ABSTRACT:

  The drug approval process varies from one country to another. In some countries, only a single body regulates the drugs and responsible for all regulatory task such as approval of new drugs. New drug will not be imported, except under the permission granted by the Licensing Authority. However in some counties all tasks are not performed by a single regulatory authority, such as in India, this responsibility is divided on Centralised and State authorities. Other issues where the difference appears are, time taken for the approval of a CTA application, time taken in evaluation of marketing authorization application, registration fee, registration process and marketing exclusivity. Some countries have two review processes as normal review process and accelerated review process as in USA, China etc. and some countries have only a single review process as in India. Similarly, the format used for the presentation of dossier submitted for approval of drug is also different. In some countries like as in USA, EU, and Japan, it is mandatory that the dossier prepared in CTD format, however, in some countries it is optional such as in India. In order to have easy understanding of all the three CTD, ACTD and Indian Requirement for Dossier Submission in various countries an overview of its differences and similarities is shown in the current article. It gives a clear idea how by some modification in reports one can apply for registration in all countries