Canada to Speed up Reviews of Generic Medicines

| 10 January 2013 |  By 

Canada's Therapeutic Products Directorate (TPD) has announced that as of 1 February 2013 it will be replacing the Integrated Review Process (IRP) that has been used for screening generic Abbreviated New Drug Submissions (ANDS) and supplements (SANDS) with updated screening criteria.

The aim is to better focus review resources on the review of complete submissions so as to reduce and ultimately eliminate the current backlog of generic drug submissions, Canadian regulatory officials said.

A key component to the new screening process will include an attestation checklist for use by generic sponsors that is intended to ensure that the key required information is being provided in the generic application. In the updated screening process, sponsors will also be required to confirm through the attestation form that Drug Master Files and the required Letters of Authorization have been provided. If the DMF is not in order (fees paid, accessible), a Screening Deficiency Notice (SDN) will be issued. The "Closed" portion of the DMFs will no longer be verified at screening.

The screening process will continue to be carried out in accordance with the Guidance for Industry: Management of Drug Submissions (MDSG). The sponsor will be notified of significant deficiencies revealed during screening via either a request for clarification or an SDN. Once all of the requested information has been received, the submission will be accepted for review.

Implementation of the updated screening criteria and the attestation form will start with all new ANDS and supplements received by the Office of Submissions and Intellectual Property as of 1 February 2013. The attestation form, however, will be accepted for submissions filed from 2 January 2013 onwards.


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Tags: ANDA

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