Medicine - Definitions, History, and Regulation

Exam-Oriented Revision Sheet

1. 📌 Essentials

• Medicine: Substance with curative or preventive properties.
• Phology: Study of drugs' discovery, effects, and use.
• Pharmacopée: Official reference book defining raw material standards.
• Key historical milestones: Sumér tablets, Egyptian papyrus, Hippocrates, quinine, penicillin, chlorpromazine.
• Drug development phases: Preclinical (safety), clinical (efficacy), post-marketing surveillance.
• Regulatory bodies: ANSM (France), EMA (Europe); approval via AMM valid 5 years.
• Classification systems: ATC hierarchical system; forms include tablets, solutions, creams, injections.
• Sources of drugs: Natural (plants, animals, minerals), synthetic, biotechnological.
• Discovery methods: Observation, chance, error, rational design.
• Evidence levels: Meta-analyses, large RCTs (high); case series (low).
• Pharmacovigilance: Ongoing safety monitoring post-approval.

2. 🧩 Key Structures & Components