In this edition of the Weekly Compliance Digest, we cover amendments to Canada’s regulations on pharmaceuticals.
Regulations Amending the Food and Drug Regulations (Vanessa’s Law)
What is it?
On April 21, 2017, Health Canada proposed new regulations that would allow the Department to identify, assess and respond more quickly and effectively to safety issues that emerge after a drug comes on the market. The regulations are part of an effort to enhance the monitoring of the safety of new drugs authorized for use in Canada, and take action more promptly if new risks are identified. The new regulations are provisions of “Vanessa’s Law” (the Protecting Canadians from Unsafe Drugs Act) that did not come into effect immediately when the law was passed in 2014.
Under the proposed regulations, Health Canada would be able to require companies to conduct new tests or studies, or to compile new information and report back to the Department. Companies will also be required to notify Health Canada of any actions requested or required by a regulator in another jurisdiction such as risk communications, label changes, recalls, or licence suspensions. Failure to comply could result in companies being subject to increased fines and penalties which have already come into force under Vanessa’s Law.
Who is affected?
The proposed regulations apply to companies that place prescription or over-the-counter drugs on the Canadian market. According to an OH&S magazine article, the amendments don’t apply to natural health products, which continue to be regulated under the existing Natural Health Product Regulations of the Food and Drugs Act.
What are the provisions?
The proposed regulations give Health Canada more regulatory tools and powers, which could impact companies, including:
- Ordering a drug company to make a label change if a safety risk has been identified once a drug is on the market.
- Ordering the recall of a product if the Department believes that it presents a serious risk of injury to health.
- Ordering a company to conduct an assessment of a product and provide the Department with the results.
- Ordering a company to compile information, conduct tests or studies or monitor experience in respect of a product and provide the Department with the information or results.
In addition, drug companies will be required to provide Health Canada information regarding any serious injury to health that companies become aware of, and information that is relevant to the safety of the drug, including:
- Risks communicated by certain foreign regulatory authorities.
- Changes to the labeling communicated to, or requested by, certain regulatory authorities.
- Recalls, reassessments, suspensions or revocations of authorizations within certain foreign regulatory jurisdictions.
The information would be required to be provided to Health Canada within 48 hours after receiving it, or becoming aware of it, in order to allow the Department to follow up without delay if similar risks exist for those drugs in Canada and action would be required to mitigate those risks.
What is next?
The proposed amendments will come into force six months following the publication of the Regulations in the Canada Gazette, Part II (Official Regulations). The amendments are currently published in Part I (Notices and Proposed Regulations).
Visit Enablon Insights again next Friday for a new Weekly Compliance Digest!
View the recording of our webinar “Pharmaceutical Spotlight: EHS Compliance Landscape & Effects on Products and Intermediates” with ERM and 3E Company to learn more about business trends and challenges affecting the Pharmaceutical industry.