Canada’s Winning Business and Regulatory Climate

Posted by Sam Ricchezza

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Manufacturing_Capabilities_You_Can_Trust.jpgDoing business in Canada offers tangible business benefits. In any country, contracting contract manufacturing services requires managing the legal and regulatory aspects particular to that country; fortunately maintaining a commercial relationship across Canadian borders is generally simple and straightforward. Canada offers pharma companies an ideal platform from which to access European and other markets as part of an international business strategy. 

Over the last 10 years, the U.S. Food and Drug Administration (FDA) has taken steps to better review and regulate companies regarding cGMP practices and is instituting more contemporary policies and practices pertaining to the manufacture of drugs. Similarly, Health Canada has been active in supporting the quality and safety of drugs manufactured in Canada through its regulatory activity. The agency is also collaborating more with other regulatory bodies such as the U.S. FDA and is becoming more involved in international drug manufacturing policy through the International Conference on Harmonization (ICH).

The Canadian government provides grants to encourage innovation and drug safety, placing emphasis on R&D and helping to introduce process analytical technology (PAT) and other groundbreaking technologies into the mix.

Health Canada’s core mission promotes drug safety through more effective formulations and efficient cGMP methodologies. Proactive compliance by CMOs is an operational imperative, integrating new technologies to ensure improved quality, and therefore drug safety and supply. Additionally, Health Canada regulatory audits facilitate the integration of advanced methods and technologies called for by the agency’s leadership.

Pharmaceutical Manufacturing Processes Guide Canada’s regulators have made a shift to be more responsive to pharmaceutical companies’ needs, while working with the FDA, EMA and PMDA to ensure a safe and abundant global drug supply. As a Canadian CMO, our ability to manufacture compounds at their highest quality is related in part to the stable, sustainable regulatory climate we operate under in Canada.

A sustainable regulatory effort is one that continues to evolve with the pharmaceutical industry, introducing regulation without squelching innovation and marketing momentum. Canada’s regulatory environment is just that: supportive and proactive, promoting a comfortable business climate for the pharmaceutical industry and its partners in the long term.

Topics: CMO Partner, open market, regulation, innovation

is the Vice President, Business Development for WellSpring Pharma Services. He has over 18 years of business development and marketing experience in the pharmaceutical contract development and manufacturing industry. He has held a number of progressively responsible business development positions over the course of his career with Patheon, DPT Laboratories, AAIPharma and WellSpring. Sam is also a member of “Contract Pharma’s” Editorial Advisory Board.

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