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Bill C-239

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2nd Session, 37th Parliament,
51 Elizabeth II, 2002

House of Commons of Canada

BILL C-239

An Act to amend the Food and Drugs Act (process for approval of new drugs)

R.S., c. F-27

      Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:

1. Section 30 of the Food and Drugs Act is amended by adding the following after subsection (1):

Criteria for new drug approval regulations

(1.1) Regulations made under paragraph (1)(o) that relate to the process for the testing and approval of new drugs must

    (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 not more than 300 days excluding time taken by the applicant to provide information requested for the review process;

    (b) provide an opportunity for the applicant to request that the application be given priority in review;

    (c) set out the criteria against which a request for priority review will be considered;

    (d) set out the stages of the review process and time guidelines for the completion of each stage of the process;

    (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;

    (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;

    (g) provide for the assignment of sufficient professional, scientific and other technical and support staff to ensure that the guidelines are adhered to;

    (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

    (i) prescribe the form and content of the reports to be made by the Minister to Parliament under subsection (1.2).

Report to Parliament

(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,

    (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;

    (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;

    (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;

    (d) the number of professional, scientific, technical and support employees assigned to the review process during the year; and

    (e) any steps the Minister intends to take to improve the process in succeeding years.

Confidential information protected

(1.3) A report under subsection (1.2) must not contain any information whereby an applicant or a new drug may be identified.