Bridging access and compliance: Transforming regulatory pathways for pharmaceutical startups in Africa
1 University of Lagos, Department of Public Health, Lagos State, Nigeria.
2 Altru Health System, Family Medicine, Grand Forks, North Dakota, USA.
3 University of Washington, Global Health, Washington, USA.
4 University of Portharcourt, Parasitology, Health Safety and Environment, Rivers State, Nigeria.
Review Article
World Journal of Advanced Research and Reviews, 2019, 04(01), 088-107
Article DOI: 10.30574/wjarr.2019.4.1.0134
Publication history:
Received on 20 November 2019; Revised 25 December 2019; accepted on 28 December 2019
Abstract:
The article reports the intersection of market access to the African drugs market with the need for regulatory compliance with specific reference to managing entry challenges or establishment within the market by start-ups. As well as the pharma market in the world operating under scale-up development pressure and innovation, African pharma start-ups must cope with novel challenges of disintegrated regulatory regimes, inconsistent regulation enforcement, technical capacity deficits, and poor infrastructure. These are all a core challenge in the field of entry and sustainability to the market, deterring innovation and public availability of life-saving drugs.
The report urges a paradigm shift in the African regulatory landscape to enable early-stage pharma firms without undermining quality, safety, and public health. It provides a strategic approach that makes it easier to comply with start-ups through regulation harmonization, regulatory and digital technologies (RegTech), and innovative public-private partnerships. The strategies are intended to enable streamlining of the regulation, prevent duplicative efforts at the national level, and enhance transparency and accountability.
In this book, digital channels and cooperative systems will cross borders and introduce a well-designed system that will facilitate innovation without encroaching upon the regulative sanctity. Regionally targeted frameworks and policies can make the regulation burden lighter for start-ups to continue innovating and inexpensive health solutions. Hence, the article gives the stakeholders concrete tips on how best to implement an inclusive, effective, and innovation-friendly regulatory environment in the pharma sector on the continent.
Keywords:
Regulatory Compliance; Pharmaceutical Markets; Africa; Startups; Innovation; Fragmented Systems; Infrastructure; Regtech; Harmonization; Public-Private Partnerships
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Copyright © 2019 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0