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Romania updates its regulatory legislation to align with the EU regulations
On July 20, 2022, Law 249/2022 entered into force stipulating a mandatory 60-day approval by the ANMDMR (National Agency for Medicines and Medical Devices in Romania) for a new clinical trial application. The introduction of this law is an essential step for the Romanian regulatory agency to align its practices with the “Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC”.
Accell’s team has broken down the main statements of the update in accordance with the text of the initial legislation and explained how such changes would influence the regulatory landscape within the field of clinical research in Romania. The article is available by following this link.
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