News

Publications

The GMP Gazette™ May 2016

  • Final Monograph for Antiseptic Skin Cleanser
  • The Non-Prescription and Natural Health Products Directorate is moving – new physical and mailing addresses
  • Revised: Guidance Document: Preparation of Drug Regulatory Activities in the "Non-eCTD Electronic-Only" Format
  • Q9: Quality Risk M

The GMP Gazette™November 2015

  • Consultation - Prescription Drug List (PDL): Ibuprofen
  • Notice: Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format [2015-09-25]
  • Notice: Clarification of bioanalytical method validation procedures
  • Notice: Health Canada and United States Food and Drug Administr

The GMP Gazette™ September 2015

  • Consultation in the Canada Gazette: Department of the Environment and Department of Health, Proposed Regulations: Order Adding a Toxic Substance to Schedule 1 to the Canadian Environmental Protection Act, 1999, RIAS: Regulatory Impact Analysis Statement
  • Form, Revision 1.25: Changes

The GMP Gazette™ September 2014

  • Revision of Natural Health Products Compliance and Enforcement Policy (POL-0044) (NHP C&E Policy)
  • Non-prescription drug monograph attestation pilot
  • EU's DCP will be used as an information-sharing model involving non-EU or "third party" IGDRP agencies.
  • The objective of the pilot

The GMP Gazette™ August 2015

  • Notice to Stakeholders - Updates to drug establishment licence (DEL) applications and good manufacturing practice evidence requirements for active pharmaceutical ingredients
  • Revised Monograph (American ginseng)
  • Finalized Revised Labelling Standard (Topical Ana

The GMP Gazette™ July 2015

  • Revised Monograph (Traditional Chinese Medicine Ingredients) – Under Consultation
  • Revised Monograph (Homeopathy)
  • Notice (Revised): Posting information in the Drug Product Database Online
  • Revised Monograph (Hard Surface Disinfectants), Fi

The GMP Gazette™ June 2015

  • Guidance Document, Quality of Natural Health Products Guide , Version 3.1
  • Consultation – New Labelling Standard (Oral Adult Decongestant)
  • Guidance Document: Drug Submissions Relying on Third-Party Data (Literature and Market Experience)

The GMP Gazette™ June 2013

  • Information for Canadians about the Plain Language Labelling Initiative
  • Information for Industry on the Proposed Regulatory Amendment for a Fact Table
  • Health Canada 3011: Drug Submission Application Form for Human, Veterinary or Disinfectant Drugs and Clinical Trial Application/Attestation

The GMP Gazette™ May 2015

  • Inspection Tracker:  Drug Manufacturing Establishments
  • Notice: Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation Guidelines for Registration of Pharmaceuticals for Human Use
  • Notice: Posting information in the D

The GMP Gazette™ April 2015

  • Guidance Document on the Application for a Certificate of a Pharmaceutical Product (GUI-0024)
  • Consultation – New Monographs (Antioxidants and Kelp Products)
  • Traditional Chinese Medicine Ingredients (TCMI) - Under Consultation
  • Implementation of Advance Notice of Importation Process

The GMP Gazette™ March 2015

  • Notice, Re: Regulatory Decision Summaries and Submissions Under Review
  • Good Label and Package Practices Guide - Draft Guidance Document for Industry
  • Notice: Therapeutic Products with Paediatric labelling 
  • The Drug and Health Product Register
  • Draft Guidance for Industry, A

The GMP Gazette™ February 2015

Health Canada: Blood Establishment Registration and Licensing Forms and Instructions, Consultation - Revised NHP Monographs (Poria and Maitake), New NHP Monograph (Mushrooms), Consultation – Revised Hard Surface Disinfectants Monograph, Medical Devices – Single Audit Program Pilot … FDA:  S10 Photosafety Evaluation

The GMP Gazette™ January 2015

Health Canada: Internationally Harmonized Requirements for Batch Certification, Consultation - Revised Labelling Standard (Topical Anaesthetic, Analgesic, Antipruritic), Consultation – Revised Monograph (Hard Surface Disinfectants Monograph), Consultation - Revised Labelling Standard (Topical Anaesthetic, Analgesic,

The GMP Gazette™ December 2014

  • Specifies the unique facility identifier (UFI) system for the registration of domestic and foreign drug establishments
  • Addresses provisions set forth in section 510 of the FD&C Act, as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA), regarding the specification of th

The GMP Gazette™ July 2013

  • Center For Drug Evaluation and Research (CDER) Comprehensive List of Guidance Documents
  • CDER Guidance Documents: List of New/Revised/Withdrawn in 2013
  • Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products (DRAFT)
  • L
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