COMMON TECHNICAL DOCUMENT

Tokyo, August 31 - September 3, 1998

At its meeting in Tokyo, 31 August - 3 September 1998 the ICH Steering Committee welcomed reports of significant progress from its Expert Working Groups on the ICH Common Technical Document for the registration of new medicines. Working in parallel, three groups addressed the format and content of the quality, safety and efficacy sections of an international registration dossier. Regulatory specialists reported that they are nearing consensus on the harmonisation of the table of contents as well as the content of clinical and non-clinical summaries and tabulations. The project is well on target with a finalised document expected by the year 2000.

Encouraged by this success the Steering Committee agreed that work should commence on adapting the Common Technical Document into an electronic version. This could change significantly the way in which regulatory information is provided in the future, facilitating better and more economical management of documentation.

The Steering Committee also confirmed that a Fifth International Conference on Harmonisation would take place in the USA in the last quarter of 2000 and a location on the West Coast is being sought. The main focus for ICH 5 will be reporting agreements on completion of the ICH Common Technical Document (CTD).

Although the CTD is the primary project for ICH Phase II the Steering Committee received reports on another important effort; GMP requirements for active pharmaceutical ingredients. An extended Expert Work Group moved closer to its goals aided by experts from outside the three ICH regions. The group is close to consensus on a consistent approach of ensuring the quality of active ingredients used in medicines world-wide.

Recognising that initiatives are well underway in all three regions to promote the early availability of important new medicines for children the Steering Committee formally adopted a new topic on clinical trials involving children. Other new topics considered for adoption in the near future include safety pharmacology and a pilot project is proposed to harmonise the approaches to clinical trials in specific therapeutic areas.

Another significant Phase II activity is the maintenance and updating of previous ICH agreements. A major review of one of the earliest ICH Guidelines - Stability Testing - was initiated. In addition several minor clarifications and updates of other guidelines will be undertaken including those on residual solvent impurities and on the format and content of individual adverse event reports.

At the same time completion of Phase I activities drew a Step closer. The Steering Committee confirmed the consensus, reached at the time of ICH 4 on repeat-dose toxicity testing requirements in animals (S4). The publication of this finalised guideline will mark a further step towards the ICH objectives of eliminating redundancy in the testing process for new drugs.

Progress on a guideline for the choice of control groups in clinical trials (E10) is nearing consensus and will complete efficacy topics from Phase I.

Another ICH activity of a somewhat different nature, the establishment of a new medical terminology (MedDRA) to be used in a wide range of regulatory activities but particularly in the reporting of adverse drug reactions, is moving towards completion The Steering Committee is in process of selecting a Maintenance and Support Services Organisation (MSSO) to license, maintain and distribute the terminology under contract. The Steering Committee has appointed the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) as trustee of the rights to the terminology in order to establish a contract with the MSSO.