Health Canada

In order to facilitate the implementation of the E3 Guideline, the International Conference on Harmonisation (ICH) Experts have developed a series of Questions and Answers.

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E5 Q&A(R1).

Q&A Regarding the Adoption of Periodic Benefit Risk Evaluation Report.

Guidance on the regulatory requirements for prescription labelling of opioid drugs.

Health Canada's approach to the registration and disclosure of Canadian clinical trial information

Regulatory Decision Summaries (RDSs) explain Health Canada's decision for certain health products seeking market authorization.

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to: company, dossier and product, regulatory activity, and regulatory transaction. REP consists of web-based templates that capture information in a structured format.

This notice applies to energy-based medical devices for therapeutic or cosmetic indications intended for sale in Canada.

This guidance document explains the regulatory information requirements and conditions for practitioners and manufacturers when drugs are requested through the Special Access Program (SAP). It explains SAP's mandate, intent and scope, and outlines the responsibilities of practitioners and...

The Special Access Programme (SAP) allows practitioners to request access to drugs that are unavailable for sale in Canada. This access is limited to patients with serious or life-threatening conditions on a compassionate or emergency basis when conventional therapies have failed, are unsuitable,...

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances

E9: Statistical Principles of Clinical Trials. This guidance has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.

The objective of this guidance document is to allow the compilation of a single core clinical study report acceptable to all regulatory authorities of the ICH regions. The regulatory authority specific additions will consist of modules to be considered as appendices, available upon request...

This guidance document is intended to aid manufacturers and regulatory representatives in preparing medical device licence applications for dermal fillers.

In recent years, there has been a dramatic increase in the level of interconnectedness and data exchange between medical devices and their network environments. Increased connectivity in medical devices can: improve access to health care information; facilitate more timely diagnoses and...

As a regulator, Health Canada plays an important role in protecting the health and safety of Canadians. Health Canada is committed to being transparent and open about its activities and to making timely and useful information available about health products and health product submissions. Greater...

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (i.e., new drug and abbreviated new drug submissions), of proposed modifications to Health Canada’s comparative bioavailability requirements when multiphasic plasma concentration...

This guidance document clarifies the application of the risk classification rules for IVDDs set out in Part II of Schedule I of the Medical Devices Regulations, and was recently rewritten to include updated examples and to conform to Good Guidance Practices.

The Food Source Contribution Table (FSCT) provides estimates of how much various food groups and subgroups contribute to Canadians’ intakes of energy and selected nutrients using data collected in the 2015 Canadian Community Health Survey (CCHS) - Nutrition. Two different datasets are available....

This guidance document addresses the development of contraceptive products, intended for use by women during their reproductive years, which contain sex steroids as active ingredient(s).