Preclinical & Clinical Trial Requirements
An intro to the legal situation for preclinical and clinical trial requirements in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
The Romanian law does not expressly provide such limitation as to the performing of clinical trials solely in Romania in view of obtaining the marketing authorization for a certain medicinal product.
2. How are clinical trials funded?
A clinical trial is normally financed by its sponsor, who can delegate certain financial operations to a contract research organization (“CRO”).
The payments made by the sponsor and/or the CRO are used for the financing of all activities for implementing the trial in accordance with its protocol, including without limitation, for the payment of the fees of investigators and of the services performed by healthcare institutions.
The financing of the clinical trial and the relevant agreements to be concluded with the investigators and with the institutions are assessed by NAMMD / Ethics Committee, when submitting the application for performing the clinical trial in Romania.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
According to the applicable regulations, the clinical trial protocol should provide:
- general information regarding the sponsor, investigators and laboratories;
- certain information regarding the investigated product, its use and the target population;
- the clinical trial’s objectives;
- the selection and withdrawal of the subjects;
- the treatment administered to the subjects;
- the evaluation of the trial’s efficacy and safety;
- statistical information;
- quality assurance and quality control provisions;
- ethical aspects;
- data processing aspects;
- financing, insurance and certain other aspects provided by the clinical trial guidelines.
In order to perform clinical trials in Romania, it is required to obtain an authorization from the National Agency for Medicines and Medical Devices (“NAMMD”) and the favorable opinion of the National Bioethics Committee for Medicinal Products and Medical Devices (“NBCMMD”), which shall assess, inter alia, the clinical trial protocol.
As part of the authorization procedure, NBCMMD should issue a prior opinion on the trial and its protocol. Any major amendment to the clinical trial protocol should be approved by NBCMMD and the NAMMD, before its implementation.
4. What are the requirements for consent by participants in clinical trials?
Subjects participating in clinical trials should give their written, dated and signed consent, willingly expressed after receiving adequate information concerning the nature, significance, possible consequences and risks of the trial, before their inclusion in the trial.
In the case of minors and persons unable to give an informed consent, it is their legal representative’s responsibility to provide the required consent. Also, if the trial subject is unable to write, they can verbally give the consent in the presence of at least one witness.
The clinical trial subjects have the right to withdraw their written consent anytime, at their sole discretion.
5. May participants in clinical trials be compensated?
Clinical trial subjects cannot be paid or receive other financial advantages for their participation in clinical trials. Certain limited expenses, such as travel costs, could be reimbursed in accordance with the clinical trial protocol.
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The protection of clinical trial subjects is ensured by adequate medical supervision, aimed at identifying and reporting any adverse reactions and other issues during the clinical trial. The reports on adverse reactions are submitted with the regulatory authorities.
In order to indemnify the subjects, the sponsor should conclude an insurance agreement with an insurance company, otherwise NAMMD shall not approve the performance of the clinical trial in Romania.