Comparative Dossier Filling Procedure In The Asean, Cis And The Gcc Region

Transcript

Dossier is a file document submitted based on the requirement of the drug approval process. It is a comprehensive scientific document used to obtained worldwide licensing approval of a drug by diverse health authorities. Its creations, processing, compilation & dispatch to the field by a regulatory affairs department, is dependent upon many interrelated activities the filling process in the emerging markets will be depends upon the region .In the Asean region A-CTD filling procedure in GCC region CTD format and CIS countries will be NeeS filling procedure will be follow. After compilation 1 copy of the dossier will be submitted to the regulatory authorities for the registration of the drug product.