New approach to quality for natural health products regulated by Health Canada

The Natural and Non-Prescription Health Products Directorate (NNHPD) has modernized the approach to quality to reduce regulatory burden on industry, harmonize with international bodies and allow judgment and discretion to be used to ensure high quality Natural Health Products (NHPs) are produced. A new Quality Guide has been published in 2013 to outline tools and approaches that can be used by license holders to produce high quality NHPs. This guidance document clarifies that the license holder is ultimately responsible for ensuring the quality of an NHP and that the submission of a signed Product License Application is now regarded as an attestation acknowledging the license holder's responsibility to meet the requirements set out in the Natural Health Products Regulations and associated guidance documents relating to quality and Good Manufacturing Practices (GMPs).

The Quality Guide describes the requirements for producing high quality NHPs; however, it allows for flexibility in how these requirements are met. License holders can substitute, modify or exclude any requirements specified in the guide, provided that scientific rationales are documented and maintained. These rationales should be based on GMPs, scientific principles and product history and experience. The review of this information may employ a risk-based approach that focuses on those elements of the application that most directly relate to safety.

Evidence that a product meets applicable quality requirements is verified through the assessment of GMP evidence provided in support of a site license application. By redefining the license holder responsibilities and ensuring compliance with GMPs throughout the life cycle of the product, this new approach to quality assure high quality NHPs while promoting a timely and efficient application review process.