Pharmaceutical companies Infinity Health and IntraHub team up to automate regulatory compliance within Africa's pharmaceutical sector
The pharmaceutical landscape in Africa is set for a significant transformation, as Infinity Health Africa and IntraHub Africa join forces to automate and digitise regulatory compliance and quality assurance. This partnership aims to create a more rigorous, tech-enabled regulatory environment, fostering digital transformation, better health outcomes, and regulatory trust.
The collaboration brings together Infinity Health Africa, a Nigerian regulatory technology and market access company, and IntraHub Africa, a pharmacovigilance service provider. With a shared vision, they aim to strengthen regulatory documentation, enhance Good Manufacturing Practice (GMP) certification readiness, and build robust pharmacovigilance and patient safety systems.
IntraHub Africa's IntraVigiTM platform, which enables drugmakers and health providers to track adverse drug reactions (ADRs), maintain safety reports, and comply with international pharmacovigilance standards, will be integral to this partnership. Similarly, Infinity Health's proprietary platform ONBOARD, which manages product registration, licensing, and post-marketing surveillance, will play a crucial role in simplifying the submission process and supporting local and international regulatory audits.
The partnership is timely, given the increasing regulatory scrutiny across Africa. For instance, Nigeria's National Agency for Food and Drug Administration and Control (NAFDAC) now requires mandatory bioequivalence studies for all generic drugs submitted for registration. Meanwhile, Kenya's Pharmacy and Poisons Board introduced new pharmacovigilance and post-market surveillance rules in mid-2022.
This partnership is poised to shape a more rigorous and tech-enabled regulatory environment for pharmaceutical companies across Africa. By leveraging their combined experience of managing over 200 regulatory submissions, they aim to promote regulatory excellence and patient safety throughout pharmaceutical operations.
As the African pharmaceutical market is projected to grow to $70 billion by 2030, this collaboration could not come at a better time. The partnership is expected to help pharmaceutical companies across Africa become more compliant, competitive globally, and ensure safer healthcare outcomes for patients.
Pharm. Abubakar Mukhtar, CEO of IntraHub Africa, expressed his excitement about the partnership, stating that it brings together expertise, technology, and a shared vision. He further added that the partnership will simplify tracking and analysis of drug reactions, making it easier for pharmaceutical companies to navigate the complex regulatory landscape in Africa.
The collaboration is not just about regulatory compliance; it's also about fostering innovation and creativity. The Moonshot event, featuring Africa's top founders, creatives, and tech leaders, is returning to Lagos on October 15-16. Early bird tickets for the event are currently 20% off, offering an opportunity for industry leaders and enthusiasts to engage, learn, and network.
[1] Infinity Health Africa [2] IntraHub Africa [3] NAFDAC [4] Pharmacy and Poisons Board (Kenya)
1) This collaboration between Infinity Health Africa and IntraHub Africa signifies a promising development in the African pharmaceutical landscape, as both entities aim to integrate technology into regulatory compliance and quality assurance for better health outcomes, using platforms such as IntraVigiTM and ONBOARD.
2) With a shared focus on improving pharmacovigilance and patient safety, Infinity Health Africa and IntraHub Africa are working closely to strengthen regulatory documentation, enhance Good Manufacturing Practice (GMP) certification readiness, and upgrade pharmacovigilance and patient safety systems across the continent.
3) As new regulatory requirements are being introduced by agencies like NAFDAC (Nigeria) and the Pharmacy and Poisons Board (Kenya), the utilization of advanced technologies in therapies and treatments, health-and-wellness, medical-conditions, and nutrition will become increasingly important in ensuring industry compliance and fostering global competitiveness, ultimately leading to improved health outcomes for patients in Africa.
