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Trends in Drug Delivery Review Article

Innovations in Oral Drug Delivery: Challenges and Opportunities

  1. Sudipta Roy Department of Pharmaceutics, Bengal College of Pharmaceutical Technology, Dubrajpur

Abstract

The advancement of novel drug manufacturing technologies offers immense opportunities for innovation but brings regulatory complexities that must be addressed to ensure successful implementation. Early and frequent collaboration with the FDA is fundamental for overcoming these challenges. The establishment of the FDA’s Emerging Technology Team has been pivotal in fostering open dialogue, brainstorming, and feedback between regulators and innovators, reducing the likelihood of unexpected setbacks that could jeopardize projects. Mechanisms to evaluate technologies outside individual product submissions, such as pilot programs for novel excipients, provide a framework for ensuring reproducibility and quality, while mitigating risks associated with untested approaches. Global regulatory harmonization is another critical area for improvement. The lack of alignment among jurisdictions often creates delays and increases costs, requiring companies to maintain multiple product versions until all approvals are secured. Programs like the European Mutual Recognition Procedure and FDA’s Project Orbis highlight the benefits of international cooperation in streamlining approval processes. For emerging technologies such as microparticles and nanoparticles, the development of standardized regulatory guidelines is essential to facilitate scalability, characterization, and public acceptance. Additionally, regulatory incentives, such as exclusivity periods and monograph development for novel excipients, could drive innovation and encourage broader adoption. Relaxing similarity requirements for generics and biosimilars may also enhance manufacturability and patient outcomes. By fostering collaboration, harmonizing international regulations, and proactively addressing gaps in guidance, stakeholders can accelerate the adoption of cutting-edge technologies, delivering high-quality, safe, and effective drug products to patients more efficiently.

Keywords

References (14)

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