Planning and Execution of Dossier Compilation of Countries Germany, Canada and Australia

Abstract

To prepare and compile the Dossier required for Registration of Pharmaceutical Products as per the requirements of each countries which shall be acceptable internationally to develop one regulatory approach. To avoid variation in the documents submitted in the form of dossier for registration of Pharmaceutical Products in the different countries of the world it’s important to know the requirements of Regulatory Authorities of each countries in which the Dossier is filled for the smooth Registration. When submitting your drug benefit assessments to the German Authority or other (foreign) regulatory agencies, you need to provide your reports in a specific format. . Drug  regulatory affairs  in pharma  industries  have  mandated  two types  of  dossier  namely  CTD  (Common Technical  Dossier)  and  ACTD  (Asean Common  Technical  Dossier).  Regulated pharma markets (eg.USA, Europe) markets require  submission  of  dossier  in  CTD format  which  has  to  provide  clinical  trial and  bioequivalence  studies.  As  against this,  semi-regulated  pharma  markets (South  East  Asian)  require  ACTD  format which  does  not  require  exhaustive  details like  CTD.  For  industries,  it  has  eliminated the  need  to  reformat  the  information  for submission  to  the  different  ICH  regulatory authorities.