SQA Regulatory Surveillance Summary 4 | Monthly Update 2021
SQA
JUNE 10, 2021
The new regulation, RDC 478/2021 , repeals economic monitoring and reporting processes previously established under RDC 185/2006, and initially reduces the number of medical device types for which economic monitoring will be required. Guidance on the Licensing of Biosimilar Products, 06 May 2021. National Research Council.
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