Health Canada is introducing a new plan to modernize the Drug Establishment Licensing (DEL) framework over the coming years. This plan, divided into two phases, focuses on strengthening regulatory oversight, aligning with international standards, and easing administrative burdens.
Before going into details of the update, let’s throw light on what DEL is and who needs it.
What is Drug Establishment Licensing (DEL)?
Health Canada’s Drug Establishment Licensing (DEL) is a regulatory framework that governs the licensing of establishments involved in the drug manufacturing and distribution process in Canada. The DEL program is designed to ensure that drugs and related products meet high standards of quality, safety, and efficacy before they are available on the Canadian market.
Click here to learn more about DEL.
Who Needs DEL?
- Manufacturers: Facilities that produce, package, or label drugs must obtain a DEL to ensure compliance with Good Manufacturing Practices (GMP).
- Distributors: Establishments involved in the import, export, and distribution of drugs also require a DEL.
- Importers/Exporters: Entities involved in importing or exporting drugs must hold a DEL to ensure adherence to regulatory requirements.
Want to know why Drug Establishment Registration (DEL) is important for you? Read this blog.
2024 DEL Updates
Here’s a breakdown of what DEL updates in 2024 by Health Canada mean and how they will impact your businesses and consultants involved in drug establishment licensing in Canada.
What is the Drug Establishment Licensing Framework?
The DEL framework governs the licensing of businesses that manufacture, package, label, import, distribute, and wholesale drugs in Canada. This framework ensures that drugs available to Canadians are safe, effective, and of high quality.
Phase 1: Enhancing Drug Recall and Testing Regulations
The first phase of Health Canada’s plan includes several important updates:
- New Drug Recall Framework: A structured regulatory framework will be established for recalls ordered by the Minister of Health. This will streamline the recall process, ensuring faster and more efficient action to protect public health.
- Clear Reporting for Voluntary Recalls: Businesses will have clear guidelines on their obligations for reporting voluntary recalls, aligning with current policies to improve transparency and accountability.
- Updated Mutual Recognition Agreements (MRAs): Outdated references to regulatory authorities in mutual recognition agreements will be replaced with a dynamic list accessible on the Government of Canada website. This makes it easier for businesses to stay up-to-date with recognized authorities.
- Testing Exemptions for Advanced Therapies: Conditional exemptions will be introduced for certain biologics (like gene and cell therapies) and radiopharmaceuticals from some finished product testing requirements. This will apply where alternative safety controls are in place, supporting the development and accessibility of these advanced treatments.
- Direct Shipment Provisions: Clarification that certain biologics and radiopharmaceuticals can be directly shipped to healthcare practitioners or facilities. This helps ensure timely access to critical treatments.
Phase 2: Streamlining Licensing and Compliance
The second phase will focus on reducing the regulatory burden and modernizing compliance measures:
- Simplified Annual Licence Review: The annual review process for establishment licences will be simplified, reducing the administrative workload for businesses and Health Canada.
- Modern Compliance Tools: Provisions related to compliance and enforcement will be updated, including the use of terms and conditions and suspensions. This will provide a more flexible and effective regulatory framework.
- Flexible Oversight: Less prescriptive regulations will be introduced, maintaining appropriate oversight while allowing more flexibility in regulated activities. This approach aligns with a risk-based regulatory philosophy, focusing resources where they are most needed.
Benefits 2024 DEL Updates for Businesses and Consultants
Enhanced Efficiency: The updated recall framework and clear reporting obligations will help businesses manage recalls more efficiently, minimizing disruptions and protecting their reputations.
Simplified Compliance: By updating MRAs and introducing conditional exemptions, Health Canada is making it easier for businesses to navigate regulatory requirements, particularly for advanced therapies.
You should know that MRAs are formal agreements between countries or regions to accept each other’s regulatory evaluations and certifications for certain products, services, or processes.
Reduced Administrative Burden: The streamlined annual licence review and modern compliance tools will significantly reduce the time and effort businesses need to spend on regulatory processes.
International Alignment: Aligning Canada’s regulations with those of major international partners like the U.S., EU, UK, Australia, and Switzerland will facilitate smoother trade and regulatory processes, benefiting Canadian businesses operating globally.
What’s Next?
Health Canada has been actively engaging with stakeholders throughout this process:
- Initial Consultations: Between April and June 2019, Health Canada consulted with DEL and Medical Device Establishment Licensing (MDEL) holders.
- Notice of Intent: In December 2021, a notice of intent was published in the Canada Gazette, Part I, followed by a 60-day comment period.
- Public Comments: Proposed changes for Phase 1 were pre-published in the Canada Gazette, Part I on April 15, 2023. During the 75-day comment period, Health Canada received feedback from 46 respondents, including individuals, businesses, and associations.
Publication Timeline:
- The final regulations for Phase 1 are expected to be published in the Canada Gazette, Part II in spring 2024.
- Proposed amendments for Phase 2 will be pre-published in the Canada Gazette, Part I in winter/spring 2025, followed by another 75-day comment period.
By modernizing the DEL framework, Health Canada aims to enhance drug safety, streamline regulatory processes, and support the growth of the pharmaceutical industry in Canada.
Businesses and consultants should prepare for these changes, which promise to bring greater clarity, efficiency, and international alignment to the regulatory landscape.
How Quality Smart Solutions can help you
At Quality Smart Solutions, we’re dedicated to helping you stay ahead of regulatory changes. Our team of experts is ready to guide you through the new DEL framework, ensuring your drug establishment practices meet the latest standards. Contact us today to learn how we can support your regulatory needs!
