The article says that the drug approval process in Canada is very slow and time consuming which not only makes it difficult to access new innovative drugs, but also affects medical care spending. It says that Canada should adopt a system for drug approval to facilitate speedy market access to...
Over the past decade the Canadian drug approval system has come under intensive scrutiny, with the greatest amount of attention being given to the length of time required to approve new drugs. This issue has obviously also been of considerable interest to the pharmaceutical industry, and the quest...
Background: Health Canada posts the outcomes of all New Drug Submissions. In some cases, companies have withdrawn submissions or submissions have been rejected by Health Canada for new active substances (NAS). This study explores the reasons for those decisions and compares them with decisions made...
Drug companies typically sell medications for far less in Canada than in the United States, as a result of Canadian government price controls. But because of safety and efficacy concerns, federal law prohibits consumers from buying drugs from outside U.S. borders except in rare cases. Politician...
“Four-plus conservative,” he calls it; an approach that led to an approval process that took more than three times as long as other drugs approved that year. It also resulted in a series of stringent, post-approval regulations that tightly controlled who could prescribe the drug, where ...
ANDA Post-approval Change Submissions Canada Health Authority Interactions Health Canada Query Management Our Capabilities MPR - Generics - Our Capabilities Menu Ensuring 'Right Opportunities' for 'Right Market' Breaking complex generics Regulatory Challenges Generic Application Expertise Drug Master File (DMF...
All clinical trials must be approved by the Institutional Ethics Committee also, and that approval takes 30 days. The need for a local trial may be waivered if the trial if for a drug already approved outside of Indi...
And in Canada, the most important clinical trial regulations include the Food and Drugs Act and its regulations that establish the legal framework for the conduct of clinical trials involving investigational drugs, biologics, and medical dev...
2022. “Incidence of neurological and psychiatric comorbidity over time: a population-based cohort study in Ontario, Canada.” Age and Ageing 51 (2). https://doi.org/10.1093/ageing/afab277. Nelson SJ, Zeng K, Kilbourne J, Powell T, Moore R. Normalized names for clinical drugs: RxNorm ...
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