What is the primary statutory body responsible for regulating and inspecting pharmaceutical products and medical devices in Egypt?

Answer and explanation

Correct answer: D. Egyptian Drug Authority (EDA)

  1. Step 1: Established by Law 151 of 2019, the EDA is the national regulatory authority for human and veterinary medicines, cosmetics, and medical supplies.
  2. Step 2: It oversees clinical trials, drug registration, manufacturing compliance, and pharmacovigilance.
Answer
Egyptian Drug Authority (EDA).
Why not the others: 'Ministry of Higher Education' oversees universities; 'General Authority for Healthcare' manages hospitals under Universal Health Insurance; 'Food Safety Authority' regulates foodstuffs.

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