Bibliographic record
Abstract
This study measures delays in the approval of new medicines by Health Canada and provides patients with the information they need in order to determine whether the time they wait for access to new medicines in Canada is unnecessarily long.Our findings reveal that Canadian approval delays are not insignificant. The most recent estimates calculated show that Health Canada took a median of 355 days to issue a notice of compliance for patented medicines in 2011 — an improvement from the 448 days it took in 2010. Between 2007 and 2011, Canadians could generally expect a delay of nearly a year or more for access to new medicines after submission for approval. That delay was longer than experienced in Europe for most years during that period. It was also longer than experienced under the US FDA for between two and four of the five years studied.While the requirement for governmental approval for sale is not unique to Canada, the process can add further delays for Canadians seeking treatment from these new medicines. An important question that arises from this comparison is the value of duplicating the application of safety standards between jurisdictions. Given the similarity of international safety standards and the relatively small size of the population served by Health Canada’s mandatory approval process, Canada’s federal government could improve access to new medicines through international harmonization and mutual recognition agreements.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.009 | 0.048 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.003 | 0.001 |
| Scholarly communication | 0.003 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.016 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".