Navigating the aisles of the pharmacy can be overwhelming. A customer looking to purchase some acetaminophen to relieve their headache is confronted with shelves stocked full of different versions of the substance from a variety of different brands. Though they may be more familiar with the Tylenol product, there is no significant difference between it and the plainer versions of the drug sitting next to it. Functionally, both drugs are the same, though there is a good reason both exist.
Professionals who work in pharmacovigilance and regulatory affairs are invested in the compliance of pharmaceutical and healthcare products with the existing laws and regulations. These experts know that maintaining the safety and efficacy of pharmaceutical drugs is important. To understand the regulations governing Canada’s pharmaceutical industry, students seeking to work in regulatory affairs should know the differences between brand-name and generic drugs. Read on to learn more.
Why Both Generic and Brand-Name Versions of the Same Drugs Exist
The brand-name version of a substance is developed and produced first, by researchers working for a brand-name drug manufacturer. The costs of research and development can be very high, so to recoup this money, these companies file patents. These patents grant them exclusive rights to market and sell the drug for as long as they have patent protection. After the patent expires, a generic drug manufacturer can file to release their version of the same drug.
Because these drugs have substantially lower research and development costs, generic drugs tend to be significantly less expensive. The drugs are, however, functionally identical. They can differ from each other only in:
- Color, shape, and markings
- Taste and smell
- Inactive ingredients and preservatives
- Packaging and branding
The brand-name first version of the drug is known as the Canadian Reference Product (CRP), and all subsequent generics refer in their listing to the CRP. Those with careers in regulatory affairs assess these references in the generic manufacturer’s application.
The Safety of Generic Drugs, for Students in Regulatory Affairs Programs
Besides the superficial differences and the difference in cost, generic drugs are functionally identical to their brand-name equivalents. For a manufacturer to begin to produce and market a generic drug, they need to submit an Abbreviated New Drug Submission (ANDS) to Health Canada’s Food and Drug Regulations governing body. This helps ensure that the generic drug is safe to use.
The paperwork submitted for approval needs to prove a few fundamental things:
- That the generic drug is manufactured in accordance with Good Manufacturing Practices (GMPs)
- That the generic meets the same pharmacokinetic parameters in the body (i.e., it dissolves at the same rate and to the same extent as its brand-name equivalent)
- Data that proves its safety, efficacy, stability, purity, and strength
The generic drug and its brand-name counterpart must be assessed as bioequivalent by Health Canada standards. This means that it is considered a therapeutic equivalent, in that it follows the same pathways of distribution, metabolism, and elimination. Graduates of regulatory affairs programs may be those assessing these drugs’ quality compliance.
Why People Might Choose to Not Use Generic Drugs
There are four main reasons why a person might not take a generic drug in the place of a brand-name product:
- Misinformation around the efficacy of generic drug products
- Unavailability of a generic drug product
- Allergies or intolerances to non-active ingredients such as gluten or lactose
The province or territory doesn’t consider the drug interchangeable based on their policies and regulations, though they are bioequivalent
There is a pervasive myth that generic drugs are less effective or contain less active ingredient than their brand-name equivalents. This may be influenced by the perceived trustworthiness of household brands, and the lower price point of generic drugs. However, this is not true, as research indicates that they are functionally therapeutic equivalents. The other main barrier is the patent period for the brand-name drug. Within this period, which averages about 8 years in Canada, other manufacturers are barred from creating generic alternatives.
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