Introduction:
Following are the reasons for Post NOC changes:
·
To
improve the quality of the drug.
·
To
improve the efficiency of the manufacturing process.
·
To
solve marketing issues.
·
Changes
in the labeling of the drug for “warning” or managing the “risk factors” or
limiting the “targeted population” or limiting the “dosage”.
These drugs may
include pharmaceuticals, biologics, and radiopharmaceuticals for human use and
pharmaceutical, radiopharmaceutical and certain biotechnological products for
veterinary use.
Health Canada recognizes that:
·
any change to a drug may impact the safety, efficacy
and quality of that drug and;
·
any change to the information associated with the drug
(for example [e.g.], labeling) may impact the safe and effective use of that
drug.
To manage the safety and risks of the public in using
the drugs and foods, there are certain rules and regulations administered by
“Health Canada”.
One important area of these regulations are
administrative rules managing the “Post Notice of Compliance” (Post NOC) related
to a drug.
Post NOC provides sponsors with recommendations on the
data required to enable Health Canada to make an accurate determination of the
impact of a change on the safety, efficacy and quality of the new drug.
Level
of changes to a drug and subsequent obligations of the sponsor are as
followings Levels:
ü Supplements.
(Data should be submitted to Health Canada for review prior to implementation.)
ü Notifiable
Changes. (Data should be submitted to Health Canada for review prior to
implementation.)
ü Annual
Notifications. (Data should not be submitted but should be available to health
Canada upon request)
ü Record
of Changes. (Data should be retained by sponsor)
Reporting Categories:
Level I – Supplements:
These changes to a new drug are “significantly
different” as it relates to the matters specified in C.08.003 (2) of the Food
and Drug Regulations and have the potential to impact the safety, efficacy,
quality and/or effective use of the drug.
The changes included in this reporting category shall
be filed, along with the recommended supporting data, to Health Canada as a
Supplemental New Drug Submission (SNDS) or Supplemental Abbreviated New Drug
Submission (SANDS).
The change may not be implemented by the sponsor until a NOC has
been issued.
Level II - Notifiable Changes:
These changes to a new drug have the potential to
impact the safety, efficacy, quality and/or effective use of the drug but do
not require the issuance of a NOC.
(NOTE: All Level II - Notifiable Changes (Quality)
referred to in this document are not applicable to Human Pharmaceuticals)
The changes included in this reporting category should
be filed, along with the recommended supporting data, to Health Canada as a
Notifiable Change.
All Level II changes should not be implemented by the sponsor until
a No Objection Letter (NOL) has been issued!
Level III - Annual Notifications:
These changes to a new drug have minimal potential to
impact the safety, efficacy, quality, and/or effective use of the drug. The
changes included in this reporting category may be implemented by the sponsor
without the prior review by Health Canada of the data supporting such a change.
These changes should be annotated in the affected
documents when filing the next submission to Health Canada to indicate those
Level III changes that have been implemented.
The recommended supporting data should not be submitted but should
be available to Health Canada within thirty (30) calendar days if requested at
any time!
Level
IV - Record of Changes (Quality only):
These changes to a new drug are not Level I, Level II
or Level III and are not expected to impact the safety, efficacy, quality
and/or effective use of the drug. The changes included in this reporting the category may be implemented by the sponsor without prior review by Health
Canada.
The changes should be retained as part of the drug product’s record
by either the sponsor or the manufacturer and comply with Good Manufacturing
Practices (GMP) requirements of Division 2 of the Food and Drug Regulations!
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