The GMP Gazette™ December 2017

  • Notice: Medical Device Single Audit Program (MDSAP) Reduction of Audit Times
  • Notice: Publication of the Guidance Document: Guidance for Manufacturers of Human Immunodeficiency Virus (HIV) Rapid Diagnostic Tests (RDTs) for use at the Point of Care or for Self-Testing
  • Guidance: General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products
  • Guidance: Recommended Statement for Over the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery
  • Guidance Document: Addendum - Quality (Chemistry and Manufacturing) Guidance: Questions and Answers
  • Updated Notice: Interim Policy on Health Canada's Interpretation of Medicinal Ingredient and Assessment of Identical Medicinal Ingredient
  • Notice: Validation rules for regulatory transactions submitted to Health Canada in the electronic Common Technical Document (eCTD) format
  • Notice: General Chapters <232> Elemental Impurities–Limits and <2232> Elemental Contaminants in Dietary Supplements Applicable as of January 1, 2018
  • Consultation on the Proposed Approach to the Regulation of Cannabis
  • Proposed Approach to the Regulation of Cannabis

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