Collaboration to fast-track medicine approval procedures

The WHO estimates that over two billion people do not have access to essential medicines for treating serious diseases. This affects people all over the world, but especially those in Africa and Asia. Oxfam has estimated that over three million children under the age of 15 die every year because they do not receive the most important vaccinations and medicines.

There are several reasons for this situation. "First of all, innovative, efficacious and safe treatments are still lacking for many poverty-related diseases. Even if such treatments exist, the distribution of medicines in remote areas is often difficult. There is also a chronic shortage of trained medical personnel and adequate healthcare facilities to correctly administer these medicines. Lastly, there is no reliable approval procedure for medical products – an aspect that is often forgotten," emphasises Alexander Schulze, head of the SDC's Global Programme Health.

In some low and middle-income countries, the evaluation and registration process for a medical product can take up to seven years. Switzerland has been supporting international efforts to improve and speed up access to high-quality medicines, especially in sub-Saharan Africa through the Accelerate Registration of Medical Products initiative and through a unique collaboration between Swissmedic – the Swiss Agency for Therapeutic Products – and the SDC.

The national medicines regulatory authorities (NMRAs) in many African countries do not have sufficient financial resources or expertise to evaluate and approve medicines for efficacy, safety and quality within reasonable timelines. "Swissmedic shares its registration and scientific advisory procedure with low and middle-income countries to shorten the process and make it more transparent. The objective is to build capacity," explains Lodovico Paganini, a scientific advisor at Swissmedic. Switzerland therefore works closely with the WHO to strengthen NMRAs in Africa.

After an extensive preparatory phase, the first tangible result of the Marketing Authorisation for Global Health Products (MAGHP) was achieved with the registration of Carbetocin Ferring. It is an injectable solution to prevent excessive bleeding after childbirth. Every year, 70,000 women die of post-partum haemorrhage. Experts from Uganda, Kenya, Tanzania, South Sudan, the Democratic Republic of the Congo and Ethiopia participated in the assessment procedure.

"By actively participating in the entire process, African experts are able to enhance their knowledge and establish confidence in the procedure. They can also make suggestions relating to country-specific issues or needs," explains Paganini. "They are familiarised with the product documentation by Swissmedic, which should shorten the time needed to approve the product by national regulatory authorities." Product approval should not take more than 90 days from submission of the application by the manufacturer. This has already been achieved in Ghana and Tanzania where Carbetocin Ferring was registered within three months.

Last February, the SDC, Swissmedic, the WHO and NMRA representatives from Ghana and Tanzania gave a presentation on their experience and highlighted the strengths and future challenges of the MAGHP process to 120 participants at an online conference. "The conference generated a lot of interest in the initiative, even amongst pharmaceutical companies," says Paganini. "The NMRAs can only approve products within a shorter timeframe if the pharma companies submit an application under this procedure."

The project is also promoting collaboration between countries and regions in Africa to accelerate and ensure the quality of approval procedures across the continent and at a regional level. "It would be a waste of time and resources if we do not use the data and results of other regulatory authorities," says Schulze.

The initiative also proposes to harmonise national medicine registration procedures within regional economic communities and to create a platform for sharing knowledge and documentation at a pan-African level. For example, common guidelines and instruments were developed to ensure the quality, safety and efficacy of pharmaceutical products.

The third pillar of the initiative are training programmes to strengthen and build capacities. Swissmedic and the WHO jointly organise four-day courses twice a year for participants to acquire new knowledge, for instance in the areas of approval procedures for medicines, quality control and market monitoring. "We also facilitate foreign experts accompanying a team of Swissmedic inspectors during inspections of medicine manufacturing sites," notes Paganini.