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We invite you to follow our subject matter experts as they share useful information about key industry regulations along with insights about how organizations are improving the efficiency of regulatory operations information management.
New EMA’s Union Product Database production release
The EMA released version 01.02 of the Union Product Database on 16th March 2021. As part of the New Veterinary Regulations (NVR) implementation, the EMA is developing a Union Product Database (UPD) to allow the management of veterinary medicinal products in the EU. The UPD has been welcomed by many and will certainly improve the …
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EMA’s Union Product Database user research
Union Product Database: EMA’s Veterinary Medicines Division released user research. In January 2021, the EMA released some interesting findings about how stakeholders might want to make use of the Union Product Database (UPD). What is the UPD? According to the New Veterinary Regulations (NVR) EU 2019/6, the European Medicines Agency (EMA) shall establish and maintain …
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FDA’s eCTD end of life?
Action required: The FDA withdraws support for eCTD Module 1 US Regional DTD 2.01. FDA’s eCTD end of life? Not quite, but it looks like we are getting there. In October last year, the FDA announced the end of support for eCTD Module 1 US Regional DTD 2.01 for marketing applications. By 1st March 2022, …
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