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Interim Order Respecting Clinical Trials Relating to COVID-19

On May 23, 2020, the Minister of Health of Canada approved an Interim Order (IO) Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19. The IO aims to facilitate clinical trials for potential COVID-19 drugs and medical devices, while upholding strong patient safety requirements and validity of trial data. Under the IO, Health Canada aims to review COVID-19 related clinical trials applications within 14 days.

The Interim Order applies to:

  • new COVID-19 related drugs and medical devices that are not yet licensed in Canada or other jurisdictions
  • new COVID-19-related uses for existing drugs and devices licensed in Canada

This Interim Order does not apply to

  • radiopharmaceutical drugs
  • natural health products
  • Class I medical devices.

Requirements under the IO:

  • To sell or import a COVID-19 drug/device for the purposes of conducting a clinical trial, the applicant must submit a Clinical Trial Application (CTA) to seek Health Canada authorization prior to the initiation of the trial.
  • Before the COVID-19 drug/device can be imported or sold or before the clinical trial commences, the authorization holder must have obtained approval from the Research Ethics Board at each site
  • The clinical trial must be conducted in accordance with internationally recognized Good Clinical Practices.
  • Authorization holders must submit significant changes in respect of the drug/device being studied to Health Canada for authorization prior to implementing these changes.

Regulatory flexibilities under the IO:

  • Reduced administrative requirements for assessing the use of existing marketed products as possible COVID-19-related therapies
  • Allow alternate means of obtaining informed patient consent to facilitate virtual trials and infection control in the context of COVID-19.
    • remote written informed consent
    • non-written informed consent obtained through reading the contents of the informed consent form to the trial participant and receiving the individual’s informed consent before a witness, and subsequent attestation by the witness that the consent was given.
  • broaden the range of qualified investigators
    • expanded to include other health care practitioners, such as nurse practitioners, pharmacists and midwives
  • expand the range of applicants who are able to apply for a medical device clinical trial authorization
    • an application may be submitted by not only manufacturers and importers but also others such as clinicians, academia, contract research organization, etc.
  • Support greater decentralization of trials to multiple/remote sites
  • Facilitates a broader range of trials that may not otherwise have been authorized or allows the ability to further address uncertainties or mitigate risks.

If you or your company is interested in learning what is needed to meet the regulatory requirements or is looking to submit an application for authorization of a clinical trial under the IO, now is the time act. Quality Smart Solutions has a team of specialists who can help you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 13 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation
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Clarifications and requirements regarding the interim measure for Hard Surface Disinfectants and Hand Sanitizers

In light of the current COVID-19 pandemic, Health Canada is taking action to increase supplies of disinfectants and hand sanitizers. Regarding the interim measure currently in place for hard surface disinfectants and hand sanitizers, Health Canada has recently provided the following clarifications and additional requirements.

Labeling requirements

  • Packaging of imported product may be in
    • French-only or,
    • English-only or,
    • English or French and another language
  • Importers are required to post the bilingual label text (English and French) on their website. This website should not contain any additional advertising or claims outside what is authorized for these products.
  • Importers must provide sellers with a means to inform consumers, at time of sale, of where they can access bilingual information on the product. For example, a sticker applied directly to the products, posters, or signage with take-away pamphlets at the point of sale.
  • Domestic manufacturers of these products must use bilingual labelling on the product.
  • Products previously accepted with unilingual labelling under the interim measure will be required to move to bilingual labelling by June 8, 2020.
  • These requirements apply to both DIN or NHP products

Expiry of interim measure

  • Health Canada is monitoring supplies of these products to ensure that Canadians have access to products that limit the spread of COVID-19. Health Canada will lift this interim measure when the regular supply stabilizes.

Relaxed requirements

  • A Drug Establishment Licence (DEL) is not required to import or sell:
    • DIN hand sanitizers
    • DIN hard surface disinfectants considered antimicrobial agents.
  • Health Canada can authorize:
    • use of technical grade ethanol in the manufacture of hand sanitizers
    • the distribution of hands sanitizers containing technical grade ethanol provided that the supplier of the technical grade ethanol is on an approved list.

Health Canada is facilitating the importation of the following disinfectant and sanitizer products: 

  • Products that are already authorized for sale in Canada but are not fully compliant with Health Canada requirements.
  • Products that are not authorized for sale in Canada but are authorized or registered in the United States, or an MRA country, or a PIC/s country.
  • Importers of these products are required to notify and submit information to Health Canada prior to importation
  • For alcohol-based hand sanitizers, the grade of alcohol used
  • the official language on the product label (French or English or Both)
  • if applicable, the website where the bilingual product label can be found, and the method to be used to inform the consumer at point of sale of the website
  • a copy of the product label that will be distributed in Canada
  • Valid DEL or SL number, if available
  • Name of the logistics company to be used

If you or your company is looking to market your COVID-19-related disinfectants and hand sanitizers in Canada, now is the time act. Quality Smart Solutions has a team of experts who can provide product licensing, label compliance, and import solutions for you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting over 500 clients worlwide for 14 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices, OTC drugs in Canada, United States and Mexico. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

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News

Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices

Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices for use by healthcare providers, including diagnostic test kits. This Interim Order will help ensure quicker and more flexible approval of the importation and sale of medical devices that are necessary for Canada’s response to COVID-19.

Nucleic acid amplification testing is the diagnostic technology used by public health laboratories across Canada and around the world for diagnosis of COVID-19 infection. As such, diagnostic tests using nucleic acid technology are being prioritized for review to increase the number of tests available in Canada to detect active infections of COVID-19. 

Devices using serological technology are also being accepted for review. However, this type of testing is not currently recommended by the World Health Organization as it do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection which can delay the detecting from days to weeks.

The expedited authorization pathways under the Interim Order

  • new COVID-19-medical devices that are not yet licensed in Canada or other jurisdictions,
  • existing COVID-19-medical devices licensed in Canada expanding its indication for use to include COVID-19-related uses
  • existing COVID-19 medical devices that has obtained authorization from a trusted foreign regulatory authority

Expedited Review Process

  • Manufacturers are required to submit an abbreviated application to support the safety, effectiveness and quality of their medical device. 
  • The fees associated with an application are waived. 
  • Manufacturers applying through this pathway will not be required to hold a Medical Device Single Audit Programme (MDSAP) certification. 

Reporting Requirements

Manufacturers will still be required to follow strict post-market safety requirements such as mandatory problem reporting, recall procedures and complaint handling.

As with all drugs and medical devices, Health Canada will continue to assess and monitor the safety and effectiveness of all products authorized under the Interim Order, and will take immediate action if required to protect the health and safety of Canadians.

If you or your company is looking to market your COVID-19-related medical devices in Canada, now is the time act. Quality Smart Solutions has a team of experts who can provide product licensing, label compliance, and import solutions for you. Get prepared now and contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting over 500 clients worlwide for 14 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC products in Canada and the United States. Ask us for details or visit our website at www.qualitysmartsolutions.com.

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

30 Minutes Free Consultation