What is a notifiable change?
Level II or Notifiable Changes (NC) are changes to a new drug that have the potential to impact the safety, efficacy, quality and/or effective use of the drug but do not require the issuance of a NOC.
What is a guidance document?
A guidance document is an agency statement of general applicability and future effect, other than a regulatory action, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation.
How long does it take for a drug to be approved in Canada?
It can take anywhere from 6 months to 2 years for Health Canada to review drug safety and efficacy information before providing a decision on whether an NOC is to be granted. Once granted, it represents that the drug meets the required standards under the Food and Drugs Act and its regulations, for use in humans.
What is a virucidal claim?
Products claiming efficacy against viruses on their label require data to support either of the following levels of efficacy: Virucide: A disinfectant represented as having efficacy against any specific virus (i.e., the product has demonstrated “virucidal” efficacy).
What is new drug submission?
An Abbreviated New Drug Submission is used to obtain approval for generic drugs. This is in contrast to a New Drug Submission (NDS), which is used to obtain approval for a new brand name drug. An ANDS lists the related drug’s brand name, chemical name, manufacturer name, dosage form(s), and strength(s).
Is guidance legally binding?
Guidance and advice is likely to be based on legislation (in which case it will be legally binding) and it might offer the best or most appropriate way to adhere to the law. The law is what you must do; the guidance might be a mixture of what you must do and what you should do.
What is the purpose of a guidance document?
Guidance documents work hand-in-hand with the applicable regulations (21 CFR 812, 312, 50, 54, 56) to deliver recommendations of leading best practices to produce clinical research in the manner that protects patient’s rights, safety, and welfare while delivering clinical data with integrity.
What is considered a drug according to Health Canada?
What is considered to be a drug? Drugs include both prescription and nonprescription pharmaceuticals; biologically-derived products such as vaccines, blood derived products, and products produced through biotechnology; tissues and organs; disinfectants; and radiopharmaceuticals.
Does Canada have a Food and Drug Administration?
Health Canada’s Role 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.
When did Health Canada Post notice of compliance change?
The first version of Health Canada’s Post-Notice of Compliance Changes – Quality Document was finalised in 2009. This document has been periodically updated and has an emphasis on applying a science-based and risk-based approach to the pharmaceutical quality assessment of these products.
What do you need to know about Health Canada quality changes?
Health Canada employees who are processing and screening submissions submitted for a quality change. 1. Introduction 2. Guidance for Implementation 3. Documentation 4. Appendices 1. Change in the name of the drug substance 2. Replacement or addition of a manufacturing site and/or manufacturer 3.
What do you need to know about post approval changes?
Review and submission of supplement/amendment for change in manufacturing site, batch size or formulation, route of synthesis, equipment, container closure system, specifications, test methods, shelf life. Preparation of a relevant Regulatory strategy for post-approval change submission
What does Health Canada mean by post NOC?
From Health Canada. The Post-NOC Changes: Quality guidance assists sponsors with the classification of quality changes made to a new drug that has received a Notice of Compliance (NOC).