Developing an innovative healthcare product (a drug or a biologic or medical device) from the proof-of-concept stage to the marketing stage is an expensive and complex process, involving many years of research and development work.

In order to save time and money when bringing your product to market, there are several product development activities that must be done in accordance with the regulatory requirements that govern your product. Following these requirements can streamline development activities and help you to manufacture a product that will meet the regulatory standards of your targeted jurisdictions—that is, a quality product that is safe and effective for its intended use.

Although the regulatory requirements (for example, laws, guidance documents and international standards) for healthcare product development are readily available, navigating through the regulatory system is not simple, and it gets even more complex when you are dealing with multiple jurisdictions.

Entrepreneur’s Toolkit: Life sciences – Regulatory Guide

To help entrepreneurs who are developing healthcare products, MaRS has developed a Regulatory Guide that can be found in the life sciences section of the Entrepreneur’s Toolkit. This guide is a collection of short articles on regulatory-related issues that may be encountered during healthcare product development. Written in plain language, the guide aims to facilitate the regulatory understanding that governs product development and ensure regulatory compliance in these activities. It can be used as a starting point to assist you in developing your product.

Rather than serving simply as a compilation of regulations, the Regulatory Guide discusses the fundamental concepts and principles in regulatory affairs. Through the use of examples and illustrations, it helps to connect the interrelated activities involved in product development.

The Regulatory Guide is intended to be an educational tool that provides you with a road map for product development. Due to the wide variety of healthcare products, the constant advancement of scientific technologies and the ever-changing regulatory requirements, this guide does not replace the actual reading of the regulatory requirements published by regulatory and international bodies, nor does it substitute any specific advice from a qualified regulatory professional who can add value that is more specific to your product.

The Regulatory Guide contains the following subtopics:

  • Healthcare product development
  • Interacting with regulatory agencies
  • Product-related efficacy
  • Product-related quality
  • Product-related safety
  • Regulatory documentation and submissions
  • Regulatory submission processes: Canada, US, EU
  • Unlicensed and licensed products: Advertising and promotion

Navigating the Regulatory Landscape for Healthcare Product Development

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How to use it?

If you are not familiar with the product development life cycle, you may want to start with “Healthcare product development: 10 key steps” and its related articles. This set of articles outlines the development and maintenance activities that are generally applicable for innovative healthcare products.

The other sections of the Regulatory Guide contain discussions on the activities that support product development. If you are interested in a specific area, you may want to check out individual topics such as how to interact with regulatory agencies; the activities related to product efficacy, quality and safety; the industry practices in regulatory submission compilation; the typical regulatory processes required to legally bring products to the market; as well as the key principles related to the advertising and promotion of your product.

Next steps

Once you understand the regulatory concepts and principles related to your product, tailor them to your development program. Start collecting regulatory requirements, study them and implement them as applicable. For instance, if your product does not require a formal clinical study, you may skip Step 7 and move on to Step 8 as discussed in “Healthcare product development: 10 key steps.”

As you move through the development process, make sure to monitor, evaluate and implement any applicable changes in the regulatory requirements and adapt them to your development program.

Best of luck developing your healthcare product!

Carol Tsang

Carol is a consultant at RegConsulting helping companies to develop optimal regulatory strategies, prepare submissions and obtain registrations for healthcare products in the Canadian and international markets. See more…