Strategies for Overcoming Regulatory and Ethical Challenges in Biopharmaceutical Development

Alessandra Moretti
University of Milan, Italy

DOI:https://doi.org/10.5912/jcb2515

Abstract:

The biopharmaceutical industry faces challenges of regulations, ethics, and law which hinder the processes of drug development, approval, and distribution. The intersection of these regulatory compliance challenges, differing compliance regimes, and geographies needs proactive communications with the FDA and EMA to facilitate the drug approval process. Moreover, the ethical issues such as patient's goodwill, fairness in the provision of health services, data privacy, and confidentiality call for responsible and ethical conduct of research. It has been suggested that some of these challenges can be solved by combining regulatory intelligence with ethical clinical research, artificial intelligence, and blockchain technology to enhance compliance and effectiveness. Also, the cooperation between biopharmaceutical companies, the governmental regulatory bodies, clinicians, and even advocacy groups is essential for the fast-tracking of innovative, safe, and effective solutions. Thus, by combining regulatory reasoning, ethical planning, and technological innovation, the biopharmaceutical industry is capable of addressing these challenges to guarantee efficiency. This, among other important objectives, seeks to assure innovation in the development of therapies while maintaining the quality parameters which include safety, efficacy, and ethics.