Swissmedic offers various regulatory procedures for authorisation and variation applications relating to medicinal products, including vaccines, used to prevent and combat COVID-19. Companies submitting corresponding applications during the current pandemic are given maximum flexibility so that Swissmedic is able to fast-track its decisions and patients have access to safe, effective and high-quality medicines as quickly as possible.
Publication of new guidance document on procedures for authorising medicinal products during a pandemic
The Guidance document Authorisation procedures for Covid-19 medicinal products during a pandemic describes the various scientific advice options and the regulatory procedures for authorisation and variation applications for COVID-19 medicines.
For pandemic medicines, Swissmedic provides an option for the gradual submission of the authorisation application ("Rolling Submission"). This allows pharmaceutical companies to submit applications for COVID-19 medicinal products even before development is concluded and complete documentation is available.
Furthermore, Swissmedic has adapted the requirements applicable to product information and packaging texts for medicinal products used to prevent and combat the new coronavirus SARS-CoV-2. The guidance document also includes important questions and answers (link to FAQs).
The guidance document enters into force on the date of publication and will apply immediately to all incoming applications connected with the COVID-19 pandemic.
Pre-Submission and Scientific Advice Meetings
Swissmedic offers the option of advice meetings to research groups and the pharmaceutical industry with the aim of supporting development programmes in an efficient and targeted manner, discussing scientific data and fast-tracking authorisation applications for COVID-19 medicinal products. These measures are designed to ensure that patients have the earliest possible access to safe, effective and high-quality medicines used to prevent and combat the new coronavirus.
Swissmedic also works in close scientific collaboration with expert groups and with national and international authorities so that it can fast-track authorisation procedures and react quickly to new developments.