Conducting clinical trials in five Eastern European countries (EU-EECs) with a focus on Bulgaria-Reference-Cited by-同舟云学术

Conducting clinical trials in five Eastern European countries (EU-EECs) with a focus on Bulgaria

Published:2023-07-02 Issue:1 Volume:37 Page:
ISSN:1310-2818
Container-title:Biotechnology & Biotechnological Equipment
language:en
Short-container-title:Biotechnology & Biotechnological Equipment

Author:

Benisheva Tatyana¹,Milkov Dimitar¹,Kopanarov Valentin¹,Ivanov Ivaylo²,Dimitrov Dimitar¹,Todorova Veselina¹,Dzhafer Nigyar¹,Chavkova Iva¹,Todorova Lyubina³,Gebert Lena⁴

Affiliation:

1. Department of Health Policy and Management, Faculty of Public Health, Medical University of Sofia, Bulgaria

2. Pharmaceutical Research Associates Bulgaria EOOD, Sofia, Bulgaria

3. Department of Marketing Authorisation of Medicinal Products, Bulgarian Drug Agency, Sofia, Bulgaria

4. Global Regulatory Oncology Division, Merck Healthcare KGaA, Darmstadt, Germany

Publisher

Informa UK Limited

Subject

Biotechnology

Link

https://www.tandfonline.com/doi/pdf/10.1080/13102818.2023.2226741

Reference46 articles.

1. European Medicines Agency. Guideline for good clinical practice E6(R2) 2016 https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-good-clinical-practice-e6r2-step-5_en.pdf. (accessed January 31 2023).

2. European Parliament and European Council. Regulation (EU) no 536/2014 of the European parliament and of the council of April 16 2014 on clinical trials on medicinal products for human use and repealing directive 2001/20/EC text with EEA relevance. Directive 2001/20/EC Text with EEA relevance 2014 OJ L 158 27.5. p. 1–7. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32014R0536 (accessed January 31 2023).

3. European Parliament and European Council. DIRECTIVE 2001/83/EC of the EUROPEAN PARLIAMENT aND of the COUNCIL of november 6 2001 on the community code relating to medicinal products for human use. 2001 OJ L 311 28.11. p. 67. https://health.ec.europa.eu/system/files/2016-11/dir_2001_83_cons_2012_en_0.pdf (accessed January 31 2023).

4. EU Clinical Trials Register. https://www.clinicaltrialsregister.eu. 2023 accessed January 31 2023).

5. Bulgarian Drug Agency. Annual activity reports 2002–2021 https://www.bda.bg/en/useful-links/138-about-bda-en/916-annual-reports-bda-en. (accessed January 31 2023)