Assessment of Knowledge and Perceptions of Drug Regulatory Affairs among Pharmacists and Pharmacy Students

Haribabu Nali; Madhavilatha T; Audinarayana Nelavala; Jothieswari D

doi:10.37022/jcscr.v5i1.849

Nali Haribabu II Year M.Pharmacy, Department of Drug Regulatory Affairs, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Chittoor – 517127.
T Madhavilatha Assistant Professor, Department of Pharmaceutical Analysis, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Chittoor – 517127.
Audinarayana Nelavala Associate Professor, Department of Pharmaceutics, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Chittoor-517127
D Jothieswari Professor & Principal, Department of Pharmaceutical Analysis, Sri Venkateswara College of Pharmacy (Autonomous), RVS Nagar, Chittoor – 517127

DOI https://doi.org/10.37022/jcscr.v5i1.849

Abstract

A vital part of the pharmaceutical industry, regulatory affairs (RA) includes important tasks such drug registration, product development, and post-marketing surveillance to guarantee the effectiveness, safety, and quality of pharmaceuticals. The purpose of this study was to assess Jordanian pharmacists' and pharmacy students' knowledge and comprehension of Regulatory Affairs and Drug Registration (DR). A structured questionnaire was used in a cross-sectional survey that was disseminated via social media, such as WhatsApp, to pharmacy students and pharmacists from different industries. Of the 411 respondents, 193 (47.0%) were pharmacists and the remainder respondents were students. The results showed that nearly half of the participants had little knowledge of the duties and obligations of RA professionals, and the majority of participants (77.4%) had not received any formal education related to RA during their undergraduate studies. The majority of responders underlined the necessity of better educational activities, including training courses, seminars, and lectures. Overall, the study reveals a sizable knowledge and awareness gap regarding regulatory affairs, indicating the necessity of adding RA-related courses to pharmacy curriculum and enhancing the function of regulatory organizations in order to better train next professionals.

Keywords: Regulatory Affairs, Drug Registration, Pharmacists, Pharmacy Students and Awareness

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