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NA LRA Watchdog - April 2022

  

North America Legal and Regulatory Affairs 
Watchdog Update
April 2022



By:
Sowmya Viswanathan, PhD

University Health Network and University of Toronto, Toronto CANADA


Health Canada and Environment and Climate Change Canada act on stakeholder recommendations to reduce regulatory burden

What’s happening?

In 2021, Bill C-28 was introduced to Canadian parliament to amend the Food and Drug Act and Canadian Environmental Protection Act (CEPA) through the Strengthening Environmental Protection for a Healthier Canada Act. The Bill was passed in the parliament but before it could be made into law, the government was prorogued for federal elections. The Bill, now called Bill S-5.has been re-introduced in February 2022 and is expected to pass shortly.

This Bill will streamline the environment review process for all drugs including cell and gene therapies that are in investigational trials or require market authorization.

How did this come about?

In 2019, Canadian academic and industry stakeholders held a workshop to address streamlining regulatory burden for environmental review of cell and gene therapy investigational products during clinical trial, and at time of market authorization under the New Substances Notification Regulations, as part of the Canadian Environmental Protection Act (CEPA). The workshop consisted of invited stakeholders including members of CellCAN, members of BIOTEC Canada, Health Canada and Environment and Climate Change Canada (ECCC).

Four recommendations emerged from this workshop.  Interested readers are referred to this peer-reviewed paper in Cytotherapy (Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada ) which highlights the regulatory burden and provides potential solutions.

One of the solutions was to amend the FOOD DRUG ACT to provide Health Canada with the authority to conduct environmental assessments for an application for a drug establishment license; an application for a clinical trial application for drugs, including cell and gene therapies; or an application for market authorization for drugs. Currently, such applications trigger an independent 120-day (streamlined to 30 days unofficially) review by ECCC. 

What’s the problem?

ECCC has the authority under the NSNR and CEPA to assess and regulate environmental impact of all living organisms that are manufactured or imported into Canada; the broad definitions of living organisms in the 1999 CEPA act covers all processed cell, gene therapies and gene-modified cell therapies.  The process for approval requires this review to be able to add the new living organisms to the Domestic Substances List within 120 days. However, the intent of the CEPA is not to regulate if equivalent provisions exist. This would be the case if the FOOD AND DRUG ACT had the authority to conduct an environmental assessment that would be equivalent to the provisions in CEPA. Since this was not the case, ECCC had to perform the independent review increasing regulatory burden and timelines for sponsors. 

Importantly the Food and Drug Administration (FDA) in the US does not have such an independent review process, opting instead to conduct the environmental assessment as part of a single review process for investigational new drugs. Sponsors are not required to duplicate the submissions or deal with another regulatory agency as part of the review process. Currently, sponsors or manufacturers/importers of Canadian clinical trial applications for cell and gene therapy products are required to submit a clinical trial application (CTA) to Health Canada and a separate information package for review by ECCC.

The workshop participants thus made a recommendation in March 2019 to amend CEPA and in parallel to amend the FOOD AND DRUG ACT to include environmental reporting and assessment requirements, to provide sufficient and equivalent environmental oversight to CEPA. In 2019, an Environmental Impact Initiative (EII), led by the Health Product and Food Branch at Health Canada was working on the legal implications of such amendments, and further collaborated with workshop stakeholders.

What is being done?

A number of legal reviews have been completed and the FOOD AND DRUG ACT is being amended so it can assess and manage environmental risks for drugs. This also gives Health Canada the authority to prohibit sale of a drug unless it has been assessed under these regulations.  The legal changes have been made in a such a manner that the environmental risk assessment that will be carried out under the FOOD AND DRUG ACT will be equivalent to CEPA

What does this mean?

When this bill is passed into law and receives royal assent, the requirements for new drug ingredients under NSNR of CEPA would be replaced with FOOD AND DRUG ACT and Food and Drug Regulations (FDR).  This would mean that the environmental assessment would be conducted through a single review window at the time of submitting a CTA, or an application for a drug establishment license or an application for a new drug substance, as may be the case.  A second submission package and timeline for review would no longer be required.

This is welcome news for all Sponsors conducting cell and gene therapy clinical trials and looking to market cell and gene therapy products in Canada. It reduces timelines, regulatory burdens and regulatory uncertainties for Sponsors. It harmonizes the Canadian regulatory review process with the US FDA environmental review process.

This is another win for active engagement with regulators.  It shows that stakeholder engagement and action does influence and accelerate policy change, at least in Canada. The regulatory agencies are to be commended for their diligence, openness, and collaboration in streamlining regulatory review processes and acting on stakeholder feedback.

For more information see: 

Forward Regulatory Plan 2021-2023: Regulations amending the Food and Drug Regulations for Environmental Risk Assessment and Management of Ingredients in Drugs

 This newsletter includes links to issues and activities that might be of interest both on the Health Canada as well as the FDA websites.  Please note that you can follow HC and FDA on Facebook and Twitter. You can also subscribe to receive emails from the FDA at https://www.fda.gov/about-fda/contact-fda/get-email-updates

Health Canada

What’s new in Biologics, radiopharmaceuticals and genetic therapies can be found at: https://www.canada.ca/en/health-canada/services/drugs-health-products/biologics-radio-pharmaceuticals-genetic-therapies/what-new-biologics-radiopharmaceuticals-genetic-therapies-health-canada.html

Information for health product manufacturers and distributors in relation to COVID-19:  https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry.html

FDA

What’s new for Biologics including Approval and Determination Letters:
https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/whats-new-biologics

COVID-19 Information and Resources:
https://www.fda.gov/emergency-preparedness-and-response/counterterrorism-and-emerging-threats/coronavirus-disease-2019-covid-19

Guidance Documents:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents


The Following new documents are of note:

Upcoming Conferences:
https://www.fda.gov/vaccines-blood-biologics/news-events-biologics/workshops-meetings-conferences-biologics

Updated Approvals and Listings:

Complete List of Licensed Products and Establishments

Complete List of Substantially Equivalent 510(k) Device Applications

Complete List of Currently Approved Premarket Approvals (PMAs)

Complete List of Currently Approved NDA and ANDA Application Submissions (PDF file)

2022 Biological Approvals 


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