For any drug to be deemed safe for public consumption, it must first go through a life cycle of development. In Canada, this process is heavily regulated by the federal government, and must adhere to the guidelines of the Canadian Drug Review and Approval Process. Before any drug can be submitted to Health Canada for approval, it must undergo a series of phases, from preliminary research all the way to clinical trials.
But what exactly do these processes for verifying a drug’s safety and efficacy involve? And why is each step necessary? Here’s what those seeking clinical research careers should know about the drug development life cycle.
Early Stages and Overall Process
Before work can be done to develop a drug or other type of pharmaceutical product, research must first be conducted to better understand how certain diseases affect the body. During this preliminary research phase, the goal is to perform tests on thousands of different molecular compounds to find one that can provide the desired effect.
Once this has been completed, initial information regarding a proposed drug compound’s efficacy and safety is gathered based on a series of tests. Both this phase and the initial research can take a number of years to complete. Pending approval from Health Canada based upon pre-clinical trials, human clinical trials then begin. These trials take place in four phases:
- Phase I: small group of volunteers, verifies the drug’s safety and acceptable dosage
- Phase II: hundreds of volunteers, verifies its safety among a larger population
- Phase III: thousands of volunteers, watches for side effects and ensures drug’s efficacy
- Phase IV: a final round of testing done once the drug has already reached the market
Clinical trials are a prerequisite for the approval of any drug by Health Canada. These trials are designed to ensure that the drug is safe, effective, has the correct dosage, and that any adverse reactions to it are identified and reviewed.
Obstacles That Can Arise During Development
Those working in various clinical research careers will understand that many different things can arise during the efficacy and safety testing phase that may negatively affect or delay the drug development life cycle. One major obstacle is the occurrence of side effects and adverse reactions.
When this happens, a report must be sent to the federal government as soon as these effects or reactions occur. This can help identify issues with the drug’s safety, especially if these issues were previously rare or unapparent. In some cases, identified problems can halt a trial or cause the drug to be taken off the market in Canada entirely.
Additional challenges that can arise during the drug development life cycle include issues receiving sufficient funding, recruiting volunteers, and staying compliant with federal regulations throughout the process.
Approval and Distribution: What Those Wanting Clinical Research Careers Should Know
After all the phases of the clinical trials are complete, the drug may then be eligible for approval. For this to happen, Health Canada’s Health Products and Food Branch (HPFB) must first review the drug before authorizing it to go on the market.
Those getting their online clinical research diploma might be interested to know that when a drug is ready to be approved by Health Canada, the drug’s sponsor must file a New Drug Submission (NDS) to the HPFB with results from the studies. Once it passes a Risk/Benefit analysis and it’s deemed safe and effective, Health Canada can then decide whether or not to approve the drug.
Even after it has been approved and granted a Notice of Compliance, a sponsor must be assigned to the drug to ensure it adheres to market authorization requirements, and continues to abide by federal regulations.
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