We had our bi-annual Cell Therapy Stakeholder Group (CTSG) meeting with Health Canada on Dec 07, 2017. The CTSG was expanded to include representation from the Regenerative Medicine Alliance of Canada, including the Stem Cell Network (SCN) and the Ontario Institute of Regenerative Medicine (OIRM), in addition to the usual participation from CellCAN, the Centre for Commercialization of Regenerative Medicine (CCRM) and the International Society of Cellular Therapy (ISCT).
8 Agenda items were presented and discussed at this meeting. Approved meeting minutes are available in the CTSG page on CellCAN’s website.
- The first agenda item included a revised Terms of Reference which was amended to include RMAC representation, have a single point of contact from each participating stakeholder group although multiple participants could be included. Dr. Sowmya Viswanathan from University Health Network and University of Toronto was re-affirmed as the chair. The involvement and participation of ISCT was re-affirmed.
- Health Canada presented metrics on Clinical Trial Applications and No Objection letters in the area of cell and gene therapy. Health Canada’s analyses of orphan drugs and accelerated pathways indicates they are competitive with other jurisdictions including European Medicines Agency (EMA), Food and Drug Administration (FDA) and PMDA even though there are no prescribed pathways for orphan drugs or accelerated pathways (NOL) in Canada. There was discussion on minimally manipulated autologous therapies, and the lack of clarity around their regulation and practice in Canada. Health Canada was referenced to a workshop sponsored by SCN and CCRM at the CellCAN Strategic Forum in March 2017 and the consensus outcomes from this workshop (Read et al., Cytotherapy, 2017). Stem Cell Tourism was briefly discussed and deferred for further discussion to the next meeting.
- The New Substance Notification Regulation (Organism) was discussed including opportunities for sponsors to take advantage of waivers, have free pre-notification consultation (PNC) meeting with Environment and Climate Change Canada (ECCC). It was noted that this regulation is represents a significant burden to sponsors and is not harmonized with other jurisdictions such as the US where the environmental risk assessment is seamlessly conducted as part of the investigational new drug (IND) review process. Recommended action item included a workshop led by CellCAN (Drs. Bubela and Viswanathan) in partnership with BIOTEC Canada to create practical solutions for sponsors to comply with existing regulations.
- Environmental Impact Initiative (EII) of the Health Product and Food Branch at Health Canada also talked about proposed regulatory amendments to the Food and Drug Regulations (FDR) which would allows environmental risk assessment to be conducted under FDR instead of NSNR under the Canadian Environmental Protection Act (CEPA). If this proposed amendment moves forward, it would come into effect in 2020-2021 after a public consultation process. CTSG stakeholders welcomed this development as it would lead to a single-window review, aligned with other practices in other jurisdictions. CTSG recommended including these proposed amendments in the workshop on NSNR(O).
- Pre-clinical study requirements and how these requirements are specific to indications, specific risk-profiles and are currently based on interpretations of the regulations on a case-by-case basis. CTSG appreciated the case-by-case review but did stress that lack of specific guidelines can cause confusion, delays and uncertainty. Health Canada strongly recommended taking advantage of their free pre-CTA consultation meetings. The timing of such meetings was discussed; typically, the meetings are too early if the hypothesis is not fully developed and questions are general, the responses will also be general. Health Canada also talked about requirements for Good Laboratory practice studies, small vs. large animal studies, the continuum of pivotal animal studies once clinical trials had been initiated, the need for toxicity studies and their duration, and common gaps in CTAs. Details on this discussion can be found in the Health Canada meeting minutes.
- Requirements for standardized labeling of advanced medicinal products was discussed. International Society of Blood Transfusion (ISBT) has developed standardized terminology, labeling and barcoding of products of human origins. The group discussed need for consensus terminology and components. Health Canada clarified that ISBT 128 labeling is not mandatory for blood for transfusion or cell-based products for transplantation. Health Canada can work closely with a stakeholder-led initiative involving manufacturers of cellular therapy products but couldn’t lead such an initiative itself to generate voluntary, consensus standards.
- Engagement with Canada online and through pre-CTA meetings was discussed. Health Canada clarified that web renewal is underway. There was discussion that the stakeholders could produce a FAQ section on their websites. CellCAN offered to host such an initiative.
- The last item included a presentation on the Tri-Council Policy Statement (TCPS) Public Consultation on research involving human cell lines. Proposed changes included new exemption from REB review for research that relies exclusively on human cells or cell lines where:
- the cells and cell lines are non-identifiable
- the research is not reasonably expected to result in re-identification
- the human cells and cell lines have ethical provenance
Feedback was requested as part of the consultation process.
The meeting concluded with a round-table discussion and proposal for a spring 2018 meeting.
The next meeting is scheduled for April 24, 2018.