Ayyash Manal A, Nassar Razan I, Al-Muhtaseb Raghad, Jaber Kamel A
Department of Pharmaceutics and Pharmaceutical Science, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan.
Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan.
PLoS One. 2025 Mar 27;20(3):e0320599. doi: 10.1371/journal.pone.0320599. eCollection 2025.
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.
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).
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.
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.
药品研发、注册及上市后监测是受监管制药行业中监管事务（RA）专业的主要关注点。监管事务在确保产品质量、患者安全和药物疗效方面发挥着关键作用，是制药行业的重要组成部分。本研究旨在评估约旦药剂师和药学专业学生对监管事务和药品注册概念的了解情况。
开展了一项横断面研究，以不同部门的药剂师和药学专业学生为对象，评估约旦对监管事务和药品注册的知识及认知情况。通过社交媒体平台（WhatsApp）发送调查链接邀请参与者参与。
共有411名参与者完成了研究调查。在研究参与者中，193人是药剂师（47.0%），其余为药学专业学生。大多数人表示他们在本科学习期间从未上过与监管事务相关的课程（77.4%）。约一半的参与者对监管事务人员的职责缺乏认识，大多数参与者认为需要举办研讨会、讲座和培训。
本研究旨在通过关注年轻药剂师和药学专业学生来提高约旦药剂师的认识。这可以通过在药学课程中开设监管事务课程并维护约旦监管机构的作用来实现。
