Manitoba Pharmacy Jurisprudence Practice Exam

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What is the initial step in the drug review process?

  1. Public voting on the necessity of the drug

  2. A company files a New Drug Submission to Health Canada

  3. The drug is tested in large scale human trials

  4. The drug is directly reviewed by pharmacists

The correct answer is: A company files a New Drug Submission to Health Canada

The initial step in the drug review process is always the submission of a New Drug Submission (NDS) to Health Canada. This NDS contains detailed information on the drug's ingredients, manufacturing process, clinical trial results, and proposed labeling. Option A is incorrect because public voting is not a part of the drug review process. Option C is incorrect because large scale human trials usually occur later in the drug review process. Option D is incorrect because drugs are reviewed by a team of healthcare professionals, not just pharmacists.

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