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Consultation on the Draft Guidance Document: Administrative Processing of Drug Submissions and Applications Involving Human or Disinfectant Drugs
Food and drug | Health
Feb 17, 2017 - Apr 18, 2017
It is proposed that this draft guidance document will replace the 1998 policy, Change in Manufacturer's / Product Name Policy (CMPN), which governs the administrative processing of drug submissions and applications. The proposed new guidance document clarifies the requirements for eligible drug submissions and applications under the administrative pathway.
Feb 7, 2017 - Mar 8, 2017
An Act respecting a Federal Framework on Lyme Disease (Act) came into force on December 16, 2014. The Act commits the Minister of Health to convene a conference to develop a federal framework on Lyme disease with: patients' groups, the medical community and provincial/territorial health ministers. The Conference took place in May 2016 and as a result the framework was drafted. Before finalizing it, we invite Canadians to submit comments on the draft.
Release of International Council on Harmonisation (ICH) Document: Good Clinical Practice (GCP) "Renovation" Reflection Paper
Food and drug
Feb 2, 2017 - Mar 11, 2017
The above referenced draft document was released by the ICH Management Committee for consultation and is being posted on the ICH website for information and comment in accordance with the ICH process.
Food and drug
Feb 1, 2017 - Apr 17, 2017
The purpose of this Notice of Consultation is to provide an opportunity to comment on the proposal to add hydroquinone to the Prescription Drug List (PDL) when sold in a concentration greater than 2% in topical products. Only the Human part of the PDL is proposed to be revised.
Consultation on the Health Canada Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions
Food and drug
Jan 31, 2017 - May 1, 2017
The Draft Guidance Document: Use of Certificates of Suitability as supporting information in Drug Submissions outlines policy and guidance for industry and staff regarding the submission of information for marketing authorisation of new drugs pursuant to the Food and Drugs Act and Food and Drug Regulations. The purpose of the guidance document is to outline the requirements when preparing submissions that rely on Certificates of Suitability (CEPs) issued by the European Directorate for the Quality of Medicines and Healthcare (EDQM) to support the safety and effectiveness of a drug. It can also be used as guidance on the requirements for related drug submissions (for example, SNDSs, SANDSs, Post-NOC Changes).
Animals | Exporting/Importing | Food and drug | Plants
Jan 26, 2017 - Mar 31, 2017
The Canadian Food Inspection Agency is proposing to streamline and update its cost recovery program. Our objectives are to support regulated parties in the food, plant and animal sector with greater consistency in fees, increased efficiencies and improve predictability in service delivery while aligning fees to better reflect the current costs of delivering service.
Food and drug | Health | Regulations
Jan 21, 2017 - Apr 21, 2017
Canadians and food businesses play an important role in protecting Canada's food supply. The proposed Safe Food for Canadians Regulations (SFCR) introduce modern food safety requirements for businesses that import food, or prepare food to be exported or sold across provinces. Find out how these regulations would strengthen Canada's food safety system and safeguard the health of Canadians, your families and your business.
Consultation on the Technical and Policy Framework for Radio Local Area Network Devices Operating in the Band 5150-5250 MHz
Communication | Regulations
Jan 19, 2017 - Mar 29, 2017
Through the release of this document, Innovation, Science and Economic Development Canada is hereby initiating a consultation on whether to modify the current technical and policy framework for radio local area network (RLAN) devices operating in the 5150-5250 MHz frequency band.
Environment | Natural resources | Public safety | Regulations
Jan 11, 2017 - Mar 13, 2017
Public consultation on the NEB's intent to increase the level of company emergency response detail at the application phase of a pipeline project.
Jan 11, 2017 - Mar 15, 2017
The Federal-Provincial-Territorial Committee on Drinking Water (CDW) has assessed the available information on lead with the intent of updating the drinking water guideline. The purpose of this consultation is to solicit comments on the proposed guideline, on the approach used for its development and on the potential economic costs of implementing it, as well as to determine the availability of additional exposure data.
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