Alexander Gaffney from raps.org has just released an article on regulators releasing the latest guideline on electronically transmitting individual case safety reports (ICSR) from the International Conference on Harmonisation’s (ICH). ICH is a pharmaceutical harmonization group that is run by US FDA, European Medicine Agency (EMA), and Japan’s Ministry of Health, Labor and Welfare (MHLW). ICH aims to have regulatory processes better align with different administrations allowing for greater efficiency between industry and regulators. The final guideline, E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification, provides an outline for the data, terminology, and exchange standards for ICSR submissions to improve the quality of data and improve the analysis of the documents. To read the full article click here.
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