Drug regulatory affairs under focus: Knowledge and perceptions among pharmacists and pharmacy students

Abstract

Objectives Pharmaceutical product development, registration, and post-marketing surveillance are the main concerns of the Regulatory Affairs (RA) profession in regulated pharmaceutical industries. The RA assumes a pivotal role in ensuring product quality, patient safety, and drug efficacy and constitutes a vital part of the pharmaceutical industry. The current study aims to evaluate the knowledge and understanding of the concept of RA and Drug Registration (DR) among pharmacists and pharmacy students in Jordan. Methods A cross-sectional study was conducted targeting pharmacists in different sectors and pharmacy students to assess knowledge and perceptions of RA and DR in Jordan. The participants were invited to participate by sending the survey link through social media platforms (WhatsApp). Results A total of 411 participants completed the study survey. Among the study participants, 193 were pharmacists (47.0%), while the rest were pharmacy students. The majority indicated that they had never taken a course related to RA during their undergraduate studies (77.4%). About half of the participants lacked awareness of RA personnel responsibilities with most of the participants agreeing that workshops, lectures, and training are required. Interpretation of results and conclusion This study aims to elevate Jordanian pharmacists’ awareness by focusing the efforts on young pharmacists and pharmacy students. This can be achieved by implementing RA courses within the pharmacy curricula and upholding the role of the regulatory bodies in Jordan.