For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into effect, furthering one of the regulator’s long-standing objectives of stepping up international collaboration.
Landmark WHO Listing
SwissMedic gained global recognition of its standards and practices last year when it became one of the first three WHO-listed regulatory authorities in the world, along with Singapore’s Health Sciences Authority (HSA) and South Korea’s Ministry of Food and Drug Safety (MFDS). To achieve the WHO listing, a system the organisation devised to designate and publicly list regulatory authorities “operating at an advanced level of performance to be globally recognised,” SwissMedic had to demonstrate its compliance with all of the WHO’s indicators and requirements.
“This achievement is the result of investment by the Governments of the Republic of Korea, Singapore and Switzerland in the strengthening of their regulatory systems and reaffirms the collaboration between WHO and the three Governments in promoting confidence, trust and further reliance on authorities that have attained this global recognition, through the transparent and evidence-based pathway for designating and listing of WLAs”, said Dr Yukiko Nakatani Assistant Director-General for Access to Medicines and Health Product
Switzerland-US Partnership
As a part of the agency’s ongoing efforts to foment international collaboration and its long-standing cooperation with the US Food and Drug Administration (FDA), in 2023, SwissMedic signed a Good Manufacturing Practice (GMP) Mutual Recognition Agreement (MRA) with the US Food and Drug Administration (FDA).
To reach the agreement, under which both countries accept inspections carried out by the other country’s regulatory authority, the two partner agencies scrutinised each other’s processes for monitoring medicinal product manufacturers in their respective countries and found them to be comparable.
Within the terms of the MRA, both SwissMedic and the FDA will be able to check with the partner authority to find out whether a production site has already been inspected and if so the partner authority will provide the necessary GMP documentation.
Updates to Temporary Authorisation and APIs
Beyond these milestones, the Swiss agency has also updated its guidance both for temporary authorisations and APIs, improving the application process for temporary authorisations and better defining its directives relating to APIs.
The regulator optimised its temporary authorisations policy, specifying that to qualify for temporary authorisation, no alternative authorised product can be available in Switzerland and that based on the result of the assessment of the documentation submitted, differing processes would be employed. The agency also put forward an Accelerated Application Hearing (AAA).
For active pharmaceutical ingredients (API), the agency also updated its guidelines and reworked its definition of what can be acceptable as a known active ingredient (KAS) to include complex APIs. “Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure (or with a formulation of this active pharmaceutical ingredient that is complex and heterogeneous) may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation),” said Swissmedic. “However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterization.”
SwissMedic 2023 DrugApprovals:
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