Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Swiss Überprüfungsverfahren – Similarities and differences to the EU Referral procedure ***

André Fischer (Abschlußjahr: 2017)

Summary
Language: English
Switzerland and the EU have both highly developed drug regulations which can be seen as comparable. Both have implemented numerous regulations and control mechanisms to secure that the quality, safety and efficacy of medicinal products placed on their market is guaranteed. In case of concerns procedures are in place to investigate the matter and if necessary issue appropriate measures.  
In the EU these procedures are known as Referrals and detailed documentation provided by the European Medicines Agency outlining any aspect of them is available.
In Switzerland a comparable procedure exists and is called Überprüfungsverfahren (UPV). However, opposite to the situation in the EU for this procedure hardly any guidance is available.
This discrepancy origins in the different philosophies of European legislation and Swiss legislation. While in the EU the focus is set on providing very detailed rulings and guidance covering any possible aspects of a topic Switzerland takes an opposite approach and only draws its rulings as minimal as possible providing maximum flexibility but as a consequence also poor guidance.
These contrary approaches are also reflected in the Referral and UPV. While the Referrals are clearly structured with defined timelines and specific requirements for each of the procedural steps an UPV seem to be a unique process with variable timelines and few constants only. When looking into details the biggest discrepancies between both is the lack of timelines and guidance for the UPV, the significantly higher interaction with the Swiss Authority Swissmedic during the procedure and the poor public communication of status and outcome of it. First three aspects assumingly derive from the fact that an EU Referral involves much more stakeholders from Authorities’ side than an UPV and so higher grade of organisation is deemed necessary. Later point is due to fact that current legislation in Switzerland has no specific focus on transparency related to drug regulation and only endorse publications in case of need for public safety. However, since the Swiss Therapeutical Act and its subsidiary regulations are currently under review and the restrictive transparency was identified as weakness an improvement is foreseeable.
Most remarkable difference is the already mentioned interactive character of the UPV. Since at least for safety related UPVs the case manager is in one person also the clinical reviewer and the author of the Decision the frequent interaction also vial phone or email not only compensates the lack of written guidance but also provides the Marketing Authorisation Holder of the medicinal product under investigation a better opportunity to present its position than in terms of a Referral.
Regarding similarities the procedural steps with an initial phase including investigation of the matter followed by issuing a draft assessment for discussion and later the binding Decision providing the company with a list of measures to be implemented is comparable. Also, since as mentioned at the beginning the standards of both drug regulatory environments are comparable the conclusions and thus the Decisions show also a high grade of similarity. Especially, since Swissmedic keeps strong focus on the progress of drug regulation in the EU and often adapts it.
From the above it can be concluded that both procedures are comparable and that the two major differences the UPV shows (lack of written guidance but high amount of interaction during the procedure) balance each other very well.  
Pages 68
Annexes: 6, Pages 4