Multiple Regulatory Challenges for Cross Border Sales of U.S. Pharmaceuticals, Medical Devices

A U.S. pharmaceutical manufacturer looking to expand to the Canadian market will need to ensure that all product labeling meets Canadian requirements, which often vary from U.S. requirements.

For one thing, Health Canada requires that directions for use be printed both in French and English, since Canada is officially a bi-lingual country.  And special care must be taken to list all product ingredients, manufacturer details, dosage/use  information and, if the product is imported, the name of the manufacturer and distributor must appear on the label.

If any of Canada’s labeling requirements or conditions for use differ from U.S. requirements, the U.S. Food and Drug Administration requires the manufacturer to state, on the label, that those conditions are not approved in the United States.

Sounds like a crowded label, right?

In fact, the regulatory burden for U.S. pharmaceutical and medical device manufacturers was listed as the top supply chain concern of industry executives in a recent study.  But it is not the only issue.  Changing demographics, namely the aging of the U.S. population and the increasingly global marketplace are also putting strains on the traditional supply chain.  The expiration of several lucrative patents, which led to a surge in generic drugs is another factor that has caused manufacturers to look for efficiencies.

Purolator International takes a detailed look at all trends affecting U.S. health product manufacturers’ supply chains in a new white paper, “U.S. Pharmaceutical and Medical Device Manufacturers:  Supply Chain Trends and Canadian Cross Border Efficiencies.”

As the paper makes clear, one of the most important decisions a supply chain manager will make, is choosing the right logistics provider to oversee all logistics and compliance issues.  Surprisingly, many managers do not do the necessary legwork, and learn too late that its “experienced” logistics provider does not have what it takes to move highly-regulated, highly-sensitive shipments of drugs across the border to Canada.

To learn more, please click here to download a copy of “U.S. Pharmaceutical and Medical Device Manufacturers:  Supply Chain Trends and Canadian Cross Border Efficiencies.”