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The leading positions in the Romanian National Drug Agency (ANMDMR) blocked by the Ministry of Health

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The leading positions in the Romanian National Drug Agency (ANMDMR) blocked by the Ministry of Health

The competition to recruit the president and vice president of the Romanian National Drug Agency (ANMDMR) scheduled for November 6, 2019 has been postponed for subsequent dates.

The information is available from an announcement of the Ministry of Health General Directorate of Legal and Human Resources, document consulted by 360medical.ro.

The contest scheduled on November 6th at 11:00 am, was announced by ANMDMR on October 21st, and the applications had to be submitted to the Ministry of Health headquarters by October 25th. The initial announcement specified that only graduates of medicine, economics or law can enroll.

The College of Pharmacists from Romania through the press release no. 3537 / 22.10.2019 mentioned that the "elimination" of the pharmacists from the list of candidates is a discrimination and abuse, and the period of only 4 days for submitting the file proves the lack of transparency in the ANMDMR competition organizing process.

Two days before the deadline, the announcement was updated giving to graduates of the pharmacy faculties the possibility to enroll in the competition. On the occasion of checking the files on October 28 and 29, two candidates were rejected. On November 6, the contest was to be organized, subsequently postponed.

On November 7, ANMDMR has announced on its website the postponement of the competition for the position of head of Human Resources and Quality Management until a later date that will be announced by legal means of information.

ANMDMR is the national regulatory authority for clinical trials in our country, together with the National Commission for Bioethics of Medicines and Medical Devices in Romania.

According to the European Directive 2001/20 / EC transposed in the Romanian legislation, the approval period for clinical trials must be of maximum 60 days, while in Romania in 2016 reached 175 days, increasing in time to +400 .

According to the World Health Organization, in 2018 in Europe 11,291 clinical studies have been carried out, while in Romania only 245. The report "Clinical Studies in Romania - 2016" made by KPMG for the CRO Romanian Associations (ACCSCR) and Romanian Association of International Drug Manufacturers (ARPIM), mentions that Romania ranks 6th in the ranking of the number of clinical studies performed in Central and Eastern Europe and the leader is Poland.

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Posturile din conducerea ANMDMR blocate de Ministerul Sanatatii

Concursul pentru ocuparea posturilor de presedinte si vicepresedinte ai ANMDMR din data de 6 noiembrie 2019 a fost amanat pentru o data ulterioara.

Informatia provine dintr-un anunt al Directiei Generale Juridice si Resurse Umane din Ministerul Sanatatii, document consultat de 360medical.ro.

Concursul prevazut sa aiba loc pe 6 noiembrie la ora 11:00, a fost anuntat de ANMDMR pe 21 octombrie, iar dosarele de înscriere trebuiau depuse la sediul Ministerului Sanatatii pana pe 25 octombrie. In anuntul initial se specifica faptul ca se pot înscrie doar absolventi de medicina, economie sau drept.

Colegiului Farmacistilor din Romania prin comunicatul de presa nr. 3537/22.10.2019 a luat atitudine mentionand ca “eliminarea” farmacistilor din lista de candidati este o discriminare si un abuz, iar perioada de doar 4 zile pentru depunerea dosarului dovedeste lipsa de transparenta a ANMDMR in organizarea concursului.

Ulterior, cu doua zile inainte de data limita, anuntul a fost actualizat dand astfel posibilitatea de inscriere la concurs si absolventilor facultatilor de farmacie. Cu ocazia verificarii dosarelor in 28 si 29 octombrie, doi candidati au fost respinsi, urmand ca pe 6 noiembrie sa fie organizat concursul, ulterior amanat.

In data de 7 noiembrie, ANMDMR a anuntat pe site-ul sau si amanarea concursului pentru postul de sef al Directiei Resurse Umane si Managementul Calitatii pana la o data ulterioara care va fi anuntata prin mijloace legale de informare.

Alaturi de Comisia Nationala de Bioetica a Medicamentului si Dispozitivelor Medicale din Romania, ANMDMR este autoritatea de reglementare pentru studii clinice din tara noastra.

Cf. Directivei Europene 2001/20/EC transpusa in legislatia romaneasca, termenul de aprobare pentru studii clinice trebuie sa fie de maxim 60 de zile, in timp ce in Romania ANMDMR in 2016 a aprobat in 175 de zile, crescand in timp la +400.

Conform Organizatiei Mondiale a Sanatatii, in 2018 IN Europa s-au desfasurat 11.291 de studii clinice, in timp ce in Romania doar 245. Romania ocupa locul 6 in clasamentul numarului de studii clinice efectuate in Europa Centrala si de Est, liderul fiind Polonia, mentioneaza Raportul “Studiile Clinice in Romania 2016” realizat pentru ACCSCR si ARPIM de catre KPMG.

Posted on: 14 November 2019