Title:The Basic Overview of Drug Regulatory Affairs in the Pharmaceutical Industry
Volume: 12
Author(s): Vaibhav Khadul, Sunayana Mali and Audumbar Mali*
Affiliation:
- Department of Pharmaceutics, Sahyadri College of Pharmacy, Methwade, Sangola, 413307, Solapur, Maharashtra, India
Keywords:
Regulatory affairs, regulatory authorities, pharmaceutical marketing authorization, quality and risk management, quality assurance handbook, post-marketing activities.
Abstract:
For the pharmaceutical industry, Regulatory Affairs (RA) are crucial. While RA was
initially established to facilitate the introduction of new products to the market, maintaining
regulatory approval is as important as obtaining it. The aim of this review was to provide an
overview of the role of RA in pharmaceutical industries and regulatory authorities, and to analyze
the functions of various regulatory institutions in key developed and emerging nations, highlighting
the challenges these organizations face in delivering healthcare services.
This study emphasizes that the role of RA is vital during both the pre-development and postdevelopment
phases of medicines, given the important role of medicines in health. RA serves as
the interface between the regulatory agency and the project team, enabling effective communication.
Regulatory provisions must be followed when drafting the project plan to ensure compliance
and product clearance.
RA has several key responsibilities, including ensuring compliance, obtaining approvals from
various regulatory bodies, providing guidance on drug approval, and offering technical support
to the Research and Development (R&D) and production departments. RA specialists operate at
the intersection of business, law, and pharmacy, assessing whether regulations are being followed.
The RA department plays a critical role throughout the pharmaceutical lifecycle, from the
initial development of dosage forms to post-marketing activities. It also assists pharmaceutical
companies in preparing regulatory strategies and compiling regulatory documents.
