Regulatory Challenges in The Approval of New Pharmaceuticals
Year: 2025
Type: article
Abstract: Drug development and regulation are complex, resource-intensive processes that differ greatly between nations. Examining the global drug regulatory environment, this analysis emphasizes the complexities of medication approval, post-market surveillance, and discovery. It looks at how regulatory affairs helps pharmaceutical businesses and regulatory authorities communicate while maintaining adherence to local, national, and international regulations. Important regulatory bodies are covered, along with their approval procedures and regulatory obstacles, such as the FDA (USA), EMA (EU), CDSCO (India), and others. The review highlights the difficulties In approving drugs, including issues with safety, effectiveness, data integrity, and political and economic factors. The report also highlights the increasing significance of gene therapy, personalized medicine, and repurposed medications, illustrating how scientific and technical advancements have affected regulatory procedures. In order to simplify medication laws and improve access to efficient treatments worldwide, it finishes by looking at international harmonization initiatives, especially those carried out by the International Council for Harmonization (ICH). To effectively address the demands of global healthcare, the changing environment of drug regulation necessitates flexible, open, and cooperative approaches.
Author: Dhanashri Patil, Gautami Gholap, Hemant Raut*, MRN Shaikh
Language: English
Topic: Healthcare Regulation
Subfield: Health Information Management
Field: Health Professions
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6893331385
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