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What is the authorisation procedure for conducting clinical trials in your jurisdiction?
According to National Agency for Medicines and Medical Devices Scientific Council Decision 2/2014, clinical studies must be performed in authorised units only. Unit authorisation is valid for two years and may be extended upon request. The scope of the authorisation, as well as the necessary documentation, differs according to the type of trial the solicitant wishes to conduct (eg, authorisation for clinical studies with therapeutic benefits, authorisation for Phase I clinical trials and authorisation for bioequivalence clinical trials).
The authorisation procedure for conducting clinical studies is regulated by the National Agency for Medicines and Medical Devices Scientific Council’s Decision 6/2014.
According to this, the issuance of an authorisation for performing clinical studies is subject to the following fee structure:
- €1,250 for new substances;
- €1,000 for clinical investigation of medicines not authorised in Romania but authorised in other countries or authorised for marketing, when the study is conducted with regard to aspects which fall outside the medicine’s summary of characteristics;
- €410 for studies performed on products authorised in Romania, used in conformity with their summary of characteristics; and
- €600 for bioequivalence studies.
According to Ministry of Health Order 904/2006 on the implementation of good practices in the performance of clinical studies, such activities are not permitted without a favourable opinion from the National Agency for Medicines and Medical Devices’ ethics committee.
The procedure and documents necessary for obtaining the ethics committee’s opinion are regulated by National Agency for Medicines and Medical Devices Scientific Council Decision 55/2006. The ethics committee’s opinion will be issued within 60 days of a request. The solicitant may request an opinion before filing a request for authorisation or at the same time.
In order to obtain authorisation, the solicitant must notify the National Agency for Medicines and Medical Devices by way of a signed letter of intent with regard to the payment of the authorisation fee and its intention to submit an application, at least two weeks in advance.
Along with the request for authorisation the solicitant must submit the documents listed in Annex 1 to Decision 6/2014 (eg, the opinion of the ethics committee, information about the sponsor and the medicine’s file), in electronic form.
The agency will inform the solicitant of the validity of its request within 10 days of this submission. If it finds the documentation sufficient, it will then issue an authorisation within a maximum of 60 days. Solicitants are encouraged not to bring any important amendments to the initial request after 50 days following the payment of the authorisation fee.
In case of refusal, the solicitant may request that the agency revise this within 30 days.
The authorisation for clinical studies is valid for the period of the study. However, it loses validity if the study does not begin within one year of authorisation being issued.
The solicitant must inform the agency with regard to the study’s start date and any amendments to the study plan. It must also notify it when the study concludes.
How robust are the standard good clinical practices followed in your jurisdiction?
The standard good clinical practices followed in Romania are regulated by Ministry of Health Orders 903, 904 and 905/2006 and are elaborated by the National Agency for Medicines and Medical Devices.
The guidelines are detailed and fit for purpose and closely follow the wording of EU regulations and directives in the field.
Reporting, disclosure and consent
What are the reporting and disclosure requirements for the results of clinical trials?
The reporting and disclosure requirements for the results of clinical trials are detailed in a guide adopted by the National Agency for Medicines and Medical Devices’ Scientific Council, by way of Decision 27/2011.
According to this, conductors of clinical studies must report any serious side effects and certain non-serious side effects or abnormal laboratory results to the sponsor. All serious side effects must be reported within 24 hours and further detailed in subsequent reports.
The sponsor is obliged to report all serious, unexpected side effects which may lead to death, to the relevant bodies within seven days following the receipt of the investigator’s notification. All other serious, unexpected effects must be reported by the sponsor within 15 days. The sponsor also needs to inform all clinical trial conductors and to compile an annual report for the agency.
The agency has an obligation to upload all such information it receives to the Eudravigilance Clinical Trials Module database.
What are the informed consent obligations with respect to clinical trial subjects?
In order to obtain the trial subject’s consent, the investigator needs to inform him or her of the nature, significance, objectives, potential risks and consequences involved in the trial and to provide all relevant documentation. The patient’s consent must be written, dated and signed. Additional safeguards are set out for vulnerable patients, such as minors or incapacitated persons. The trial subject may withdraw his or her consent at any moment without being held responsible in any way.
What are the insurance requirements for clinical trials?
Romanian legislation does not provide for insurance requirements for clinical trials. However, all clinical trials must be conducted under the supervision of authorised medical personnel. Such personnel have an obligation to conclude a professional insurance policy.
What data protection issues should be considered when conducting clinical trials?
All clinical trials are subject to the Personal Data Processing Law (677/2001). According to this, personal health data is considered sensitive and its processing is prohibited without the data subject’s express consent.
Personal health data may be processed only by or under the supervision of health professionals under conditions of professional secrecy.
The National Agency for Medicines and Medical Devices has yet to publish a guide on adequate measures for the protection of clinical trial subjects’ personal data.
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