The Swiss pharmaceutical market is independent of the European Union (EU), with the distinct regulatory framework, legislations, and regulatory authorities. With the 3rd highest health care spending per capita, the 3bn Euros Swiss market is often regarded as a gate to the European marketplace
Obtaining the registration of a medicinal product in the EU or the CE Marking for a medical device is a major objective for any company wishing to commercialize their product in Europe. Although Switzerland is not part of the EU, the Swiss competent authority (Swissmedic) does follow all ICH and EMA’s guidelines and has adopted most EU Regulations regarding the registration of medicinal products.
Switzerland has signed a Mutual Recognition Agreement (MRA) with the EU and, therefore, is fully aligned with the European regulation for Medical Device (Directive 93/42/EEC), active implantable medical devices (Directive 90/385/EEC) and In Vitro Medical Device (Directive 98/79/EC) currently in place. With the European regulatory environment evolving in the coming years, Switzerland is revising its medical devices legislation (Medical device Ordinance) in close alignment to the new and more stringent EU rules which are coming into effect in May 2021 for the Medical Device Regulation (2017/745) and in May 2022 for IVD regulation (2017/746). VCLS is closely monitoring Swissmedic updates on MRA and Medical Device Ordinance.
We provide full strategic and operational support to bring medicinal products, including Medical Devices, Software as Medical Devices, IVDs, and Companion Diagnostics products to the Swiss market according to the national requirements by setting up a local affiliate, building Swiss QMS, and maintaining licenses post-approval (LCM).
Full regulatory support to Applicants/Holders of Marketing Authorization in Switzerland
The principles and standards which form the basis of an EU approval are equally shared by Swissmedic, whose requirements are quite close to those of the EMA. For this reason, it is expected for foreign companies to apply for registration in Switzerland in parallel to a European registration procedure or immediately after getting an EU approval for a medicinal product.
As for the EU, any applicant for a Marketing Authorization (MA) must be established locally, i.e. having a legal entity in Switzerland. We provide support to our Clients who are not yet established in Switzerland and act as local Sponsors on their behalf for Clinical Trial Applications as well as Applicant for Marketing Authorization. In the latter case, post-approval, we transfer the MA to our Client’s Swiss-based affiliate incorporated in the meantime or to a local commercial partner, depending on the strategy adopted by our Client.
- Perform gap analysis of existing data against Swissmedic requirements
- Adapt foreign applications to national Swiss requirements (e.g. conversion of US NDAs/BLAs or EU MAAs to Swiss MAAs)
- Participate in meetings with Swissmedic (e.g. Scientific Advice, pre-submission meeting)
- Submit and manage Swiss MAAs and interact with Case Managers during the review process
- Maintain Swiss MA (assess the impact of Change Controls on Swiss MAs, prepare Variations package, and more generally take care of all Life Cycle Management activities)
Learn more about our Regulatory Strategy and Submission capabilities.
A complete clinical service from Clinical Trial Application (CTA) to Clinical Trial Management in Switzerland
The Swiss regulatory framework applying to clinical trials draws from the international EU/EEA regulations and guidelines, with its own specificities similar to other EU/EEA countries. To conduct a clinical trial in Switzerland, an application compliant to Swiss requirements must be submitted to Swissmedic and to the Swiss ethics committees concerned.
As for the EU/EEA, a sponsor not based in Switzerland must appoint a representative established in Switzerland. VCLS can act as the Swiss representative for sponsors, under a number of conditions.
VCLS has extensive experience with clinical trial applications to Swissmedic and Swiss ethics committees, as well as the associated regulatory maintenance and national registry (SNCTP) management
- Draft and/or review patient-centric Protocol and CTA supportive documentation against Swissmedic requirements
- Adapt core-CTA applications to national Swiss requirements (e.g. conversion of a US IND or an EU CTA to a Swiss CTA)
- Submit and manage Swiss CTAs and interact with Swissmedic and the Swiss ethics committees during the review process
- Maintain Swiss CTA (assess the impact of amendments on Swiss CTAs, prepare amendment package and other notifications)
In addition to clinical trial submissions, VCLS supports sponsors with the operational management of their studies:
- Study planning, design, preparation, conduct, and data collection
- Select, manage, and coordinate various stakeholders
- Clinical safety activities (expedited and period safety reporting in Switzerland in the frame of the study)
- Conduct a cohort and named patient compassionate use programs in Switzerland
Learn more about our Clinical Trial solutions.
Effective communication with Swiss Authorities
- Represent foreign companies before Swiss regional/cantonal authorities
- Represent foreign companies and liaise with federal authorities, mainly Swissmedic (Swiss Medicines Agency) and OFSP/BAG (Swiss HTA body)
- Act as CTA local Sponsor (Swiss Legal representative) for foreign sponsors
- Obtain Orphan Drug Designation or fast track assessment on behalf of foreign Sponsors
- Act as Applicant for Swiss MAAs
Quality Assurance Services
Swissmedic granted VCLS Swiss office a pharmaceutical establishment License, also known as a Wholesale Distribution Authorization (WDA). This authorization, mandatory to act as MA Applicant, means that a Quality Management System is in place under the supervision of VCLS Qualified Person (QP), also known as a local Responsible Person (RP)
- Prepare and maintain a Quality Management System (QMS) on behalf of Client
- Act as interim Qualified Person (QP)/Responsible Person (RP) on VCLS’ pharmaceutical establishment license (WDA) before the MAH transfer to Client’s Swiss entity or local commercial partner
- Act as contract QP/RP (Principal and/or Deputy role)