Health Canada has released an updated version of Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations. According to Health Canada, the guidance document has been updated to reflect judicial consideration of “innovative drug” and current administrative practices, including requirements for submissions relying on third-party data, protection for products containing an innovative drug, biosimilars, and the six-month extension for data related to pediatric populations.
Revisions to the guidance document
Definition of innovative drug. The updated guidance document relies on the definition of innovative drug contained in the Food and Drug Regulations, i.e. a drug that contains a medicinal ingredient not previously approved by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph.
The guidance document sets out two requirements for data protection eligibility: (a) the drug must be a new chemical entity and (b) the data that supports the approval of the medicinal ingredient must have required considerable effort.
“Considerable effort” means that the approval is being sought on the basis of new and significant data (i.e. evidence to determine the safety, efficacy, properties and conditions of use of the drug, usually in the form of pivotal clinical trials).
The guidance document also states that where there is an “arguable variation” of a previously approved medicinal ingredient, but not a salt, ester, enantiomer, solvate or polymorph as specifically excluded from the definition of innovative drug in the Food and Drug Regulations, Health Canada will undertake an assessment of whether the variation is an innovative drug. Health Canada will then consider whether the data was generated with “considerable effort.”
Submissions relying on third-party data. The guidance document states that drugs reviewed on the basis of literature references, study reports of trials not conducted or sponsored by the applicant, books, consensus guidelines from professional bodies and/or market experience (i.e. third-party data) are not eligible for data protection. These amendments are likely being made further to Health Canada’s Guidance Document: Drug Submissions Relying on Third-Party Data, released in May 2015.
Drugs containing the same medicinal ingredient as an innovative drug. Where a drug contains one or more medicinal ingredients found in an innovative drug for which data protection is still in effect, the drug will benefit from the same period of data protection as the innovative drug. However, in order to benefit from the data protection term, there must be a relationship to the innovative drug. This does not apply to subsequent-entry drugs.
Biosimilars. The guidance document states that the six-year “no file” period prescribed by the Food and Drug Regulations (applicable to manufacturers seeking a notice of compliance on the basis of an indirect or direct comparison to an innovative drug) is intended to apply to biosimilar drugs. New drug submissions which are based on independent clinical trials and not on a comparison to an innovative drug are not captured by the six-year “no file” period.
Submissions that do not result in a subsequent-entry version of the innovative drug are not captured by the six-year “no file” period. For example, a submission for a drug indicated for use in combination with an innovative drug will not be prevented from filing.
Pediatric population extension. In order to be eligible for the additional six-month extension for drugs intended to treat pediatric populations, the innovator must provide the Minister with the description and results of clinical trials relating to the use of the innovative drug in pediatric populations in its first new drug submission or in any supplement to that submission filed within five years after the issuance of the first notice of compliance.
The clinical trials must be designed for the purpose of increasing knowledge of the use of the innovative drug in pediatric populations and this knowledge must provide a health benefit to the pediatric population.
Details of the study will be used to determine if the clinical trial was conducted for the purpose of increasing knowledge of use of the drug in pediatric populations. If the knowledge requirement is met, Health Canada will determine whether that knowledge is available to provide a health benefit. At minimum, the knowledge must be available to the public, e.g. through the approved labelling or Product Monograph.
Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations