A comprehensive examination of regulatory affairs awareness in several pharmacy industries
The registration process for various pharmaceutical products and new drug applications is the primary responsibility of the pharmaceutical drug regulatory affairs department. In the pharmaceutical industry, regulatory affairs (RA) specialists are essential due to their involvement with medical devices. RA offers operational and strategic guidance to accelerate the development of pharmaceutical, biological, and medical devices while working within legal constraints. Its main concerns include ensuring safety, effectiveness, low risk/high reward, and quality evaluation of pharmaceutical products used globally. Different regulatory authorities regulate certification and good manufacturing practices in each country’s regulatory framework. RA also plays a specialized role in drug product development. This abstract highlights research on awareness and knowledge testing in regulatory affairs, conducted among pharmaceutical professionals. A certified online survey, based on key RA concepts, was shared with over 1,000 professionals (academics, students, and industry experts). The results show that industrial professionals possess greater knowledge of RA than scholars and students. The survey concludes that RA education should be incorporated into academic curricula to meet future demands.
Authors
- V Ramadoss
- N Audinarayana
- P Pravallika
Institutions
- Sri Venkateswara University (IN)
- Sri Venkateswara Veterinary University (IN)
Publication Details
- Journal
- International Journal of Research in Pharmaceutical Sciences
- Published
- 2025-05-25
- DOI
- https://doi.org/10.26452/ijrps.v16i2.4777
- Primary Topic
- Pharmaceutical Quality and Counterfeiting
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- College ter Beoordeling van Geneesmiddelen
- Ministry of Health, Labour and Welfare
- Uganda National Council for Science and Technology
- Health Canada