Retention period and quantity for Malaysian submission [Regulatives / Guidelines]

posted by cakhatri – India, 2020-08-10 06:04 (272 d 01:58 ago) – Posting: # 21848
Views: 1,022

Dear Sriram,

Malaysia has adopted BE guidelines from EMA. Hence you can follow EU guidelines for retention quantity

You can refer section 4.1

The calculation of samples required for retention quantity shall be provided by the sponsor and retained by the site


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