Swissmedic - Swiss Agency for Therapeutic Products

Swissmedic – Swiss Agency for Therapeutic Products

Clinical trials
– Submission of applications
– Clinical trials on medicinal products
– Temporary authorisation to use medicinal products in accordance with Article 9b para. 1 TPA
– Fees

Licensing
– Authorisations
– Special authorisation
– Microbiological Laboratories

Authorisations
– Information
– New authorisations
– Real World Evidence (RWE)
– Access Consortium work-sharing
– Project Orbis initiative
– SwissPAR
– Summary report on authorisation
– Human Medicines Expert Committee (HMEC)
– Expert Commission for Radiopharmaceuticals (ECRP)
– Roundtable Regulatory Affairs
– Publication platform

Special categories
– Authorised narcotics
– Blood and blood components
– Medicines for children
– Advanced Therapy Medicinal Products
– Controlled substances according to Art. 21 TPA

Combination products
– Information
– Questions and answers

Questions on delimitation

Market surveillance
– Pharmacovigilance
– Topics
– Risk Management (Signalmanagement, PSURs, RMPs/RMP summaries)
– Healthcare Professional Communications
– Haemovigilance
– Quality defects and batch recalls
– Out-of-Stock
– Illegal drug imports
– Advertising of medicinal products