Snapshot

The Path IV (new life saving drugs) pathway has been developed by the National Agency of Drug and Food Control  of Indonesia.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

Review Path: IV. Preregistration review: 1-12 months. Registration review: 100 working days. Clock stop: Maximum 120 working days. Administrative process (grant approval): 1-2 months. Maximum review time: 520 working day. *Clock Stop will take place if the evaluators request any additional data or any clarification or information to applicant. The process will stop until the applicant submits the additional data or clarification. The applicant cannot delay the submission of the additional data requested for more than 120 working days. When there is a delay in submission of data requested, the registration process will be rejected by NADFC. However, the applicant has the option to resubmit the dossier as a new registration application.