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Life-cycle Management
A well-designed regulatory framework recognizes the critical points in the life cycle of a drug, connects the phases in between those points, and supports information collection, analysis, and communication. While Health Canada's current regulatory process does intersect with drugs at different points during their life, it is at discrete points in time. The progressive licensing model would connect all of the points.
Current Point-in-Time Process
Progressive Licensing Model
Increased Knowledge
The life cycle of a drug begins with its development by the manufacturer. The manufacturer conducts non-clinical experiments to characterize the structure and activities of the drug. Testing proceeds to cells and animals to learn how the drug interacts with biological systems. Health Canada has opportunities at this point to learn about the manufacturer's plans for clinical testing of the drug on humans. Knowledge gained at this point will provide foresight into the Clinical Trial Application (CTA) and New Drug Submission NDS.
The information required for a CTA could be expanded to include the manufacturer's complete plan for development of the drug. This would enable Health Canada to take a more comprehensive approach to evaluating a clinical trial and enhance Health Canada's understanding of the drug during the NDS review.
The significant amount of work that a drug manufacturer puts into an NDS results in hundreds of volumes of scientific and clinical information. Health Canada reviews this information to make a decision about the safety, efficacy, and quality of the drug. If the drug meets the standards of evidence in these three areas, the review of the NDS results in Health Canada issuing a Notice of Compliance (NOC) authorizing the manufacturer to bring the drug to market.
Continuous Monitoring
Some types of information about a drug are not available prior to marketing. This information includes rare adverse reactions, interactions with other drugs, long-term effects, and effects on patient groups not included in the clinical trials. Hence, the ongoing collection and analysis of information about a drug after it is brought to market is crucial. The information gathered during this phase can change the assessment of the benefits and risks associated with a drug.
A drug can be withdrawn from the market, either by the regulator or by the manufacturer. However, the information that has been generated by the drug can be preserved and used in developing or improving other drugs.
Extraordinary Needs
Some special drugs are developed to meet extraordinary needs and decisions regarding them may have to be based on limited information. These may be drugs for rare diseases, drugs for use in emergencies, for compassionate access (see the discussion paper, Single-Patient Compassionate Access to Non-marketed Drugs), or be promising new therapies (discussion paper, Regulatory Options for Evaluating Promising Therapies). By their very nature, limited or no human clinical information may have been generated for these drugs. Information on these drugs evolves through their use and is essential to their regulation. Collecting and analyzing data on drugs addressing extraordinary needs is challenging, but must be achieved in a progressive licensing framework.
Pharmacovigilance
Pharmacovigilance is the process of detecting, assessing, understanding, and preventing adverse reactions or any other problems with drugs. In the past, pharmacovigilance has been implemented after a drug has been marketed and usually only after the identification of a safety concern. Earlier planning to detect adverse reactions and better approaches to managing risks can result in better patient care and reduce the need to withdraw drugs from the market. Planning for pharmacovigilance is occurring in some countries as early as the non-clinical testing stage. The progressive licensing model may incorporate pharmacovigilance planning at an early stage in drug development. See also the discussion paper, Pharmacovigilance Planning.
Communication
Effective and timely communication of new information is an important element of life-cycle management. As the regulator, Health Canada may have information prior to other decision makers. A progressive regulatory system is built around information, so it is necessary to provide structured support for communication. Drug information can be complex and the communication of it must make it accessible and useful. The progressive licensing model will support the involvement of users in the sharing and communication of information and realize that different users will have different needs.
Contact information for the Progressive Licensing Project.
