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1st Session, 37th Parliament,
49-50 Elizabeth II, 2001
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House of Commons of Canada
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BILL C-338
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An Act to amend the Food and Drugs Act
(process for approval of new drugs)
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Her Majesty, by and with the advice and
consent of the Senate and House of Commons
of Canada, enacts as follows:
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1. Section 30 of the Food and Drugs Act is
amended by adding the following after
subsection (1):
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| Criteria for
new drug
approval
regulations
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(1.1) Regulations made under paragraph
(1)(o) that relate to the process for the testing
and approval of new drugs must
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(a) establish a process that provides for the
process of application, review and
notification to the applicant of a decision as
to whether or not a new drug will be
approved within a period of no more than
300 days excluding time taken by the
applicant to provide information requested
for the review process;
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(b) provide an opportunity for the applicant
to request that the application be given
priority in review;
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(c) set out the criteria against which a
request for priority review will be
considered;
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(d) set out the stages of the review process
and time guidelines for the completion of
each stage of the process;
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(e) provide a process for the applicant to be
notified forthwith if the guideline for any
stage is exceeded by more than ten percent
and require reasons to be given to the
applicant for the delay;
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(f) ensure proper consideration of similar
processes established outside Canada and in
particular ensure that the process is no less
efficient and timely than the process
established for the approval of new drugs in
the European Community by the European
Agency for the Evaluation of Medicinal
Products;
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(g) provide for the assignment of sufficient
professional, scientific and other technical
and support staff to ensure that the
guidelines are adhered to;
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(h) establish rules to ensure that the
scientific staff are not subjected to any
pressure to approve or not approve a drug on
the basis of any factor that is not directly
supportive of the public interest in having
access to safe, effective and economical
drugs; and
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(i) prescribe the form and content of the
reports to be made by the Minister to
Parliament under subsection (1.2).
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| Report to
Parliament
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(1.2) The Minister shall, on any of the first
three sitting days following April 1 of every
year cause to be laid before the Senate and the
House of Commons a report showing, in
respect of the preceding year
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(a) the number of applications for the
approval of a new drug for which the review
has been completed and the decision made
and transmitted to the applicant;
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(b) the average time for the review in each
case from the date of receipt of the
application to the date on which the
applicant was sent notice of the decision;
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(c) the number of applications for which the
time mentioned in paragraph (b) exceeded
the time set in the guidelines by more than
ten per cent and the most common reasons
for the excess time taken;
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(d) the number of professional, scientific,
technical and support employees assigned
to the review process during the year; and
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(e) any steps the Minister intends to take to
improve the process in succeeding years.
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| Confidential
information
protected
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(1.3) A report under subsection (1.2) must
not contain any information whereby an
applicant or a new drug may be identified.
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