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April 2024

Safety Observer 210

The FDA has announced that it is now accepting the submission of premarket ICSRs in the E2B(R3) format.

Released 08-Apr-2024
Pages 48
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Report 210 — Highlights

CIOMS MLGs

CIOMS has published a new report, which is intended to address the need for a harmonized approach to the creation and use of MedDRA Labeling Groupings (MLGs) in product information.

FDA & E2B(R3)

Further to its January announcement regarding postmarketing ICSRs, the FDA has now announced that it is also accepting the submission of premarket ICSRs in the E2B(R3) format.

New Zealand

Medsafe has published a revised version of its Pharmacovigilance Guideline, which describes the Pharmacovigilance obligations of Pharma companies in New Zealand.

Singapore

The Health Sciences Authority (HSA) in Singapore has published a revised guideline on Post-Marketing Vigilance Requirements for Therapeutic Products.

Literature ICSRs & Day 0

The EMA has published a revised version of its guidance on the interpretation of the requirements regarding Day 0 for ICSRs described in local journals.

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