[ICH M4: the standardized international restration dossier or "C.T.D." (common technical document)].
The ICH E3 guideline "Structure and Content of Clinical Study Reports" has allowed to harmonize the structure and the contents of the study report, as well as the information to be provided in each section. Industry has wished to pursue this process and has asked for an ICH guideline regarding the complete harmonization of the registration dossier, called "C.T.D." or Common Technical Document, for the three parts of the dossier in terms of quality, safety and efficacy. A survey was carried out comparing the documentation to be provided, identifying the differences and potential obstacles to harmonization, and assessing the advantages and disadvantages of the C.T.D. The C.T.D. leading to a single registration dossier should allow pharmaceutical companies and health authorities to make savings in terms of resources (time, money and expertise), to facilitate exchanges through IT systems and to improve communication. The ICH expert groups in charge of the pharmaceutical, pre-clinical and clinical parts of the dossier are expected to start their work in February 1998. By February 2000, it is anticipated that this project will become a valuable tool for the international registration and evaluation of medicines. The C.T.D. should improve the dialogue between industry and authorities with regard to medicines and public health.
de Cremiers
F
F
Worldwide Regulatory Affairs, WYETH-AYERST, European Clinical Research and Development.
D004345:Drug Industry / Q000592:standards*; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies / Q000592:standards*; D004364:Pharmaceutical Preparations / Q000592:standards*; D012449:Safety
D004364:Pharmaceutical Preparations
ICH M4: le dossier d'enregistrement international standardisé ou "C.T.D." (common technical document).