The journey of a drug from discovery to patients follows a structured regulatory pathway worldwide, with region-specific authorities ensuring safety, efficacy, and quality.
🔬 𝐃𝐢𝐬𝐜𝐨𝐯𝐞𝐫𝐲 & 𝐏𝐫𝐞-𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐒𝐭𝐮𝐝𝐢𝐞𝐬
Identification of drug candidates and non-clinical safety evaluation.
👩⚕️ 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 (Phase I–III)
Assessment of safety, efficacy, dosage, and risk–benefit profile in humans.
📄 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧𝐬
🇺🇸 USA: IND → NDA to FDA
🇮🇳 India: CT-04 → NDA (CT-21) to CDSCO
🇪🇺 Europe: MAA to EMA
🇬🇧 UK: MAA to MHRA
✅ 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐑𝐞𝐯𝐢𝐞𝐰 & 𝐀𝐩𝐩𝐫𝐨𝐯𝐚𝐥
Scientific review by respective authorities before market authorization.
🛡️ 𝐏𝐨𝐬𝐭-𝐌𝐚𝐫𝐤𝐞𝐭𝐢𝐧𝐠 𝐒𝐮𝐫𝐯𝐞𝐢𝐥𝐥𝐚𝐧𝐜𝐞 (𝐏𝐡𝐚𝐬𝐞𝐈𝐕)
Continuous monitoring to ensure long-term safety in real-world use.
📌 Though processes differ regionally, the goal remains the same: patient safety and effective therapies.
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