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Hello @manufacturer @agency Process flow is a business decision. PAAB has adjusted its requirements for Medical/Regulatory sign-off to respect this fact. What's changing? PAAB will no longer require med/reg review to occur prior to initial PAAB submission. Upon submitting, if you have opted not to complete Medical/Regulatory review prior to PAAB review, please click "Not Yet" on the submission form. If Medical/Regulatory review was completed, you will continue to have the option to confirm this and provide the Manufacturer Medical/Regulatory contact. Click here to more about why, new form requirements, and what this means for the review process. Question? Post below and we'll get back to you. Thanks PAAB

Companies have created "pro" websites where they house information on disease states (educational content) as well as products and we understand that the website "shell" with the "common" information will be one submission and each product page would be its own submission. My question is about disease state information/medical education. If a company wants to include CME content on a page of the website (completely separate from the product page/information), does it need to be submitted to PAAB to determine if it would be exempt? I've seen on one website that has this type of set-up that the website "shell" and product pages have the PAAB logo, but the disease information page does not.

Hey @mhouzer The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.

Good Afternoon @Manufacturer and @Agency It's crazy to say but we're now just past halfway through 2025! The PAAB Quarterly Tag and CEI Reports have been updated to contain data for Q2. See the Tag report here and the CEI report here. The Forum Quarterly Review for Q2 has also been posted here. If there's more you'd like to know in Q3, let us know in the comments below. Have a wonderful rest of the summer. Thank you PAAB

Lets start with a quick registration video.

Hey @ALee The same approach of “where applicable” should be applied to the RAMQ coverage as well. The intent of the inclusion is to ensure that the user is clear about the criteria for coverage as outlined by RAMQ. If the definitions and notes clarify or set the limitations/context for interpretation, they should be included.

Hey @dmauri Great question. As long as the study publication does not contain information suggesting dosing practices inconsistent with Canadian labelling, the manufacturer’s Medical/Regulatory Affairs department can confirm that the dosing in the jurisdiction where the study was conducted is the same as it is in Canada. When it comes to “SoC”, per 1.7 of the Guidance on Real-World Evidence/Data, remember that pooled comparisons are not acceptable which would render the second half of the question moot. However, if you are referring to SoC in a single-arm study (per Advisory: RWE Single-Arm Studies of Previously Treated Patients), we would look to ensure that the overwhelming majority of patients were on a product available in Canada/indicated in the same population in Canada. Regarding "SoC", please note the guidance's remarks on representing the marketplace versus exclusions by design. An opinion can be a great mechanism to get specific guidance on an individual study as it allows for assessment of the study design, therapeutic area, and indicated product(s).

Can we use a stability study designed for our biosimilar since the reference drug information in the product monograph does not reflect our data? Are there exceptions to the standard requirement of reflecting the product monograph for biosimilars?