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OPERATING REGULATIONS
OF THE
NATIONAL MEDICINES AND MEDICAL DEVICES BIOETHICS
COMMITTEE IN ITS RELATIONS WITH COMPANIES ORGANIZING
CLINICAL STUDIES
CNBMDM shall gather whenever required and at least once a month, with an active quorum of at least ½
+1 of its members.
The current working manner of the committee consists of the separate review of the files, by each member
of the committee or at least ½ +1 of its members (at least 6 signatures). The experts hired by CNBMDM in order
to review the clinical study files have the same voting rights as the committee members appointed through the
order passed by the Minister of Health. The fact that the committee members reviewed the file is certified by the
signature thereof affixed on the attached sheets. The members of the management board of CNBMDM may be
part of the members that review the clinical files and are entitled to vote. In case of observations concerning the
contents or presentation of the file, such observations are mentioned in a separate, attached sheet. The expressed
observations are reviewed by the President, Vice President or Secretary of the committee and, depending on the
contents thereof, may generate the following effects:
 review of the file by the committee office, which resolves on the attitude to be taken;
 review of the file during the next meeting of the committee or during a special meeting;
 request for the opinion of external consultants.
The outcome of a file’s review may consist of:
 the rejection of such file as ethically incompatible;
 postponed issuance of the file approval until the applicant remedies the issues set out by one
or more referents;
 approval of the file, with the issuance of a grounded approval concerning the performance of
such trial, signed by the President or Secretary General.
The settlement term of a clinical study file is of maximum 60 days after the submission of the complete
file and confirmation that the fee related to the trial stage was paid (30 days for non-interventional studies).
If the clinical study file is not complete on the registration date thereof, the applicants, within 30 calendar
days (and without exceeding such term), are entitled to submit the required supplementations. The committee shall
provide an answer within the legal term, which shall not exceed the 60-day term.
If, during the file review, CNBMDM requests certain amendments or supplementations, the settlement
term stops (to the number of days elapsed until such request for amendments/supplementations), and is resumed as
of the effective date of the required changes.
For amendments or other type of correspondence filed with CNBMDM, the settlement term is of 35
calendar days as of the registration date of such documents. The approval of acknowledgements is signed by each
member of the management board of CNBMDM.
The structure of CNBMDM, according to the Minister of Health Order no. 34/ 2010 is as follows:
SCHEDULE
(Schedule to Order no. 1.446/2009)
STRUCTURE
of the National Medicines and Medical Devices Bioethics Committee
President: acad. prof. dr. Dinu Antonescu
Vice President: acad. prof. dr. Aurelia Cristea
Secretary: acad. prof. dr. Constantin Mircioiu
Members:
- acad. prof. dr. Ludovic Păun;
- acad. prof. dr. Sava Dumitrescu;
- dr. farm. Speranţa Prada;
- prof. dr. farm. Elena Chiriţă;
- dr. farm. Brânduşa Rădulescu;
- prof. dr. Aurel Ardelean;
- episcop vicar de Bucureşti Varsanufie Gogescu;
- manager public jr. Monica Isăilă.
Representatives of participants in the studies:
- Ovidiu Moldovan. MD;
- dr. farm. Flavian Rădulescu.
Comisia Naţionala de Bioetică a Medicamentului şi a
Dispozitivelor Medicale
Preşedinte
Data: 01.03.2014