AD-HOC STUDY OF PHARMA COMPANIES' WILLINGNESS TO CONDUCT PASS/PAES STUDIES IN BULGARIA

Introduction: According to the contemporary data very little part of the developed and clinically tested molecules reach the market. Before being authorized for human use, during the clinical trials, the medicinal product is tested in many different ways. Bulgaria is one of the most preferred countries for conducting clinical trials. According to the current regulation the post-authorization studies are divided into two types – PASS (safety studies) and PAES (studies of efficacy) – also known as phase 4 of the clinical trials, taking place in the real clinical practice with patients. Their aim is identification, quantifying and assessment of the importance of the risks, linked to the use of a medicinal product in the clinical practice. Methodology: A questionnaire composed with the aim to assess the willingness of the pharmaceutical companies in Bulgaria to conduct PASS/PAES has been carried out. Subjects of the study were pharmaceutical companies and representatives of marketing authorization holders (MAH) in Bulgaria – innovative companies, members of the Association of the research-based pharmaceutical manufacturers in Bulgaria (ARPharM) and generic companies, members of the Bulgarian generic pharmaceutical association (BgPharmA).  Results: Currently in international perspective half of the questioned pharmaceutical companies and two of the generic ones conduct PASS with total number of studies varying between 1 and 20 studies per company. Only one of the innovative companies conducts PAES. Nowadays only one of the questioned innovative companies has current PASS and PAES in Bulgaria. Conclusion: The results of the conducted study show that from regulatory and logistic point of view in Bulgaria all the required conditions for conduction of PASS and PAES are present. Although this legal tool is not yet widely popularized in the activities of the regulatory authority and MAHs, the existing conditions have the potential to speed up the development of this sector of the pharmaceutical industry.