eCTD IMPLEMENTATION IN TUNISIA The electronic Common Technical Document (eCTD) system for drug submissions is being implemented by Tunisia’s National Agency for Medicines and Health Products (ANMPS). The regulatory process for pharmaceutical products will be digitized starting in January 2025 with the transition to online submissions (eSubmission).
Author: masuuglobal
Overview of MoCRA 2022: Key Provisions and FDA Cosmetic Regulations
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Regulatory update EU eCTD Validation Criteria
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Requests for Reconsideration at the Division Level Under GDUFA Guidance for Industry
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FDA Regulation of Dietary Supplements Under DSHEA
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CDSCO Revised Pharmacovigilance Guidance on Extending Event Reporting Deadline
Central drug standard control organizations has released version 2.0 pharmacovigilance guidance, enacting changes such as extending the deadline for reporting non-serious adverse events and revising record-keeping requirements.