The use of RWE to inform regulatory decision has been an adopted concept by global regulatory agencies, when, where and how to use the data from a real world setting to contribute to a product label or approval throughout its life-cycle continues to be a heated debate. Release of concept papers and a more detail structural outline through an RWE framework from key regulatory agencies have provided industry with some guidance regarding how RWE can be used for new drug approvals or indication expansions. However, a review of recently approved products applying RWE to support regulatory filings suggests inconsistent review standards being applied. While drug manufactures are excited about the opportunity, many questions still are still. The recent release of two notices by Health Canada in collaboration with its health technology assessment partners to invite industry to submit RWE as part of a regulatory filing is exciting and welcoming news to the industry and early feedback will be communicated at the session.
This CAPRA featured session will also cover the topic on the Plain Language Labelling (PLL) Regulations. The drug labels and packages are the first points of interaction between a health product and a healthcare professional or patient. They communicate key information about the safe and proper use of health products, and are important aids in product identification, selection and administration. Through Health Canada’s Plain Language Labelling Initiative, the Plain Language Labelling Regulations have been introduced with the intention of improving the safe use of drugs by making drug labels easier to read and understand. When designing product labels and packages, it is important for sponsors, manufacturers and license holders to ensure that all labelling and packaging regulatory requirements per the Canadian Food and Drugs Act and Regulations are met and designed with their user in mind.