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Guidance for Industry - Priority Review of Drug Submissions (PDF Version - 67 K) Contact: Bureau of Policy Science and International Programs Notice February 6, 2009 Our file number: 09-101263-867 Administrative Corrections to Health Canada's Priority Review Documents…

Submitting risk management plans guidance document: Overview Overview When to provide an RMP Preparing and submitting an RMP RMP note to reviewer template Canadian-specific addendum template RMP summary template Definitions Resources Contact us Access the Risk management plan…

Quality Overall Summary - Chemical Entities (New Drug Submissions/Abbreviated New Drug Submissions) (QOS-CE (NDS/ANDS)) (PDF Version - 48 K) (Microsoft Word Version - 126 K) (Wordperfect Version - 123 K) Contact: Bureau of Pharmaceutical Sciences Date: 2004-04-01 Page details…

Clinical Trial Application - Amendments (CTA-As) CTA-A s are applications in which a sponsor proposes information to support changes to a previously authorized application [ C.05.008 ]. Where a sponsor wishes to make changes to a CTA under review, the sponsor should withdraw the…

Filing of clinical trials Frequently Asked Questions Filing of Clinical Trials My company currently has an ongoing IND in the USA, and would like to expand to include Canadian investigators. How is this done? My trial was filed as an Investigational New Drug Submission (INDS)…

Clinical Trials - Canada.ca

Health CanadaCaptures 11Dernière capture 11 avr. 2026en

Clinical Trials COVID-19 Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors [2020-03-23] Applications for COVID-19 drug and medical device clinical trials under the Interim Order: Notice release of guidance documents [2020-05-27]…

Yearly Biologic Product Reports: Questions and Answers (PDF Version - 34 K) What is the Yearly Biologic Product Report (YBPR)? What is the purpose of the YBPR and how is the information in the YBPR useful to Health Canada? What information should be included in the YBPR? What are…

Guidance - Use of Positron-emitting Radiopharmaceuticals in Basic Clinical Research Foreword Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance documents also provide…

ARCHIVED - Regulatory Issues Associated with the Development and Licensing of SARS Vaccines and Immunotherapy Products We have archived this page and will not be updating it. You can use it for research or reference. We have archived this page and will not be updating it. You can…

Health Canada Scientific/Expert Advisory Panels Health Canada uses ad hoc scientific/expert advisory panels to provide medical/technical/scientific advice and recommendations on issues related to biologics and radiopharmaceuticals. Members are appointed by Health Canada. Page…

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