Balancing Innovation and Oversight: A Document Analysis of Regulatory Compliance Frameworks

Gordian I. Nweke, Ogochukwu C. Nweke, Samuel C Mocha

Capella University (USA), Regent University College of Science and Technology (Ghana), Colorado Technical University (USA)

Regulatory compliance frameworks provide the mechanism to ensure that innovations adhere to ethical standards and enhance the safety of individuals. However, regulatory frameworks can also stifle innovations if they become too strict. This study, therefore, reviews and compares the innovation regulatory frameworks to ascertain how developed and developing countries balance the promotion of health innovations with the need to enhance public safety and ethical standards in the health industry. The study adopted the qualitative documentary analysis approach and analyzed eight regulatory frameworks from the USA, the UK, the European Union, and Sub-Saharan Africa (SSA). The thematic analysis in analyzing the data guided by four regulatory theories. The findings of the study were discussed under four emerging themes, guided by four regulatory theories. The themes included risk-based stratification, adaptive frameworks, transparency and ethics, and regulatory compliance. The findings showed that regulatory frameworks of developed economies are characterized by high-risk-based stratification regimes, adaptive systems, transparency, and coordinating regulatory systems that constitute an innovation-enabling framework with assured patient security and public confidence. On the contrary, the health regulatory environment in SSA is still under development and is marked by irregular regulation, low capacity, and an increasing focus on regional harmonization through frameworks. Regulatory bodies and decision-makers in SSA can learn from the successful mechanisms of developed countries and tailor their strategies to local realities. This can ensure that innovations in health are not merely effective and safe but also accessible to those who most need them

Article link: https://www.asianinstituteofresearch.org/lhqrarchives/balancing-innovation-and-oversight%3A-a-document-analysis-of-regulatory-compliance-frameworks