New discussion: PhV in medical research - XXXIII

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Dear members,The current situation for periodic safety reports on marketed drugs is different among the regions.A. US regulations - Quarterly reports during the first 3 years, then annual reports. B. EU Regulations - 6 months for two years, annually for the three following years and then every five yearsC.

Japan - survey on a cohort of a few thousand patients established by a certain number of identified institutions during the 6 years following authorization. - Systematic information on this cohort, taking into account a precise denominator, must be reported annually. - Non-serious Adverse reactions mild in severity and unlabeled must be reported every 6 months for 3 years and annually thereafter.D. India - Every 6 monthly for the first 2 years of marketing in India, and annually for the subsequent 2 yearsRegards,Dr. Vijay M. katekhayePostgraduate StudentDept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060----- Forwarded Message ----From: Dr. vijay Katekhaye <dr.vijaykatekhaye@...>netrum Sent: Sat, 30 October, 2010 6:51:11 PMSubject: New discussion: PhV in medical research -

XXXI

Dear members,Lets move to another interesting topic - PSURPSUR stands for the Periodic Safety Update Report, generally done for the marketed products, and is a part reporting the clinical safety information on continual basis.The PSUR have some regulatory requirements and they are not same across the world.(USA, EU and Japan)Regards,Dr. Vijay M. KatekhayePostgraduate Student (JR II)Dept. of Pharmacology,LTMMC & LTMGH, Sion,Mumbai - 400 022 Ph - +919619313060