Regarded as one of the world’s leading regulatory bodies, Swissmedic stands alongside its equivalents in Europe, Japan, Canada, and Australia in terms of the evaluation and approval of new drugs, notably COVID-19 vaccines. Although its approval times are increasing, raising doubts about Swissmedic’s continued place at the top table of global regulators, initiatives to address this issue are being rolled out and the organisation is also looking towards international collaboration to bolster its standing.
While Swissmedic has been fast to approve vaccines to counter the threat of COVID-19, the regulator has taken a different path to that of the EMA and FDA. As Interpharma’s René Buholzer points out, “Swissmedic has been very strong on the approval of COVID-19 vaccines and approved the Pfizer/BioNTech vaccine faster than the EMA. However, we are still awaiting approval for the AstraZeneca vaccine, which is dependent on the receipt of new trial data. The J&J vaccine, some of the research for which was conducted in Berne, has been approved but the FOPH has chosen not to purchase it. Therefore, Switzerland currently has three approved vaccines from Pfizer/BioNTech, Moderna, and J&J, the first two of which have been purchased, and has pre-ordered those from AstraZeneca, Novavax, and Curevac.”
Swissmedic has been very strong on the approval of COVID-19 vaccines and approved the Pfizer/BioNTech vaccine faster than the EMA
For Katrien de Vos, AstraZeneca’s country president in Switzerland, Swissmedic’s decision not to approve the AstraZeneca vaccine, which has been suspended among certain age groups in some geographies due to a risk of blood clotting, is understandable. “Swissmedic is an independent regulator that makes its own decisions,” she notes. “We respect the fact that they asked for additional evidence, specifically from a large randomized clinical trial. The company recently completed such a trial in the US, which will give Swissmedic a much larger data set to base their approval on.”
Looking to the future, Buholzer is hopeful that Swissmedic can take some of the lessons from vaccine approval and apply them to other areas. “Following the COVID-19 pandemic, we want to see Swissmedic’s rolling fast-track procedure be applied to other products of high medical need,” he exclaims. “Patient access to medicines and vaccines on the day of Swissmedic approval must be possible outside of a crisis. At the same time, it must not delay access in other categories, as has been the case in 2020.”
New active substances (NASs) took, on average, 520 days to be approved by Swissmedic in Switzerland in 2019, compared to 423 in Europe (EMA), 346 in Australia (TGA), 346 in Canada (Health Canada), 304 in Japan (PMDA), and just 243 in the USA (FDA).
While this is still a respectable showing for an independent mid-sized regulator, increasing delays are causing concern among industry stakeholders. The major issue seems to be in the labelling phase, as AbbVie’s Jon Helsdingen explains. “The basic challenge with Swissmedic is the fact that, while they are pretty quick to approve a certain treatment, the label discussions take a very long time. It can take up to 200 days in some cases, and then afterwards, we still have to go through the pricing and reimbursement discussions,” he states.
The basic challenge with Swissmedic is the fact that, while they are pretty quick to approve a certain treatment, the label discussions take a very long time
There does however seem to be a general appreciation of the work and progress that Swissmedic has made, as scienceindustries’ Stephan Mumenthaler notes. “Although there is still a way to go to achieve the final goal of positioning Swissmedic as a first-wave-agency, we are confident in seeing further progress here.” Interpharma’s Buholzer adds, “in term of drug approvals, Swissmedic is relatively swift and adaptive to new technology when factoring in the limited resources at their disposal. At the end of the day, it tends to be the second fastest regulatory agency globally in giving scientific assessment.”
Indeed, for numbers of approvals, Swissmedic is largely in line with other comparable regulatory bodies, bar the US FDA. Switzerland approved 28 NASs on a three-year moving average between 2010 and 2019, behind the US FDA (47), Japanese PMDA (33), and Health Canada (30), but ahead of the EMA (27) and the Australian TGA (25).
Moreover, Swissmedic is increasingly working with other mid-sized regulators in developed countries. As part of the ‘Access Consortium’ with the Australian TGA, Health Canada, HSA Singapore, and MHRA in the UK, Swissmedic aims to “build synergies and share knowledge amongst the regulatory authorities thereby enhancing the efficiency of regulatory systems,” according to a press statement. “Regulatory authorities face very similar challenges, such as increasing workload and increasing complexities in the medicinal applications that are being regulated, thus contributing to increasing pressure on available resources,” it adds. Pharmaceutical companies that submit applications to some or all of the five ‘Access’ countries will benefit from having their products evaluated for marketing in those countries simultaneously with reduced evaluation times.
Another way in which Swissmedic is establishing a more global footprint is via the Marketing Authorisation for Global Health Products (MAGHP) procedure, which aims to make the Swissmedic authorisation procedure and the scientific advice procedure accessible to representatives of regulatory authorities in low- and middle-income countries as well as to the World Health Organization (WHO).
The first such MAGHP approval was granted in May 2020 for Carbetocin Ferring, an injectable solution for the prevention of uterine haemorrhage due to postpartum uterine atony. Experts from the National Regulatory Authorities (NRAs) of Uganda, Kenya, Tanzania (mainland and Zanzibar), South Sudan, Nigeria, Democratic Republic of Congo, and Ethiopia participated in the procedure in order to grant fast-track approval to the treatment 90 days after application. Swissmedic will continue, at least in the initial pilot phase, to focus on Sub-Saharan Africa and on medicinal products for diseases that disproportionately affect patients in the region.
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