Healthcare is a public welfare endeavor and all the governments across the countries strive for better healthcare facilities and policies for the citizens. One of the important attributes is to improve market access for various treatments and therapies at affordable costs. As the drug development is a long process once available, its accessibility for patients gets impacted by differences in drug development and approval procedures between the nations. The developed countries from the European Union and North America possess one of the most stringent regulatory authorities compared to the rest of the World. An important country from this league of nations is Canada. Canada’s pharmaceutical market ranks as one of the largest in the world, and it is an important and active contributor to the country’s healthcare economy. Prescription medications, over the counter (OTC) medications, vaccinations, biologics, and medical devices are all part of it. Prior to being made available to the general public, pharmaceutical products, including both synthetic and biological drugs, must first pass through a thorough and stringent regulatory framework known as the drug approval process in Canada. This procedure is administered by Health Canada, the federal health agency charged for protecting and improving Canadians’ well-being and overall health. A review of data from 2002 to 2016 has revealed that new medications were frequently approved by the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA) before applying for Health Canada (HC) approval. Sponsors should take into account HC’s requirements, a significant global regulatory body, when attempting to commercialize a novel drug.
Canada is also a part of ICH countries and therefore all newly developed medicinal products must comply with the ICH guidelines. The federal department of HC is in charge of tightly overseeing clinical drug trials carried out in Canada to guarantee the efficacy and safety of both synthetic and biological drugs, medical devices, and other healthcare interventions including diagnostics and veterinary medicines. The regulatory specifications set forth by this agency for clinical drug studies mandates the evidence of clinical efficacy and safety in their population and thus including Canadian sites for global clinical studies is necessary. In addition to examining and approving clinical trial applications (CTAs), HC also keeps an eye on current trials to ensure that they are complying with all applicable regulations. The filing of a comprehensive clinical trial plan, informed consent forms for trial participants, and routine reporting of trial data to the department are among the requirements for drug studies. Therapeutic safety monitoring and pharmacovigilance regulations are strictly complied with in the Canadian healthcare system.
The length of time it takes HC to approve a drug in Canada can differ significantly depending on a number of variables, including the drug’s complexity, the quality of the submission, the kind of drug (synthetic or biological), the availability of data, and the particular circumstances surrounding the application. From preclinical development to market approval, the full drug approval process can take anywhere from a few years to more than ten years. It’s crucial to remember that some medications, particularly those that treat critical diseases or unmet medical requirements, may qualify for expedited review paths, which could speed up the approval process.
