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3 Questions About Generic Drugs Answered for Those Interested in Regulatory Affairs

pharmaceutical regulatory affairs
Generic drugs, despite how they may appear, are not very different from brand-name medicines. That’s because they’re designed to replicate the same dosage form, strength, quality performance, and intended use. They also produce the same effects, since both drugs contain the same active ingredients. 

Because they’re fundamentally alike, generic drugs can serve as an alternative version of the brand-name drug. The distinguishing feature comes from the different names. Typically, a brand-name drug is protected by a patent. When that patent expires, other manufacturers can reproduce the brand-name drug and sell a generic version of it. 

Interested in pharmaceutical regulatory affairs? Read on to discover the answers to some of the most common questions about generic drugs!

1. What Regulatory Standards Are in Place for Generic Drugs?

In order for manufacturers to produce and sell a generic drug in Canada, they must file an Abbreviated New Drug Submission (ANDS). This document highlights the specific ingredients and their amounts, how the drug will be made and tested during manufacturing, and how each lot of the drug will be tested before being distributed or sold. 

Professionals in regulatory affairs must also focus on bioequivalence. This means manufacturers have to show how both drugs share biochemical similarities and produce the same outcome for patients. The generic drug submissions are then reviewed by experts in the Health Products and Food Branch (HPFB), which conducts:

  • A thorough review of the submitted information
  • An evaluation of the data for assessing the drug’s potential risks and benefits
  • A test to determine whether or not the drug meets regulatory requirements
  • A review of the information to be provided to health care practitioners and consumers e.g. labels and brochures
regulatory affairs

Pharmaceutical regulatory affairs ensure that generic drugs go through a thorough evaluation process

Once the drug passes these tests and meets all regulatory requirements, the drug is given a Notice of Compliance (NOC) and a Drug Identification Number (DIN). This allows manufacturers and sponsors to market and distribute the drug in Canada.

2. How do Professionals in Regulatory Affairs Ensure Efficiency and Safety?

Demonstrating bioequivalence is key when ensuring a generic drug’s efficiency and safety. This proves that there are no significant differences between them. This results in the same bioavailability–how quickly medical ingredients are absorbed and used by the body. Clinical trials are conducted to test this bioavailability and then submitted to Health Canada for review.

regulatory affairs program

Clinical tests are done to evaluate bioequivalence between generic and brand-name drugs

Health Canada also takes active steps to guarantee safety. Scientists and clinicians in the HPFB evaluate reports from various stakeholders and regulators, as well as health professionals and consumers. If any issues come up with the generic drug, the HPFB:

  • Publishes and distributes new safety information 
  • Changes the product’s label
  • Removes the product from the market
pharmaceutical regulatory affairs

Healthcare providers and consumers are given safety information if issues are identified with generic drugs

3. Why Are Generic Drugs Designed and Priced Differently?

Professionals in pharmaceutical regulatory affairs may have noticed that generic drugs look different from brand-name drugs. Although both drugs share the same active medical ingredients, they may have different characteristics and nonmedical ingredients. This can lead to different colours, shapes, and flavours. Generic brands may also choose to create their own symbol for the drug.

In terms of price, generic drugs may cost less because manufacturers are able to skip the lengthy clinical studies needed to create the original drug. Because these studies have already been conducted, manufacturers go through a much more streamlined regulatory process—the “Abbreviated” New Drug Submission. It should be noted that lower marketing costs may also contribute to the generic drug’s lower price. 

Despite these differences, approved generic drugs ultimately work in the same way as brand-name drugs, making them a great substitute.

Are you interested in starting a regulatory affairs program?

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