DrugMasterFileProcedures.ppt

Jean-Louis ROBERT National Health Laboratory L – 1011 LUXEMBOURG CHMP co-opted member Chair CHMP/CVMP QWP Beijing, March 30, 2010 * Submission of Data: Module 3, Certificate of Suitability, AS Master File Module 3: full documentation on the API (AS) is provided in the file for MA Certificate European Pharmacopoeia (CEP): AS described in the European Pharmacopoeia (EP) can undergo certification procedure in order to confirm compliance with the EP AS Master File (ASMF): Restricted part submitted by the AS Manufacturer Applicant’s part submitted by AS Manufacturer and Applicant For a pharmacopoeial substance in all cases compliance with the monograph has to be demonstrated whatever the route of submission. * Overview of topics addressed References EU ASMF: principle Content of the guideline How to use General considerations Recommendations Conclusion * References Directives 2001/83 EC as amended Guidelines: Active Substance Master File Procedure (ASMF) Summary of Requirements for Active Substances in the Quality Part of the dossier Various guidelines in relation to the Active Substance Active Substance Master File (ASMF)/European Drug Master File (EDMF): synonymous See EMEA website: www.emea.europa.eu * Structure ASMF Module 3.2.S S1 General Information S2 Manufacture S3 Characterisation S4 Control of Drug Substance S5 Reference Materials S6 Container Closure System S7 Stability * ASMF Guideline - Structure Introduction Content of the active substance master file Use of the ASMF procedure Content of the MA dossier when the ASMF procedure is used Changes and updates to the ASMF Annex 1: Overview EDMF contents Annex 2: Template letter of access Annex 3: Part of covering letter Annex 4: List of abbreviations * Within Scope New active substances Existing active substances (pharmacopoeial/non pharmacopoeial) Herbals * Out of Scope Biological Active Substances Excipients including novel excipients AS mixed with an excipient unless necessary for the stability of the ac