Canadian Guidance Clears Up Reconsideration Timelines
Pharmaceutical companies can expect to wait about 165 days for Health Canada to make a final decision on appeals of an approval or rejection of a drug, according to guidance last week that sets specific timelines for every step of the dispute resolution process.
Under the guidance, a company filing a letter to dispute a finding will receive a response within five days from the agency’s Food and Drugs Act Liaison Office. Within 45 days, the company must return a formal Request for Reconsideration, which Health Canada promises to acknowledge no more than 20 days later.
The company and the agency’s review bureau then have a week to provide nominees for a reconsideration panel consisting of one member nominated by the company and two from the review bureau and FDALO. The panel meeting will be held within 60 days of finalization of its members, Health Canada says. The agency’s Office of Science will then prepare a summary of the process and its analysis and recommendations for follow-up actions within two weeks.
The agency’s Office of Regulatory Affairs will set a target date for completing the review. This date will vary on a case-by-case basis, the guidance notes.
The rest of the guidance updates are procedural in nature. Many of the administrative functions, such as responding to sponsors’ inquiries and reviewing letters of intent, have been transferred to FDALO.
The agency has decided to drop a couple of steps in the process. The Summary Basis of Reconsideration Decisions, for example, no longer exists because it was seldom used and was difficult to put together without giving away commercially confidential information, Health Canada says. The agency has also dropped its Scientific Advisory Committees from the process because their work will be carried out by the reconsideration panel.
Read the guidance at www.fdanews.com/04-02-15-reconsiderationguidance.pdf. — Lena Freund