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ICH Working on Post-Approval Safety Data Management Draft Guideline Update

Dealing with safety data overload is nothing new for biotech companies; it has been an ongoing discussion in the industry for many years now. Companies are inundated with post-approval safety information from a growing variety of sources, the quality of which is sometimes less than relevant making safety surveillance activities increasingly difficult.

The ICH E2D (R1) group is dealing with the ambitious task of updating the ICH E2D guideline on the management of post-approval safety data, which has been in place since 2003. Several challenges complicate this update, including the lack of harmonized regulatory requirements across ICH member regions, the need for consistency with other pertinent documents, and the sometimes poor understanding among different regulatory authorities of the various projects companies put in place to receive feedback (including patients’ safety-related feedback) on their approved products: patient support programs, drug delivery/continuity programs, and so-called “social media listening” and “sentiment analysis” programs.

A draft version of the revised guideline is anticipated for consultation by Q4, 2022: https://database.ich.org/sites/default/files/E2D-R1_ConceptPaper_Final_2020_0115.pdf.

The staff at Med Communications strives to stay abreast of all the latest guidelines updates to help our clients stay in compliance. To learn more about how our team can help you manage your safety data, please contact us: 877-477-0977 or https://medcommunications.com/about-us/contact-us/.

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