SWITZERLAND Law and Practice Contributed by: Oliver Brupbacher, Markus Schott, Markus Wang, Djamila Batache and Christine Schweikard, Bär & Karrer AG
4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes Medicinal Products For the approval of a human medicinal product, a fast track procedure may be conducted. Unlike the standard procedure, the fast track procedure requires a previously approved request for the implementation of this procedure. Once such a request is received, Swissmedic will determine within 30 days whether the criteria for the fast track procedure are met (Article 7 of the OMP) (see Section 5.3 of Swissmedic guidance docu- ment “Fast-Track Authorisation Procedure” ). To qualify for a fast track authorisation procedure for a human medicinal product, the following cri- teria must be met. • The medicinal product must provide prom- ising prevention or treatment for a severe, disabling, or life-threatening disease (Article 7 lit a of the OMP). • No currently authorised medicinal product exists for the condition, or existing treat- ments are unsatisfactory (Article 7 lit b of the OMP). Authorised medicinal products may be deemed unsatisfactory owing to vari- ous factors, including limited effectiveness, safety concerns, or the absence of an estab- lished standard treatment (see Section 5.1 of Swissmedic guidance document “Fast-Track Authorisation Procedure” ). • The new medicinal product must offer a sig- nificant improvement based on new clinical evidence. To provide a comparative basis, applicants must evaluate efficacy and safety data against existing authorised medicinal products available in Switzerland (see Sec- tion 5.1.c of Swissmedic guidance document “Fast-Track Authorisation Procedure” ).
report to Swissmedic all serious incidents as well as all field safety corrective actions that are undertaken in Switzerland (Article 66 of the MedDO and Article 59 of the IvDO). 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices Authorities must, in principle, treat all data col- lected within the framework of the TPA and its implementing regulations as confidential, includ- ing all data communicated to the authorities in the context of a marketing authorisation appli- cation (Article 62 of the TPA). Granted market- ing authorisations for medicinal products are published in the monthly Swissmedic Journal , together with essential information about the medicinal product. Swissmedic publishes an assessment report (SwissPAR) for all medicinal products with a new API – as well as for trans- plant products – for which a decision to approve or reject authorisation has been issued. The SwissPAR includes the evaluation results of the application for new authorisation or additional indication of a medicinal product, but not the applicant’s commercial or manufacturing secrets or personal data. Regarding medical devices, the conformity assessment procedures by Swiss or European assessment bodies are not accessible to third parties. The successful completion of a conform- ity assessment is made public together with the issuance of the declaration of conformity for the respective product (Article 90 lit f of the MedDO).
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