Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory enrolment process. The REP is a regulatory enrollment process for medicinal products. It is an essential step in the pathway to market approval.
A drug company must apply to Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD) for authorization of its product before it can be sold in Canada. The NNHPD reviews the application and, if it determines that the product meets safety, efficacy, and quality standards, will issue a Notice of Compliance (NOC) authorizing sale in Canada. This blog will outline the top things you need to know about Health Canada’s regulatory enrollment process.
What Does It Do?
First and foremost, we should know about Regulatory Enrolment Process. It is a set of web-based templates that are used to collect information from the industry related to:
- The Company
- Product and dossier
- Regulatory Activities
- Regulatory transactions
This program captures information in a structured form. REP templates have replaced the previous processes, which were processing Health Canada forms and Human drug submission application fee forms. This program utilizes extensible markup language (XML) format. Use of the REP has been made mandatory since October 1, 2020, by the Government of Canada.
1. Purpose of REP
REP has been designed to modernize how regulatory information is shared with Health Canada. The primary purpose of using this program is to implement a common approach for all product lines, which includes the following:
- To send all the regulatory transactions by using a single process. By using this process, the other ways like media (CDs, DVDs, etc.) got, and email transmission of submission to The Health Products and Food Branch (HPFB) gets eliminated. It expands the scope of the standard electronic submissions gateway (CESG) to allow regulatory transactions in The Electronic Common Technical Document (eCTD).
- Since that REP files will be sent in the form of the XML format by the sponsors, it will ensure the information’s accuracy, consistency, and reliability. And data will be uploaded to the internal Health Canada System.
- The web-based REP templates are designed to support more accessible and faster data entry for sponsors with the help of drop-down lists, predictive text, help text, etc.
- HPFB will collect routing IDs using the REP template to secure two-way communication between Health Canada and sponsors. By this, sponsors send all regulatory transactions to Health Canada and receive correspondence from them using CESG.
2. Scope of Mandatory REP
Mandatory filing of regulatory transactions using REP will apply to pharmaceutical, biological, and radiopharmaceutical drugs for human use and disinfectants, which is being implemented from Oct 2020. It is voluntary for veterinary medications and has been implemented since October 1, 2022.
3. Acceptable and Unacceptable Regulatory Activities
The regulatory authority provides segregated lists of acceptable and unacceptable regulatory activities to assist medical device manufacturers in better comprehending the prospects of their application requests. Details of the Class wise type of applications/ amendments concerning said activities are highlighted in the ensuing paragraphs:
Scenarios wherein Regulatory Enrollment Process could be applied:
- Class II, III, and IV license applications
- Class II, III, and IV license amendments
- Class II, III, IV minor change amendments
- Class II, III, IV Private Label applications
- Class II, III, IV Private Label amendments
Scenarios/ Applications wherein Regulatory Enrollment Process could not be applied:
- Investigational Testing Application
- Medical Device Establishment License (MDEL) Applications (such as Class I medical devices)
- Special Access Program (SAP) Applications
4. Process for Participation in the Regulatory Enrollment Program
To begin participating in the Regulatory Enrollment Program, a comprehensive procedure has been laid out to provide requisite guidance for the manufacturers. Details of the said procedure are highlighted in the following points. Health Canada also encourages submitting the proper requests within a short period.
Submission of Application
To submit the appropriate request, the platform used shall be through email.
- The name of the medical device which the manufacturer is applying for participation
- Contact details
- The number of existing dossiers and the ones the manufacturer intends to submit.
Dossier ID Process
The Dossier ID Request Form is the only method for requesting REP and eCTD dossiers from Health Canada. A maximum of eight weeks’ time cushion be considered before filing the regulatory transaction.
While it is essential to highlight that REP is imperative for Human Drugs and Disinfectants, it is optional (voluntary) for Drugs to be administered to animals (Veterinary Drugs). In either case, the fees are an essential consideration during the procedure for REP.
To ensure the human safety and wellbeing of the users/ patients (human and animals), Health Canada reviews the drug’s efficacy in the intended species to ensure its effectiveness before its use. Fees are further categorized into Fees for Human Drugs and Fees for Veterinary Drugs.
Fees for Human Drugs
In the case of Fees for Human Drugs, comprehensive guidelines are available on the official website, wherein all the essential information related to the regulatory activities concerning Human Drugs (including both pharmaceutical and biological drugs) are stated.
Fees for Veterinary Drugs
To further strengthen the compliance and enforcement programs so that all manufacturers conform to the desired standards, additional fees will be charged, such as Fees for examination of an application for an establishment license, Fees for the right to sell drugs, and Master file fees. These fees are standard for both Drug Categories (Human Drugs and Veterinary Drugs)
The Bottom Line
The abovementioned procedures and guidelines are meant only to state a streamlined process for Canadian health regulatory enrollment for drugs as per the publicly available guidelines. However, these guidelines are subject to change per the country’s latest rules, regulations, and amendments (if any). All the latest policy changes or updates to existing laws, rules, and procedures in vogue are generally reflected on the official website of the Government of Canada (official weblink: Home – Canada.ca).