EMA 新活性物质的化学指南 2004.2 英文.pdfVIP

The European Agency for the Evaluation of Medicinal Products Evaluation of Medicines for Human Use London, 17 December 2003 CPMP/QWP/130/96, Rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) GUIDELINE ON THE CHEMISTRY OF NEW ACTIVE SUBSTANCES DISCUSSION IN THE QWP October 2003 ADOPTION BY THE CPMP December 2003 DATE OF COMING INTO OPERATION February 2004 Note: This guideline replaces Note for Guidance on Chemistry of New Active Substance CPMP/QWP/130/96. It has been revised to change the location of the definition of active substance starting material from S.2.2 to S.2.3, as agreed in ICH CTD-Q-IWG. Public 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 8595 E-mail: QWP@ EMEA 2003 Reproduction and/or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged GUIDELINE ON THE CHEMISTRY OF NEW ACTIVE SUBSTANCES Note for Guidance concerning the application of Directive 2001/83/EEC with a view to the granting of a marketing authorisation for a new medicinal product. INTRODUCTION This guideline has been prepared in accordance with the new structure agreed for the quality part of the dossier, (Format ICH-CTD) . The subheadings have been included for