Zdrowie i gospodarka · 11.02.2000
International Conference on Harmonisation; M4 Common Technical Document; Request for Comments on Initial Components; Availability
The Food and Drug Administration (FDA) is announcing the availability of initial components of a draft guidance \1\ entitled "M4 Common Technical Document," which is being developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Because of the large size of the draft guidance, FDA is making some components of the draft guidance available to the public at this time to help explain the overall scheme of the draft guidance and to request comments. When completed, the guidance entitled "M4 Common Technical Document" will describe a harmonized format and content for designated new product applications for submission to the regulatory authorities in the three ICH regions. The agency intends to make the entire draft guidance available to the public for comment once all the components have been drafted. ---------------------------------------------------------------------------