Common Drug Review Update — Issue 78

Clarifications and corrections to the Procedure for Common Drug Review and the Common Drug Review Submission Guidelines for Manufacturers

Procedure for Common Drug Review

The Procedure for Common Drug Review has been updated to include the clarifications and corrections noted in Table 1.

Table 1: Procedure for Common Drug Review
Change	Location
Clarification of patient input submission deadline date when manufacturer provides advance notice of submission: When CADTH receives notification of a pending submission, the patient input submission deadline date is calculated by adding the number of business days of advance notice (up to ten [10] business days) plus fifteen (15) business days (the usual time allowance for submitting patient input). This means that patient groups are given up to a maximum of 25 business days for filing a patient input submission when manufacturers provide advance notification.	Section 2.1(c)
Correction/clarification of pre-NOC* priority review submissions: Both Category 1 and Category 2 requirements are to be deemed complete before a manufacturer provides drug plans with copies of the submission, as described in Appendix 1 of the Common Drug Review Submission Guidelines for Manufacturers. *NOC = Notice of Compliance	Section 4.1(c)

Common Drug Review Submission Guidelines for Manufacturers

The Common Drug Review Submission Guidelines for Manufacturers have been updated to include the correction noted in Table 2.

Table 2: Common Drug Review Submission Guidelines for Manufacturers

Change

Location

Section 4.1.4 is clarified and section numbers are corrected, as follows:

When the Category 1 requirements in the manufacturer’s submission are deemed complete, CADTH sends an acknowledgement to the manufacturer and advises the participating drug plans. Upon receipt of the acknowledgement, the manufacturer must ensure that CADTH is provided with:

five (5) additional (for a total of six [6]) complete copies of the Category 1 submission requirements in electronic format on CD, DVD, or memory stick, as specified in Appendix 7F. (CADTH may request additional copies if required.)
for a submission for new drugs or drugs with new indications:
- five (5) hard copies of section 4.2.1 (f) Efficacy, Effectiveness, and Safety Evidence, and section 4.2.1 (g) Economic and Epidemiologic Information; OR
for a submission for pre-NOC priority review:
- five (5) hard copies of section 4.3.1 (g) Efficacy, Effectiveness, and Safety Evidence, and section 4.3.1 (h) Economic and Epidemiologic Information; OR
for a submission for new combination products (funded components):
- five (5) hard copies of section 4.4.1 (f) Efficacy, Effectiveness, and Safety Evidence, and section 4.4.1 (g) Economic and Epidemiologic Information.

Section 4.1.4