Streamlining Regulatory Compliance: Core Dossier Development for EU and US Filings (KEY IJP************160)

• Ajmalkhan.m, Dr.k,jaganathan, Dr.b.senthil Kumar, Dr.n.senthil Kumar

Abstract

Pharmaceutical companies are under intense global economic pressure to enhance the value of their assets and expand into new markets. However, they encounter significant challenges such as regulatory delays and submission failures during initial filings. By adopting proactive regulatory strategies, companies can optimize their product portfolios and avoid these issues. Simultaneously, governments are feeling the strain to reduce healthcare expenditures due to aging populations, economic slowdowns, and increasing drug prices. The European Union (EU) and the United States (US) have distinct regional and technical standards for generic drugs. In the US, regulatory information is submitted to the FDA via the Electronic Common Technical Document (eCTD), while the EU operates a centralized system for single applications. Generic medicines must demonstrate pharmaceutical equivalence, conduct bioequivalence studies, and provide clinical evidence supporting safety and efficacy in both markets. These differences must be fully understood to achieve faster drug approvals and ensure patient access to safe and effective generics.