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NCMMD is an independent body in the coordination of the Health Minister and the President of the Academy of Medical Sciences, whose members were selected by the Minister of Health no. 34/09.01.2014, following the proposals of Academy of Medical Sciences, on the basis of the General Assembly elections.
Regarding the educational background of its members, on the web page of the committee it can be found that NCMMD includes members such as professional scientists, professionals in the health care, lawyers and people with expertise in ethics. Other relevant disciplines are required like: epidemiology, clinical pharmacology, pharmacy, psychology, sociology and biostatistics.
Related to the organizational structure of the NCMMD, Fig 1 present a chart also available on the web page of the committee:
Figure 1 National Commission of Medicines and Medical Devices, OMS no. 34/2010 organization chart
Concerning the conflict of interest, according to Order no. 398 of 21 March 2013 (*updated) for the consultative commissions of the Ministry of Health (*Updated till date September 14, 2016) (link-Ro), "the members of an advisory committees are submitted to the Ministry of Health criteria, regarding the confidentiality and the conflict of interest, according to the regulations of the organization and its functioning (Article 7, (1)). This declaration has to be updated each year (Article 7, (3)).
On the webpage of the committee there is also available information related to the status of submitted and approved clinical studies. For more details, please consult this link.
Website of the NCMMD: http://en.bioetica-medicala.ro/
NAMMD is a public institution subordinated to the Ministry of Health, established through Government Emergency Ordinance no. 72 of 30 June 2010, whose first mission is to protect and promote public health. “The most important strategic objective of the NAMMD is promotion and protection of public health, by the accomplishment of the NAMMD primary role, namely warranty of compliance of authorized medicinal products with the required standards and intended purpose as well as of their acceptable level of safety”.
An organizational chart of NAMMD is illustrated below in Fig 2, as it appears on the committee web page:
Figure 2 Organizational chart for National Agency of Medicines and Medical Devices
Some legislations of Medical Bioethics from Romania:
a) Concerning the ethical review of biomedical research, it is mandatory to obtain the favorable opinion of NCMMD (1) for conducting a bio-medical research (clinical drug trials – CDT; for details about the ethics approval networking for clinical research except for CDT, consult point d) from below).
b) The interaction procedure between National Committee of Medicines and Medical Devices (NCMMD) (1) and the National Agency for Medicines and Medical Devices (NAMMD) (2) is established only regarding a clinical drug trial and is stipulated in The decision No. 25/03/07/2015 - approving the amendment and completion of the Annex No.6 / 04.22.2014 regarding the approval of the Regulations on the authorization by the National Agency for Medicines and Medical Devices of clinical trials:
“a clinical trial may begin only if NAMMD authorized the clinical trial and NCMMD submitted a favorable opinion” (Unic Art., (3))
c) The Institutional Ethics Committees (IECs) (4) have only a consultative status regarding bio-medical research. Concerning non-biomedical research, the IECs decide for the research activity from their own institutions, meaning that they review and issue approvals for these research activities. A centralized system of those IECs it is not yet available.
d) There is no procedural interaction between the national committees [(1), (2)] and the IECs (4) during the approval process of a bio-medical research application (including clinical research other than CDT, research with biological materials)/non bio-medical research application. The research application may be submitted in parallel to the national competent authority and to the institutional ethics committees.
This report has been prepared by Ms. Loredana Dan, fellow of the Advanced Certificate Program in Research Ethics in Central and Eastern Europe, supported by the Fogarty International Center of the National Institutes of Health, Award Number R25TW007085.