Notice: Revision of Guidance documents: Conduct and Analysis of Comparative Bioavailability Studies & Comparative Bioavailability Standards: Formulations used for Systemic Effects

June 8, 2018
Our file number: 18-104623-884

Health Canada is pleased to announce the revision of two guidance documents, entitled Conduct and Analysis of Comparative Bioavailability Studies and Comparative Bioavailability Standards: Formulations used for Systemic Effects.

Changes to the documents in this revision include removal of guidance on the use of urine data for bioequivalence assessment and inclusion of guidance on highly variable drug products and multiphasic modified release drug products.

The Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products (April 18, 2016) will be superseded by these guidances when they come into effect. A draft of the section on multiphasic modified release drug products was released for consultation in July 2017. Stakeholder comments on this section have been considered in this revision. These comments together with responses from the Therapeutic Products Directorate have been collated in a separate document, which is available upon request. Requests for this document should be directed to the email address below.

These guidance documents will come into effect for submissions filed on or after September 1, 2018.

Any reduced requirements articulated in these two guidance documents would apply immediately should an application be filed prior to September 1, 2018.

Questions or concerns in this regard or related to the Guidance Documents: Conduct and Analysis of Comparative Bioavailability Studies and Comparative Bioavailability Standards: Formulations used for Systemic Effects should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
1600 Scott Street
Holland Cross, Tower B
2^nd Floor, Address Locator 3102C5
Ottawa, Ontario
K1A 0K9

Telephone: 613-948-4623
Facsimile: 613-941-1812
E-mail: hc.policy.bureau.enquiries.sc@canada.ca