[Contribution of explanatory notes. Efficacy of the ICH plan for international clinical development of a new drug].
After the achievement of the Phase 1 of the ICH process (ICH4, Brussels, July 1997) and the recent adoption of two new Efficacy Guidelines (E5, E9) by the ICH Steering Committee, the Pharmaceutical Industry and CROs have today the necessary tools and standards of reference, to set up a Global Plan of Clinical Development for any New Molecular Entity for Human Use, within the three ICH Regions, Europe, Japan and the USA. However to achieve such a goal, the Efficacy Guidelines must officially be integrated in the Regulatory requests of each of the 3 ICH Regions ans implemented by Industry. The use of these Guidelines which concern the Clinical Development Plan and most of the content of the Clinical Documentation for Registration of New Medicinal Products, will show the qualities and defects of ICH texts, leading in the future to possible amendments, during the maintenance phase of these Guidelines (Step6 of ICH process?). The Efficacy texts cannot be separated from other ICH Guidelines concerning Quality, Safety ans above all the Multidisciplinary texts which are of great interest for the clinical development plan, registration and follow up after MAA of any New Medicinal Product. Referring to Ethnic differences between the three ICH Regions, topic E5 is the most innovative of Efficacy Guidelines for both Regional Regulatory Authorities, accepting or not foreign clinical data and International Companies, setting up Global Clinical Plan and Registration Dossier. The paper is also looking at the future impact of the other Efficacy (E10) and Multidisciplinary (M1 to M4) Guidelines which are still under consideration.
Husson
J M
JM
D004358:Drug Therapy / Q000592:standards; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies / Q000458:organization & administration; D007391:International Cooperation; D015337:Multicenter Studies as Topic
Contribution des notes explicatives. Efficacité d'ICH au plan de développement clinique international d'un nouveau médicament.