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EMA’s New CTIS Safety Module for Annual Safety Reports: Sponsor and Member State Guidance
The European Medicines Agency (EMA) has published two complementary guidance documents explaining the new CTIS Safety Module for Annual Safety Reports (ASRs). Together, they describe the end-to-end process for ASR submission, assessment, safety issue management and finalisation. Sponsor Guidance: New Safety Module on the Annual Safety Report The Sponsor Guidance explains how sponsors will prepare, submit and manage Annual Safety Reports through the new Safety Module. Transiti
Sharan Murugan
Sep 263 min read
UK MHRA Guidances: 9 important Guidances on Clinical Trials Safety, Approvals, Labelling, and More
Clinical trials are the cornerstone of modern medicine, ensuring that new treatments are safe, effective, and suitable for public use....
Sharan Murugan
Jun 28, 20253 min read
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
Sharan Murugan
Apr 29, 20232 min read