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News and Events
30.07.2010
GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE, CPMP/QWP/EWP/1401/98 Rev. 1.
From August 1, 2010 all applications for authorization of clinical trials on bioequivalence, submitted to BDA must fulfill the requirements set forth in GUIDELINE ON THE INVESTIGATION OF ...
14.07.2010
Council of Ministers approved amendments to the Law on Medicinal Products for Human Use (LMPHM).
Council of Ministers approved amendments to the Law on Medicinal Products for Human Use (LMPHM). The document reflects the changes in European regulation of medicinal products, the entry into force ...
28.04.2010
Prof. Anna-Maria Borisova is the new Minister of Health
Today the National Assembly has selected Prof. Anna-Maria Borisova for the position of a Minister of Health. After the meeting of the Council of Ministers Prof. Borisova met her forerunner Dr. ...
26.04.2010
General Assembly of Board of Directors of the Bulgarian Association of Clinical Trials
Board of Directors of the Bulgarian Association of Clinical Trials is pleased to officially invite you to the General Assembly which will be held on 11 June 2010 at 14:00h in Sofia, hotel ...
24.04.2010
Bulgarian Association of Clinical Trials with the co-operation of Institute of Clinical Trials / ICR / UK, organize a course "Introduction to Good Clinical Practice"
Bulgarian Association of Clinical Trials with the co-operation of Institute of Clinical Trials / ICR / UK, organize a course "Introduction to Good Clinical Practice" which will be held on ...
17.09.2008
A New Regulation No7 Issued
The Minister of Health and the Minister of Economics and Energetics have issued Regulation No7 as of 5 Aug 2008 regarding the Terms and Procedures for Taking Samples of Medical Devices for Clinical ...
19.05.2008
New Regulation on Medical Devices issued by the Ministry of Health
On the grounds of Art. 48, para 2 and Art. 58, para 3 of the Medical Devices Act, the Ministry of Health has issued Regulation No10 as of 23rd April 2008 regarding the documentation presented by ...
30.04.2008
A New Draft Regulation Issued by Ministry of Health
The Ministry of Health has issued a Draft Regulation regading the documentation presented by Principal/Coordinating Investigator for opinion by the respective Ethics Committee and the ...
22.04.2008
SOPs of 81 Ethics Committees approved so far
As of 22nd April 2008, the Bulgarian Drug Agency (BDA) has approved the Standard Operating Procedures (SOPs) of the Local Ethics Committees (LEC) of 81 medical institutions in Bulgaria. The LECs ...
19.03.2008
A New Regulation №2 issued by the Ministry of Health
A new Regulation №2 on the requirements for collecting, confirming and providing Adverse Drug Reactions information and for the form and content of immediate reports of ADR notifications and ...
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