Health Canada has unveiled its Forward Regulatory Plan for 2024-2026, outlining significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act.
These amendments are designed to align the regulatory approach for self-care products, ensuring a streamlined and risk-based framework that reflects contemporary standards.
To better understand the proposed amendment, it’s essential to first understand Natural Health Products (NHPs) and Non-Prescription Drugs.
What is NHP?
Natural Health Products (NHPs) are a category of health products regulated by Health Canada. These products include a variety of items that support health and wellness through natural means. The category of health products include:
- Essential nutrients that support overall health and wellness.
- Herbal remedies or plant-based products used for their medicinal properties.
- Products based on homeopathy, a system of alternative medicine.
- Medicines used traditionally, such as those from traditional Chinese medicine or Ayurvedic medicine.
Click to learn how you can get an NHP Licence for Nicotine Pouches in Canada?
What is non-prescription drug?
Non-Prescription Drugs are medications that can be purchased without a prescription from a healthcare professional. These drugs are also known as Over-the-Counter Drugs or OTC drugs. These drugs are made to treat common, self-diagnosed conditions and symptoms such as pain, fever, coughs, colds, and allergies.
Examples of OTC drugs are Pain Relievers and Fever Reducers, Cough and Cold Remedies, Allergy Medications and Antacids and Acid Reducers.
Click this link to learn more about non-prescription drugs, how you can sell it in Canada, and more facts about it.
Now, let’s explore Health Canada’s Forward Regulatory Plan 2024-26 and outline significant amendments to the Natural Health Products Regulations and the Food and Drug Regulations under the Food and Drugs Act.
Health Canada forward regulatory plan: key changes proposed
- Simplified Pathways and Alignment:
Health Canada proposes a new system to fast-track approval for lower-risk non-prescription drugs. This system will align these OTC drugs with natural health products that have similar uses. The goal is to streamline the process while still ensuring that safety standards remain high.
- Modernization of Natural Health Products Regulations:
The amendments also target the Natural Health Products Regulations, introducing a structured risk-based categorization system and enhanced quality oversight measures.
Key proposals include:
- Annual Notification Requirement: Businesses will be required to annually notify Health Canada of marketed natural health products, enhancing transparency and regulatory oversight.
- Good Manufacturing Practices (GMP): Strengthening requirements for GMP will ensure that natural health products meet high standards of quality throughout the manufacturing process.
- Risk-Based Site Licensing: Introducing a risk-based site licensing program will enhance oversight of production facilities, further safeguarding product quality and consistency.
These amendments are in response to recommendations from the Commissioner of the Environment and Sustainable Development’s 2021 audit, underscoring Health Canada’s commitment to addressing regulatory gaps and enhancing consumer confidence in natural health products.
International alignment and impact
While these changes aren’t part of a formal international cooperation plan, they will bring Canada’s regulations closer to those of the U.S., EU, and Australia. This alignment should make it easier for Canadian businesses to compete globally and ensure imported products meet Canadian standards.
What it means for businesses and consumers
The proposed amendments are expected to impact businesses involved in the sale and manufacture of natural health products and non-prescription drugs in Canada.
- For natural health products, the amendments promise strengthened oversight and improved assurance of product quality, aligning with global best practices.
- Meanwhile, amendments to the Food and Drug Regulations aim to maintain robust regulatory oversight while reducing administrative burdens and enhancing operational efficiencies for businesses.
Consultations and stakeholder engagement
Health Canada has engaged stakeholders extensively since 2016 and will continue to do so throughout 2024. The recent publication of regulatory amendments in the Canada Gazette, Part II on July 6, 2022, marked a significant milestone in this ongoing consultation process. These consultations are crucial for gathering feedback from industry stakeholders, healthcare professionals, and the public to ensure that the regulatory framework remains responsive and effective.
Get assisted by Quality Smart Solutions
For detailed insights into these regulatory changes and ongoing consultations, reach out to our team of former Health Canada experts at Quality Smart Solutions. We help ensure compliance with modernized regulations governing natural health products (NHPs) and non-prescription drugs, enhancing safety and quality standards across Canada while facilitating business growth and innovation.
