An updated “Guidance for Industry Preparation of the Quality Information for Drug Submissions in the CTD Format: Biotherapeutic and Blood Products” is available effective April 29, 2024. This guidance documents combines three CTD guidance documents applicable to conventional biotherapeutic products into one.
CPID-B
Completed CPID-B is now included as required during filing of an NDS. The previous guidance stated this the CPID-B was only required if requested by the specific departments, however in practice, it has always been required and now this requirement appears in the guidance. Additional sections have been added to the CPID-B. Some examples are provided below:
In S.2.2, information on batch size / scale, reprocessing and hold times added as required information.
S.5, S.6, S.7.2 added as new sections to be included in the CPID-B.
Upon implementation, HC is requesting the Product Life Cycle Management Document be included in 3.2.R.8.
QOS-B
A blank QOS-B template is now available with the intention that the QOS-CE is not used for biological applications. Using the QOS-B template is not mandatory, however its use will reduce clarification requests for missing information.
Additionally, Health Canada has decided that rather than providing an annotated QOS for post-approval changes, an updated version of the QOS with only sections affected is required. Previously, an annotated QOS containing all sections was required. The CTD section numbering and format should still be kept the same in the updated version of the QOS.
The guidance also clarifies that biosimilarity assessment should be provided in the QOS in addition to under 3.2.R.5. And that process validation and method validation is not required for CTAs and CTA-As.
Module 3 – Quality
Clarifications have been added for multiple drug substance and drug product sections.
Examples of clarifications are:
In S.2.1, it should be clarified if the facility involved in testing is responsible for compendial / non-compendial testing. If there is more than 1 site for testing, the specific tests performed at each facility should be included.
In S.2.3, it is now confirmed that the qualification protocols used to generate MCBs and WCBs should be submitted.
Health Canada's updated guidance for biologics is great news for the industry as it provides clarifications and templates specific to biologic drug submissions which will lead to less clarification requests from the appropriate directorate.
Regxia has supported several clients with their submissions to the BGTD. If you have questions about your product’s regulatory pathway in Canada, our team can help.
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