Axis Clinicals

🚨 Regulatory Update | CDSCO Introduces Prior Intimation System (Form CT-05) The Central Drugs Standard Control Organization (CDSCO) has implemented a Prior Intimation System for certain drug studies conducted exclusively for export purposes. This move is expected to streamline regulatory processes and improve timelines for eligible Bioavailability/Bioequivalence (BA/BE) studies. 🔑 Key Highlights: 📅 Effective Date: April 21, 2026 ⚡ Immediate Implementation: Portal submission acknowledgment will serve as the official prior intimation 🔍 Applicability & Eligibility Criteria (Form CT-05): ✔️ Study Design: Single-dose, two-period, two-sequence, two-treatment BA/BE studies in healthy adult subjects ✔️ Dosage Form: Oral drugs only ❌ Excludes cytotoxics, hormones, narcotics, psychotropics, NTI drugs, and highly variable drugs ✔️ Regulatory Status: Drug must be approved in India or major regulatory markets such as the US, EU, UK, Japan, Australia, or Canada ✔️ Sample Size: Minimum of 18 subjects 📌 Compliance Requirements: ✔️ Mandatory approval from an Ethics Committee registered with the Central Licensing Authority ✔️ Studies not meeting the above criteria will continue under the standard prior approval pathway 💡 Why This Matters: This initiative by CDSCO is a significant step toward: • Reducing approval timelines • Enhing ease of doing research for export-focused studies • Aligning with global regulatory practices 🔗 A positive shift for the clinical research ecosystem in India—especially for CROs and BA/BE centers focusing on global markets. # #ClinicalResearch #Bioequivalence #RegulatoryAffairs #PharmaIndustry #IndiaRegulations #CRO #BA_BE #DrugDevelopment