REGULATORY UPDATE ROMANIA - NEW LAW IMPLEMENTING A 30-DAY SILENT APPROVAL FOR CLINICAL TRIALS

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REGULATORY UPDATE ROMANIA - NEW LAW IMPLEMENTING A 30-DAY SILENT APPROVAL FOR CLINICAL TRIALS

On 20th July 2022, the Romanian President signed the Law that establishes the implementation of a 30-day silent approval deadline for each clinical trial submitted to the regulatory authority, Romanian Drug Agency (ANMDMR) under Directive 2001/20/CE.

Through this new normative act, Romania is speeding up the regulatory approval process for clinical trials. Among the most important changes of the Law, we mention the following:

  • to ensure the adequate protection of patients' right to live, applications for authorization of a clinical trial or evaluation of amendments to the clinical trial submitted to ANMDMR are validated/invalidated by ANMDMR within a maximum period of 30 days from the submission date of the authorization application.
  • in case ANMDMR has not notified the sponsor of any reasoned objection within 30 days, the ANMDMR is considered to have no objections and the clinical trial may begin if a favorable opinion has been issued previously by the National Bioethics Committee of Medicines and Medical Devices (CNBMDM).
  • in case of objections raised by ANMDMR, the sponsor sends ANMDMR the request modified according to their objections within a max. 15 days after receiving the objections. Within a max. of 60 days from the submission date of the application (+ max. 15 days for the sponsor’s response time), ANMDMR notifies the sponsor either of the authorization of the clinical trial (respectively the authorization of the amendment to the clinical trial) or of the rejection of the trial if the objections by ANMDMR have not been answered satisfactorily.

It is important to underline that no changes have been made with regard to the content of the submission package under Directive 2001/20/CE. The changes only address approval timelines, namely the implementation of a 30-day silent approval deadline.

The new law also stipulates the local legislative framework for transposing Regulation EU 536/2014 set to replace the Clinical Trials Directive, which will become mandatory as of January 31st, 2023. 

Until the 30th of January 2023, the Sponsors have the option to submit clinical trials in Romania either under Directive 2001/20/CE (30-day silent approval) OR under the new Regulation EU No 536/2014 (60-day approval using the EU Portal). 

As of 31st of January 2023, the Sponsors can submit clinical trials in Romania (similar to all other EU countries), ONLY via Regulation EU No 536/2014.

Thanks to this new law Romania is positioned as a competitive location for clinical trials, offering its immense potential of highly trained medical professionals, centralized healthcare infrastructure, and, most importantly, its large pool of patients eager to join international clinical trials with innovative treatment options.

Our regulatory experts stay at your disposal for any questions. Please do not hesitate to contact us.

21.07.2022
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