|International Conference on Harmonisation
|MedDRA MSSO Appointed, November 1998|
|ICH Steering Committee Meeting, September 1998|
|ICH Steering Committee Meeting, February 1998|
MedDRA MAINTENANCE AND SUPPORT SERVICES ORGANIZATION (MSSO) SELECTED
BDM International, Inc., a wholly-owned subsidiary of TRW, Inc., has been selected as the Maintenance and Support Services Organization (MSSO) for the ICH Medical Dictionary for Regulatory Activities (MedDRA) Terminology.
MedDRA, the new international medical terminology, developed by the International Conference on Harmonisation (ICH), is designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. It will be particularly important in the electronic transmission of adverse event reporting, both in the pre- and post-marketing areas, as well as the coding of clinical trial data.
IFPMA acting as the Trustee of the ICH Steering Committee for the ownership of MedDRA hosted a meeting in Geneva, 24 November 1998, at which the details were finalized and contract signed. A sublicense agreement was also finalized with the Society of Japanese Pharmacopoeia as the Japanese Management Organization (JMO) for MedDRA.
The implementable version of the terminology, in English and Japanese translations, will be available for subscribers to license beginning on March 1, 1999.
It is expected that MedDRA will become the accepted standard for all regulatory activities. The terminology serves a vital public health need: to facilitate the collection, presentation and analysis of regulatory information on medical products during clinical and scientific reviews and marketing.
The remit of the BDM is to provide a set of services in connection with the maintenance, distribution, implementation and ongoing development of the terminology, to ensure that it continues to evolve in response to user needs. The MSSO Team will consist of a consortium of experienced international companies: BDM International, Inc., Quintiles Transnational Corporation, Stellar Business Systems and Cyntergy Corporation. Ernst & Young LLP will be retained to serve as knowledge management provider.
For further information about subscribing to MedDRA, contact Kathryn Huntley at BDM. E-mail: firstname.lastname@example.org
Geneva, 24 November 1998
Further information from: email@example.com
International Conference on Harmonisation
SIGNIFICANT PROGRESS ON ICH COMMON TECHNICAL DOCUMENT
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.
Tokyo, 4 September 1998
Press Report, February 1998
International Conference on Harmonisation
ICH Steering Committee Embarks on Phase Two Harmonisation
The ICH Steering Committee marked the start of a second phase of activities at a meeting held near Washington DC, 2-5 February 1998. New topics and working methods were adopted and significant progress was made on the Common Technical Document project for the registration of new medicines. At the same meeting, two important Clinical Guidelines, from the first phase of ICH activities, were finalised.
At the time of the Fourth International Conference on Harmonisation, Brussels, July 1997, the ICH Steering Committee confirmed its ongoing commitment to improve, through harmonisation, the efficiency of the process for developing and registering new medicinal products in Europe, Japan and the United States, in order to make these products available to patients with a minimum of delay.
Working methods are being established to ensure that in the second phase of activities the mechanism for harmonising new technical requirements resulting from scientific progress and developments in innovative drug research continues to function efficiently. In addition, a process has been drawn up for updating and supplementing the current ICH guidelines, when necessary, and monitoring their use, so that the benefits of harmonisation achieved so far will not be lost in the future.
It is clear that, in its second phase of activities, ICH will encompass topics with implications not only for new drug and biological/biotechnology products but also for established medicines, generic products and products for self medication. The Steering Committee will ensure that the ICH process accommodates an appropriate participation of interested parties in the consensus building discussions between experts which are pivotal to ICH activities. Arrangements have also been agreed with WHO to facilitate information exchange via WHO Regional Offices on subjects where ICH harmonisation activities may have wider global impact. This process will apply to the discussions of the Common Technical Document, a new topic adopted in July 1997.
The two new harmonised tripartite ICH Guidelines which will now be implemented by the regulatory parties to ICH are:
New Topics for harmonisation were discussed and it was agreed that work should commence immediately on Good Manufacturing Practices for Pharmaceutical Active Ingredients. The Steering Committee recognised other important initiatives already underway in this field. With the ICH commitment to this project, it is hoped to expedite the development of a single international set of principles which can be implemented globally and provide greater assurance of the quality of active ingredients used to manufacture medicinal products.
Among the other topics anticipated for inclusion in the future work programme of ICH are a guideline on the conduct of Clinical Trials in Children and a review of the ICH Guidelines on Stability Testing for New Drug Substances and New Products.
The Expert Working Groups on the Common Technical Document project met for the first time during the week. The objective of the project is to agree to an information package of technical data, in the same format and with the same content for the registration of a new medicinal product. The Steering Committee received extremely encouraging reports from the three Expert Working Groups which are considering quality, safety and efficacy aspects of the dossier. The current progress indicates that the target of reaching consensus within two years will be achieved.
On this basis, the Steering Committee will, at its next meeting in Japan, September 1998, consider plans for a Fifth International Conference on Harmonisation at the turn of the millennium, in the USA.
6 February 1998
Tysons Corner, Virginia
See ICH Topics for a full listing of ICH Guidelines and their Status.
Copyright© 1998 International Federation of Pharmaceutical Manufacturers Associations