Full regulatory support to Applicants/Holders of Marketing Authorization for medicinal products in Switzerland
The Swiss pharmaceutical market is independent from the European Union, with distinct regulatory framework, legislations and regulatory authorities. With the third highest health care spending per capita, the 3bn Euros Swiss market is often regarded as a gate to the European marketplace. Pharmaceuticals are regulated by the Swiss Agency for Therapeutic Products (Swissmedic) whose requirements are quite close to those of the EMA. Noticeably, applicants for marketing authorization must hold a Pharmaceutical Establishment license granted by Swissmedic to be authorized to submit a MAA. In a mandatory private social health insurance system, price and reimbursement decisions are made by the Federal Office of Public Health (OFSP/BAG).
The VCLS Swiss team is established at the main Swiss Biotech hub, in Innovation Park on the EPFL campus in Lausanne.
- Gap analysis of existing data against Swissmedic requirements
- Adapt foreign applications to national requirements (e.g. conversion of US NDAs/BLAs to Swiss MAAs)
- Participate in meetings with Swissmedic (e.g. Scientific Advice, pre-submission meeting)
- Submit and manage Swiss MAAs – interactions during review process and life cycle management
- Represent foreign companies before Swiss authorities
- Act as applicant/holder for Marketing Authorization
- Obtain Orphan Drug Designation or fast track assessment on behalf of Sponsors
- Liaise with regional and federal competent authorities
- VCLS holds a valid Pharmaceutical Establishment Licenses (PEL) for drugs, biologics, cell- and tissue-based products
- Act as Qualified Person (“Responsable Technique”)
- Prepare and maintain Quality Management System on behalf of Sponsor