Health Canada’s HPFB is the national authority that regulates, evaluates and monitors the safety, efficacy, and quality of therapeutic and diagnostic products available to Canadians.Feb 12, 2015
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Does Canada require FDA approval?
Before a drug product is authorized for sale in Canada the drug manufacturer must submit scientific evidence of the product’s safety, efficacy and quality to Health Canada for review and approval. The federal review process can take between one and two years, depending on the nature of the product.
Is CFIA same as FDA?
The Canadian Food Inspection Agency (CFIA) and the U.S. Food and Drug Administration (FDA) have signed an arrangement recognizing that each of their food safety systems provides a similar level of protection.
Who approves food products in Canada?
Approving food products and processes Health Canada develops food safety and nutritional regulations, policies and guidance under the Food and Drugs Act.
Is the FDA only for the US?
In today’s world, other countries produce significant portions of the food and medical products that U.S. consumers and patients use in their daily lives. In fact, 136,400 foreign facilities in more than 150 countries export FDA-regulated products to the United States.
Does the FDA govern Canada?
Health Canada is the federal body that regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations (FDR), its related policies and guidance.
Who what agency controls the drug enforcement in Canada?
Health Canada administers the CDSA and its regulations to: allow access for lawful purposes. reduce the risk that controlled substances and precursors will be used for illegal purposes.
Who approves medical devices in Canada?
Health CanadaHealth Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada.
What is the European equivalent of the FDA?
European Medicines Agency (EMA)European Medicines Agency (EMA) : The European Medicines Agency (EMA) is a decentralised body of the European Union, located in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.
What is the FDA agreement?
The U.S. Food and Drug Administration (FDA) signed an arrangement with the Canadian Food Inspection Agency (CFIA) and the Department of Health Canada (Health Canada) recognizing each other’s food safety systems as comparable to each other. The arrangement was signed at a meeting of the FDA-CFIA Health Canada Joint Committee on Food Safety.
Why is the FDA recognizing domestic systems?
Systems recognition will help the FDA be more risk-based in planning the scope and frequency of its inspection activities , including foreign facility inspections, import field exams, and import sampling.
What is the FDA’s system recognition tool?
The FDA, working with the CFIA and Health Canada, conducted a systems recognition review and assessment using the International Comparability Assessment Tool ( ICAT). The process includes a comprehensive review of key elements of the country’s national food safety control system such as its relevant laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and laboratory support.
Is the FDA recognizing a foreign food safety system?
This is the second time that the FDA has recognized a foreign food safety system as comparable, the first being New Zealand in 2012. A similar system recognition process is underway between FDA and Australia and the European Commission. By recognizing each other’s systems, FDA, CFIA, and Health Canada, have confidence that they can leverage each …
What is the role of Health Canada?
Health Canada is responsible for establishing standards for the safety and nutritional quality of all foods sold in Canada. The department exercises this mandate under the authority of the Food and Drugs Act and pursue its regulatory mandate under the Food and Drug Regulations.
What is the role of the Canadian Food Inspection Agency?
Canadian Food Inspections Agency’s Role. All health and safety standards under the Food and Drug Regulations are enforced by the Canadian Food Inspection Agency. The Agency is also responsible for the administration of non-health and safety regulations concerning food packaging, labelling and advertising.
Which countries have comparable control measures and systems as they relate to the safety of food?
Having determined, based on the successful outcome of the food safety Systems Recognition Assessment and on existing knowledge, confidence and experience, that the United States and Canada have comparable control measures and systems as they relate to the safety of Food; and
What is the confidentiality commitment statement of legal authority and commitment from Canadian Food Inspection Agency?
The 2003 Confidentiality Commitment Statement of Legal Authority and Commitment from Canadian Food Inspection Agency Not To Publicly Disclose Non-Public Information Shared by the U. S. Food and Drug Administration (US FDA), U.S. Department of Health Human Services;
What is the confidentiality commitment statement of health Canada?
The 2003 Confidentiality Commitment Statement of Legal Authority and Commitment from Health Canada Not To Publicly Disclose Non-Public Information Shared by the U.S. Food and Drug Administration (USFDA), U.S. Department of Health and Human Services; and
How often should food safety systems be reviewed?
5.3 To support continued confidence in the countries’ food safety systems, the Participants intend to discuss Systems Recognition reassessments, reviews or audits, at least once every five years.
What is the HC in Canada?
As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for clinical trial approvals, oversight, and inspections in Canada. The G-CanadaCTApps states that the HC grants permission for clinical trials to be conducted in the country, and regulates the sale and importation of drugs for use in clinical trials in accordance with the CanadaFDR provisions.
What are the requirements for IP labeling in Canada?
Investigational product (IP) labeling in Canada must comply with the requirements set forth in the CanadaFDR, the G-CanadaCTApps, the G-GMP-Annex13, and the CA-ICH-GCPs. The CanadaFDR and the G-CanadaCTApps state that for an IP to be used in a clinical trial, it must be properly labeled in both official languages: English and French. The CanadaFDR requires that IPs be packaged and labelled under the supervision of personnel who have had satisfactory technical, academic, and other training. The packager and/or labeler must have written procedures and ensure that the IP is packaged, labelled, and tested in compliance with those procedures. For Health Canada (HC)’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.
What does HC stand for in clinical trials?
In accordance with the CanadaFDA, Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products. HC also approves the sale or importation of drugs for use in clinical trials. (See the Investigational Products topic, Manufacturing & Import subtopic for additional information on importation.) See CAN-21, CAN-23, and CAN-19, for background information on HC’s scope of assessment.
What are the ethical standards of Canada?
In accordance with the CanadaFDR, the G-TCPS2, and the CA-ICH-GCPs, Canada’s ethical standards promote respect for all human beings and safeguard the rights of research participants. The G-TCPS2 and the CA-ICH-GCPs state that a participant’s rights must also be clearly addressed in the informed consent form (ICF) and during the informed consent process. Note that per HCNotice-CA-ICH-GCPs, Health Canada (HC)-implemented International Council for Harmonisation (ICH) guidance takes precedence over other HC guidance when they are not consistent. For HC’s interpretation of the relevant provisions of the CanadaFDR, see the G-FDR-0100.
How old do you have to be to be a minor in Canada?
According to CAN-34, a minor is someone under 18 or 19 years of age, depending on the Canadian province or territory. See CAN-34 for a detailed breakdown of the legal age of majority in each province or territory.
How long to notify HC of a drug trial?
The CanadaFDR states that if a trial is prematurely terminated or suspended, the sponsor should inform HC no later than 15 days after the termination or suspension. In addition, the sponsor should provide HC with the reason (s) for the termination or suspension and its impact on the proposed or ongoing clinical trials related to the drug in Canada by the sponsor. The sponsor should also promptly notify the qualified investigators of the termination or suspension and advise them in writing of any potential risks to the participants’ health.
Can a clinical trial be conducted in emergency?
As per the CA-ICH-GCPs, in an emergency, if the signed informed consent form (ICF) has not been obtained from the research participant and/or his/her legal representative (s) or guardian (s), or, if an effective treatment is lacking but the investigational product could address the participant’s emergency needs, the clinical trial may be conducted. However, the method used on the participant must be explained clearly in the trial protocol, and the ethics committee (EC) (known as Research Ethics Board in Canada) must approve the protocol in advance. The participant and/or his/her legal representative (s) or guardian (s) should be informed about the trial as soon as possible, and consent to continue and other consent should be requested, as appropriate.
Section I Purpose and Scope
1.1 This Arrangement sets out the principles and areas of cooperation between FDA and the Canadian Participants with respect to public health and consumer protection relating to Food traded between the two countries, and to any food safety-related areas of mutual interest. 1.2 This Arrangement covers articles regulated as Food by FDA and one or bot…
Section III General Principles
3.1 Systems Recognition allows for: more efficient and effective use of resources; collaboration on risk-informed decision-making about activities that may be carried out in each country; and enhanced regulatory cooperation, improved coordination and greater reliance on the other country’s Participant(s) for follow-up and coordination when a Food Safety Concern arises. It ma…
(Video) A dose of reality about generic drugs
Section IV Intentions of The Participants
4.1 To the extent reasonably possible, FDA and the Canadian Participants intend to: 4.2 The Participants may consider broadening the scope of this Arrangement based on additional assessments at a future date.
Section V Reassessment, Review and Audit
5.1 FDA and the Canadian Participants may periodically reassess, review or audit the operation of the other country’s regulatory systems as they relate to food safety for the purpose of maintaining knowledge of and confidence in the other country’s systems. It is intended that the content and extent of any such reassessment, review or audit be based on discussions and mutually determi…
Section Vi Cooperation and Technical Information Exchange
6.1 FDA and the Canadian Participants intend to further cooperate and exchange information on at least an annual basis on regulatory and scientific issues related to food safety. Such cooperation may include, but is not limited to:
Section VII Contact Points and Notification
7.1 The Participants intend to identify Contact Points for the activities associated with this Arrangement. 7.2 Each Participant intends to provide written notification to the other Participants within 30 days of relevant changes in the names of its organization, the structure of its organization, or its Contact Points. The updating of such administrative aspects does not consti…
Section VIII Implementation
8.1 Activities under this Arrangement may be carried out through existing collaboration mechanisms or new mechanisms, as considered appropriate by the Participants. 8.2 The Participants understand that activities under this Arrangement may involve only those Canadian Participants whose involvement is appropriate given the scope of the activity. 8.3 This Arrange…
Annex – Articles Excluded from The Scope of This Arrangement
- Meat;
- Poultry;
- Processed egg products;
- Farmed catfish and catfish products;