Regulatory affairs is a blanket term for the processes that regulate industries. The pharmaceutical and medical device industries, energy sector, and banking, among others, all work within the confines of federal regulation to bring their products and services to market. The success of a company’s regulatory affairs department relies less on federal regulations, and more on the interpretation and application of said rules. In Canada, the main governing body regulating pharmaceuticals is Health Canada.
Under the Food and Drugs Act, Health Canada regulates, evaluates, and monitors the safety, efficacy, and quality of the 13,000 therapeutic products currently on the Canadian market. This includes oversight at all stages of a product’s life cycle, from early testing through clinical trials to post-market surveillance of adverse drug reactions and compliance monitoring.
To ensure they are able to meet Health Canada’s regulations, each company in the pharmaceutical industry must have a regulatory affairs team. Regulatory affairs teams are responsible for: 1) overseeing clinical trials; 2) ensuring products are made in compliance with legislature; 3) organizing and managing scientific data; 4) ensuring storage and labeling of a product is done within regulations; 5) ensuring the company meets strict deadlines; and 6) communicating with Health Canada regarding clinical trial applications.
Before a company can proceed with a clinical trial, it requires approval for the importation and sale of the unapproved product for the trial’s purpose. The Health Minister has the clear authority to reject, suspend, or cancel a clinical trial. If the trial provides evidence that the harm outweighs the benefit, the Minister may cancel the trial. Thus, applications to perform a clinical trial are required at each stage. The applications for Phase I, II, and III clinical trials fall into a default system; the Minister has 30 days to raise objection to the trial, after which the trial is free to move ahead.
After Phase III clinical trials have been completed, and a product has been shown to be safe, effective, and stable, the company submits an application to Health Canada for approval of the product for Canadian use. It can take upwards of 24 months for Health Canada to approve a drug; during this time they review the evidence and weigh the benefits and risks of the product. In the meantime, companies continue to supply supplementary information on new indications and manufacturing changes.
Once the product has been successfully brought to market, Health Canada ensures companies comply with ongoing responsibilities such as reporting adverse drug reactions, preparing annual safety reports, and managing any changes to the benefit-risk profile. If decided unfavorable, products may be withdrawn from the market.
Although a lengthy process, regulatory affairs are an essential aspect of the pharmaceutical industry. Canadians can be assured the drugs that are brought to market and prescribed to them have succeeded because they have been proven to be safe and effective. As the nature of pharmaceuticals has been changing – from small compounds to engineered T cells – it begs the question of how the future of regulatory affairs will also change. Future safety considerations may regulate the mutations introduced into patient cells and the use of potentially disease-causing agents in order to stimulate an immune response.
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