In This Paper, I Am Going To Discuss About The Premarket
1428 WordsApr 15, 20176 Pages
In this paper, I am going to discuss about the premarket approval process for pharmaceuticals from its drug development to ultimate approval conducted in Canada and United States. The main intention of Canada (Health Canada) and United States(USFDA) is safety and well-being of public.
The Overall Process/steps of drug development to its approval in Canada and United states is almost same it differs in there authorities also the main difference is, In Canada during the drug development process prior to the beginning of a clinical trial, if the preclinical tests conducted indicate a substance produces the desired result and is not toxic, than the person or company who takes responsibility for application should apply to HPFB for…show more content…
Whether these preclinical tests states that a substance produces the effective desired effect and will not be toxic, the sponsor as mentioned above, applies to HPFB for authorization or permission to conduct a clinical trial in Canada.
HPFB is national authority which regulates, evaluates and monitors the safety efficacy and quality of therapeutic and diagnostic products available to Canadians. These products consist of drug, medical devices, disinfectants and sanitizers with disinfectant claims. Further the HPFB reviews the clinical trial application and gives permission to distribute the information to investigators that are mentioned in application. The clinical trail application submitted to HPFB consist of information of dosage, production methods, preclinical results and information of investigators involved in conducting experiments. After these clinical tests are conducted on humans after successful results of clinical trials the sponsor can file for new drug submission, which will be discussed in Part D.
Part B drug development process in United States.
The Act established in 1938 Federal Food, Drug and Cosmetic Act regulates the approval of new drugs in United States. The drug