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Canada Drug Product Registration

Safeguarding Public Health Through Comprehensive Regulation

MoH: Ministry of Health Canada/ Health Canada

MoH website: https://www.canada.ca/en/health-canada.html

Regulatory Authority: Health Canada/ Therapeutic product Directorate

Link for Regulatory Authority: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products.html

Local Authorised: No

Registration Fee: 2023-2024 565,465 CAD $

Regulations: Food and Drug Regulation (FDR)

Regulatory requirement:

Submissions must be provided to Health Canada in an electronic Common Technical Document (eCTD) format.

  • Module 1: Administrative Information and Prescribing Information
  • Module 2: CTD Summaries
  • Module 3: Quality
  • Module 4: Non-Clinical Study Reports for New Chemical Entities
  • Module 5: Clinical Study Reports

Abbreviated New Drug Submission (ANDS)

  • The purpose of the ANDS rule is to streamline and reduce the cost of the approval procedure for generic pharmaceuticals.
  • Under an ANDS, a drug manufacturer must prove that its product is pharmaceutically equivalent and/or bioequivalent with the medication developed by innovator’s drug.
  • A physico-chemical comparison or a bioequivalence study (parenteral medications or pharmaceuticals for which it is unethical to conduct the research on healthy volunteer) may be required by the sponsor in order to qualify an ANDS.

New Drug submission Process in Canada

The drug approval pathways in Canada are as follows:

1.    Regular New Drug Submission Process in Canada – NDS

  • NDS is the regulatory process required by Health Canada that pharmaceutical companies are required to go through to bring their new drugs into the market.
  • All relevant information on the medication, including non-clinical, clinical, and quality data that addresses its safety and efficacy and overall quality (chemistry, manufacturing, and controls), must be included in the submission.
  • After reviewing this data, Health Canada decides if the medication is safe, effective (positive benefit vs. risk ratio), and of excellent quality for the intended purpose. It can only then be authorized for public sale.
  • The standard duration for the scientific assessment of the NDS is 300 days, comprising a preliminary screening phase lasting 45 days and an additional 10 days dedicated to technical processing.
  1. Priority Review New Drug Submission Process in Canada – PR NDS
  • When a new drug reaches the end of its clinical development program and is thought to have the potential to significantly outperform existing therapies (when available) for serious or life-threatening conditions, it is submitted to Health Canada as a Priority Review (PR) New Drug Submission (NDS).
  • PR NDSs are prioritized over standard NDSs and are scientifically reviewed within 180 days, rather than the standard review time of 300 days.
  • The goal of this accelerated review procedure is to enable people in need to receive new, cutting-edge medicines faster.
  • Rather than going through the normal NDS procedure, the sponsor must seek a PR through a formal request accompanied by a Clinical Assessment Package, providing adequate evidence and a scientific justification for why the submission should be given PR.
  1. Notice of Compliance with Conditions – NOC/c NDS:
  • It allows a sponsor to bring a new drug into market during the clinical development process, and therefore more quickly, in exchange for accepting to complete the clinical development program agreed upon with Health Canada.
  • After a medicine is approved, a sponsor must abide by the terms of approval under the NOC/c policy.
  • When there are encouraging indications of clinical benefit based on the available data, NDSs and SNDSs for serious, life-threatening, or severely disabling illnesses are eligible for advanced consideration for a NOC/c.

 

  1. Drug Submissions Relying on Third-Party Data (Literature and Market Experience)
  • This is the process of proving a drug’s safety and effectiveness without using clinical research findings, by using existing scientific literature or data provided by third parties. In Canada, a Supplemental New Drug Submission (SNDS) or a New Drug Submission (NDS) may be supported by literature.
  • If the submission meets HC’s requirements, this method saves time and money for the sponsor and HC. To support the safety and effectiveness of the medicine under consideration and to comply with the most recent rules, guidelines, and recommendations, the literature must be pertinent, trustworthy, and sufficient. The same as for any other NDS or SNDS, the criteria for chemical, manufacturing, and controls (quality) data apply.
  • In addition to the channels outlined above, HC investigates other avenues to support drug development to solve unmet medical requirements and optimize internal procedures. Some of these avenues include: The Australia-Canada-Singapore-Switzerland (ACSS) Consortium involves the utilization of overseas evaluations and rulings.
  1. After the Notice of Compliance – NOC
  • After reviewing the submission, Health will issue a Notice of Compliance (NOC), allowing the sponsor to market the medicine in Canada, provided the drug is safe and effective for its population.

Summary of Canadian Drug Review Process

  1. The sponsor must test the new drug for toxicity on animals. To get fundamental data on the safety and effectiveness of the substance under investigation, a variety of species are employed.
  2. The sponsor may file a Clinical Trial Application to the Canada’s Health Products and Food Branch (HPFB), asking for permission to carry out a clinical trial in Canada, if these preclinical testing show that the drug has the intended effect and is not hazardous. A clinical trial’s objective is to collect data on a medication’s dosage, efficacy, and safety in humans.
  3. The Clinical Trial Application, which contains details about the dosage form, production procedures, preclinical test findings, and the investigators carrying out the research, is reviewed by the HPFB.
  4. A clinical study is conducted with informed and consenting human participants in a controlled setting under strict supervision of drug administration and results evaluation methods, provided the HPFB grants the sponsor permission to move forward with the experiment.
  5. The sponsor may decide to submit a New Drug Submission (NDS) to the HPFB if the clinical trial findings show that the drug’s potential therapeutic benefit overcomes the risks (e.g., toxicity, undesirable side effects). The NDS is required to include information and statistics addressing the safety of the medicine, such as the outcomes of preclinical and clinical studies, manufacturing details, packaging and labeling information, and details about the drug’s adverse effects and therapeutic claims.
  6. To determine the potential benefits and risk of the medication, the HPFB thoroughly reviews the material provided, sometimes consulting with outside experts and advisory groups. It then assesses the safety, effectiveness, and quality data. It also examines the medication information that the sponsor suggests giving to consumers and healthcare professionals.
  7. After reviewing the information, the HPFB issues a Notice of Compliance (NOC) and a medicine Identification Number (DIN) to formally authorize the medicine for sale in Canada if it determines that the benefits of the medication exceed the risks and that the risks can be managed. Note: All medications approved for sale in Canada must pass inspection to guarantee they adhere to Food and Drugs Act regulations.

 The medicine’s sponsor may choose to offer more information, resubmit the application later with further supporting material, or request that the HPFB review its decision if the agency decides not to approve the drug for marketing.

  1. After a product is authorized, Health Canada may use its Lot Release Process to test it further and keep an eye on its quality, safety, and efficacy.