Generic Drug Approval Process In CANADA And USA PDF/PPT

Save (0)
Close

Recommended

Description

Generic Drug Approval
Process In CANADA And

USA

Department Of Regulatory Affairs

WWW.DULOMIX.COM 1

 

Generic Approval Process in Canada

➢ Upon receipt of the ANDS, the TPD will undertake a screening process
to ensure it is complete and in the appropriate format. This is an
administrative review and does not include any technical review of the
information.

➢ The TPD targets 45 calendar days to complete the screening of an ANDS.
Once the screening is complete and accepted, the submission enters the
queue for technical review.

➢ If the screening process identifies deficiencies in the ANDS, the sponsor
will receive a “screening deficiency notice”, and has 45 calendar days to
respond and resolve any identified deficiencies. Nowadays industries are
getting clarification in form of “Clarifax”.

WWW.DULOMIX.COM 2

 

WWW.DULOMIX.COM 3

 

➢ Once an ANDS for a generic product passes the screening process and is
accepted for review, the TPD has a target of 300 calendar days to
complete its evaluation.

➢ If TPD is not able to commence the review of a submission prior to its
performance target date, the sponsor will receive an Update Notice,
which provides an opportunity for the sponsor to update the file with
additional information.

➢ The sponsor has 30 days to decide and then notify the TPD if it will
submit additional information. The sponsor then has a further 60 days to
update its submission.

➢ During the review of a submission, a sponsor can receive a variety of
different types of letters requesting additional information.

WWW.DULOMIX.COM 4

 

Clarifax (clarification request)
A clarifax is a request to expand, clarify or re-analyze existing data. A sponsor has 15
calendar days to respond to a clarifax. If the sponsor is able to meet the timeframe for
response, the review will continue uninterrupted. The TPD has no limit on the number
of clarifaxes that it may issue in relation to a submission.

Notice of Deficiency (NOD)
➢ If there are significant deficiencies or omissions in a submission that preclude the

continuation of the review, the TPD will send an NOD.
➢ The sponsor has 90 days to respond to the matters identified in the NOD.
➢ When the response to an NOD is reviewed, if it is still found to be deficient, the

TPD will issue a notice of deficiency-withdrawal (NOD/w).
➢ The sponsor is required to withdraw the file from review but can re-file at a later

date without prejudice.
➢ If a sponsor disagrees with TPD’s decision, it can submit a request for

reconsideration.

WWW.DULOMIX.COM 5

 

Notice of Non-compliance (NON)
➢ After the review of a submission is complete, the TPD may issue an NON. This

letter indicates that the submission is deficient or incomplete. The NON lists
deficiencies from all parts of a submission (CMC).

➢ Only one NON is issued per submission, and the review stops on issuance of
the NON. A sponsor has 90 days to respond.

➢ If a sponsor fails to respond to an NON on time, or if the response is
unacceptable, the TPD will issue a notice of non- compliance withdrawal
(NON/ w).

WWW.DULOMIX.COM 6