In recent years, the healthcare sector in Tanzania has witnessed a surge of innovative startups determined to tackle pressing health challenges through technological advancements and novel medical devices. Despite this promising growth, these startups face significant hurdles, particularly in navigating the complex regulatory landscape governing health innovations. Recognising these challenges, the Ifakara Innovation Hub (IIH) organised a collaborative open discussion involving key players, including regulatory authorities, industry experts, and innovators. The aim was to address the obstacles health innovators face during their innovation journey and to benchmark both local and international solutions.
The discussion, titled “Navigating the Regulatory Landscape: Knowledge Sharing andLearning from South Africa and Tanzania,” commenced with a presentation by Andre Ten Napel, a representative from the Center for Rapid Prototyping andManufacturing (CRPM). Andre provided a global overview of the regulatory landscape and highlighted various standards through a case study comparing Australia, Europe, and Tanzania. This presentation set the stage by offering a comprehensive view of international practices in comparison to those in Tanzania.
Diving into the specific challenges faced by health startups in Tanzania, the Tanzania Medicine & Medical Devices Authority (TMDA) identified ensuring product quality as a key hurdle. To address this, TMDA offers consultations to startups, guiding them through the standards and requirements necessary to ensure their products are safe for public use. This proactive approach aims to streamline the regulatory approval process and foster a more innovation-friendly environment.
However, even with TMDA's support, startups still encounter stringent policies that are difficult to meet as an emerging company, particularly in operating manufacturing facilities that meet the certification standards required to enter the market or conduct clinical trials. To mitigate this, IIH advocates for the establishment of safe spaces, akin to the "sandbox" approach used in financial technology, but tailored for health innovation. These safe spaces would provide startups with a controlled environment to test and refine their products while working closely with regulatory authorities. This collaborative approach, supported by Mkanda Salama, aims to shorten the journey from ideation to commercialisation by involving regulators early in the process. Mkanda Salama also encouraged TMDA to recognise innovation hubs as designated safe spaces for startups, which would facilitate regulatory approvals and help startups meet the necessary standards more efficiently.
Dr. Gerrie Booysen, the Director from CRPM, emphasised the importance of understanding the regulatory environment before initiating the product development process.Startups need to be aware of the different regulatory authorities involved and the specific requirements based on their product type. By providing clear guidance and support, regulatory bodies can help startups navigate the complex landscape more effectively and reduce the time it takes to bring products to market.
Adding to this, Dr. Salim Abdullah from the Ifakara Health Institute (IHI) highlighted the need for startups to consider the business aspects of their products. He pointed out that the government maintains a list of priority products for importation, and startups can strategically align their innovations with this list to better meet market demands and expedite the regulatory process. This strategic alignment not only facilitates smoother regulatory approvals but also ensures that startups are developing products that address critical needs in the market.
Dr. Athumani Mgumia from the Commission for Science and Technology (COSTECH) encouraged startups to engage with regulatory bodies at various stages of their product development. He highlighted that there is always room for negotiation and collaboration to support startups in meeting regulatory requirements. This ongoing dialogue between startups and regulatory authorities is crucial for building a supportive ecosystem that fosters innovation and growth in the healthcare sector.
In his closing remarks, the IIH Director Masoud Mnonji emphasised collaborative efforts between Hubs, regulatory authorities, industry experts, and startups to pave the way for a more supportive and streamlined regulatory environment for health startups in Tanzania. By addressing the challenges and providing targeted support, these initiatives are empowering startups to innovate and bring their products to market more efficiently. The discussions and partnerships established through these efforts are crucial steps towards transforming the healthcare landscape in Tanzania and ensuring that innovative health solutions are accessible to those who need them most.
As the ecosystem continues to evolve, IIH remains committed to fostering innovation and supporting startups in their journey toward creating impactful health solutions. Through collaboration, education, and strategic partnerships, the future of healthcare innovation in Tanzania looks promising and bright.
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