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Romania harmonizes regulatory approval procedures to secure clinical trials start-up timelines in accordance with the EU Regulation

Embrace the potential of Romania as an attractive destination for your next clinical trial thanks to the legislation update guaranteeing a 60-day approval by the Romanian regulatory authority. The regulatory approval has become transparent and predictable to favor study start-up timelines.

In Romania, on July 20, 2022, the 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. 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”.

 

Key takeaways of the updated regulatory legislation in Romania are the following:

1.The Romanian Regulatory Agency has a maximum of 30 days to either validate or invalidate the authorization request of a submitted study.

2.If the ANMDMR has not notified the Sponsor of any objections within those 30 days, it signifies that the Agency may not further invalidate the request. Therefore, under a condition that the Sponsor has received an approval by the National Bioethics Commission for Medicines and Medical Devices (CNBMDM), which takes 60 days, they can start the clinical trial; the Sponsor will need to notify the Romanian Regulatory Authority about the trial start-up within a maximum of 5 days.

3.If the Romanian Regulatory Authority informs the Sponsor of its objections, the Sponsor has 15 days from the date of receipt of those objections to provide a modified application.

4.Within a maximum of 60 days from the initial submission date, the Romanian Regulatory Agency notifies about either the authorization of the submission (if the objections have been amended or if there were no objections) or a refusal of the trial (if the objections have not been amended satisfactorily).

Therefore, the update in the legislation turns Romania into a territory with a predictable regulatory landscape that guarantees a clinical trial approval within 60 days. This is a huge step for the country to render it more attractive in terms of the clinical research in Europe given its updated regulatory process and timelines, a solid population of almost 19 million people and centralized healthcare system that creates a funnel of patient flow and, thus, enables predictable recruitment, along with a pool of experienced, educated and trained medical professionals to carry out innovative treatment research.

 

Accell opens an office in Romania to enhance its clinical research capabilities in Europe

Since Romania is turning into a potent and desired clinical trial destination, Accell Clinical Research has decided to enhance its presence in the country by opening an office in Bucharest, the capital of the country, in July 2022. The head of the Romanian and European clinical operations has become Accell’s long-term partner, Daniela Pirvu, MD, with 17+ years of experience in the field of clinical research throughout the entire cycle of clinical studies in phases I, II, III, and IV, bioequivalence, biosimilars, and medical devices and a vast expertise in a wide range of therapeutic areas along with an in-depth knowledge of the European regulatory environment. Thanks to the new partnership, existing project management practices, and the establishment of Accell’s presence within the European Union, the company has extended its geographical capabilities and includes such countries as Romania, Bulgaria, Hungary, Slovakia, Serbia, Czechia, Poland, Ukraine, Latvia, Lithuania, Albania, Greece, France, Germany, Spain, Ireland, and the UK.

Accell’s Romanian office address is Banul Antonache Street, No. 40-44, District 1, Bucharest, Romania.

To learn more about Accell’s present capabilities and discuss your clinical trial needs, please feel free to get in touch with us at bd@accellclinical.com. We will be happy to cater to you the best clinical trial experience while making sure our Sponsor meets all their study objectives.

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