Pharmacovigilance in Switzerland
How is it with drug safety system in European country? Follow our guide and you will be in the picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Swiss pharmacovigilance services:
LCPPV / QPPV in Switzerland
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Switzerland?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Switzerland is Swissmedic, officially known as the Swiss Agency for Therapeutic Products.
This agency is responsible for the authorization and supervision of drugs and medical products. Swissmedic is headquartered in Bern.
Useful insights about the authority website
CONTENT IN ENGLISH
The website has English version, and everything seems to be translated. Website is also accessible in French, German and Italian.
If you cannot find what you’re looking for, we suggest you to use the website in German and use translator, this way you have potentially much bigger chance to find what you’re looking for.
Interesting website sections related to pharmacovigilance
PHARMACOVIGILANCE SECTION
General information about Pharmacovigilance, Reporting adverse reactions and more. There is also FAQ on both Pharmacovigilance itself and Pharmacovigilance-Inspections (GVP, Good Pharmacovigilance Practices).
DOCUMENTS AND FORMS
Here you’ll find documents and forms regarding many areas, including Human medicinal product. Under Market surveillance there’s also pharmacovigilance section with form for reportind ADR and others.
MEDICINAL PRODUCT INFORMATION
On this page you’ll find a link that will redirect you to a database containing medicinal product information, there you can search by name, ATC code etc.
SCIENTIFIC PUBLICATIONS
This section highlights key articles related to Swissmedic, showcasing the important work being done in the realm of drug regulation and safety.
SWISSMEDIC VIDEOS
Short videos, created directly by Swissmedic, regarding many areas like Pharmacopeia, Reporting adverse reactions, Medicinal products or Swissmedic itself.
NEWSLETTER
There are five different types of their newsletter, each of them is listed separately. The most interesting for you will probably be one reagrding safety of medicines.
Other important institutions & industry groups
FEDERAL OFFICE OF PUBLIC HEALTH (FOPH)
The FOPH is the central authority for public health in Switzerland, responsible for developing national health policy and representing Swiss interests in international health organizations.
On their website you read their two periodicals (to see both you can’t use English verison of the website), called Spectra and BAG-Bulletin (only in German and French). Spectra provides information on prevention and health promotion, BAG-Bulletin is an official journal aimed at medical professionals, media representatives and interested parties. You can also read The Federal Council’s health policy strategy 2020–2030 and see how is it proceeding.
FOPH website: https://www.bag.admin.ch/bag/en/home.html
SWISS NATIONAL SCIENCE FOUNDATION (SNSF)
Although primarily a research funding body, the SNSF supports research initiatives that can impact public health policies and practices.
You can dive into their vast research section offering you many articles, findings and more, you can also subscribe to their newsletter to stay in the picture.
SNSF website: https://www.snf.ch/en
INTERPHARMA
Represents research-based pharmaceutical companies in Switzerland and advocates for an environment that fosters innovation and ensures high-quality healthcare.
We recommend to visit their section about Health system in Switzerland, where you can find more about its quality, sustainable funding etc., at the bottom there is also Interpharma’s annual report.
Interpharma website: https://www.interpharma.ch/?lang=en
scienceindustries
An umbrella organization for the chemical and pharmaceutical industries in Switzerland. It works with various partner associations to promote the interests of its members and address industry challenges.
On their website you can find many newsletters to subscribe, the most interesting for you will probably be “scienceindustries news”, regarding economic and socio-political topics and the positions of the chemical, pharmaceutical and life sciences industries, and “Current Biotechnology” regarding developments in the field of biotechnology (only in German), subscribtion can be done via form on the right sight.
scienceindustries website: https://www.scienceindustries.ch/
INTERGENERIKA
Represents generic drug manufacturers in Switzerland and advocates for policies that support the growth and sustainability of the generic pharmaceutical sector.
Visit their FAQ on Generics and Biosimilars and explore the differences between market for original drugs and market for generic drugs, website has only French and German version.
Intergenerika website: https://www.intergenerika.ch/
Some of the most important laws
Basic legislation
Therapeutic Products Act (TPA)
The TPA, also knows as Federal Act on Medicinal Products and Medical Devices, is the primary legislation governing the authorization and supervision of therapeutic products in Switzerland.
Guidelines
Good Pharmacovigilance Practice (GVP) Modules
The GVP modules, developed by the European Medicines Agency (EMA), provide guidelines on the implementation of pharmacovigilance activities.
Here you’ll find a list of guidance documents including “Guidance document Product information for human medicinal products” or “Guidance document Information of PSUR PBRER submission” and more.
Essential EU Legislation and EMA Guidlines
Switzerland is neither a member of the European Economic Area (EEA) or the EU itself, though it is a member of single market, meaning it does not have to follow pharmacovigilance legislation and guidelines by EMA (European Medicine Organization) exactly as other EU members but, in reality it does anyway.
To navigate through the European regulations, its is useful to know following:
EMA Pharmacovigilance System Manual
Directive 2001/83/EC and Regulation (EC) 726/2004
Commission Implementing Regulation (EU) 520/2012
Local pharmacovigilance specifics
Useful abbreviations & terms to know
If you want to study local materials about pharmacovigilance in Switzerland, following terms will be helpful for you to get familiar with:
EMA (European Medicine Organization)
→ Key part of the EU, dedicated to ensuring the safety and effectiveness of medicines.
ElViS portal (Electronic Vigilance System)
→ Pharmaceutical companies and healthcare professionals can report suspected adverse drug reactions directly via ElViS.
AIPS (Medicinal product information search platform)
→ Search platform with information for authorised human medicines.
VV (Verwaltungsverordnung) & WL (Wegleitung)
→ The published “Administrative Ordinances” (VV) are being replaced by “Guidance documents” (WL) – this relates to the Guidance documents.
UAW (Unerwünschten Arzneimittelwirkungen)
→ ADR / adverse drug reaction
Is LCPPV needed or is EU QPPV enough?
Yes, the Local Contact Person for Pharmacovigilance (LCPPV) is required in Switzerland, under certain conditions the EU QPPV can also serve as the LCPPV as specified in Therapeutic Products Act (TPA).
If you need a translation of those instructions or more information about LCPPV requirements in Europe in general, just check our free comprehensive guide available here.
How can be adverse events reported in Switzerland?
Reports can be submitted directly to Swissmedic via their online reporting platform, there are different forms for patients and health professionals.
Pharmaceutical companies and healthcare professionals are encouradge to reported electronically via the online ElViS.
Local medical journals to screen
Here are few examples of Swiss local literature that medical authorization holders should monitor:
SWISS MEDICAL WEEKLY
The official scientific publication of several Swiss medical societies, including the Swiss Society of General Internal Medicine.
It publishes original and review articles across all fields of medicine.
ISSN: 1424-3997
SWISSMEDIC JOURNAL
The official periodical of the Swiss Agency for Therapeutic Products, published in German and French.
It covers topics related to therapeutic products, including legal regulations, risks, and announcements about medicinal products.
ISSN: 2234-9456
REVUE MÉDICALE SUISSE
A prominent medical journal that publishes articles in French, it covers a wide range of medical topics, including clinical research and reviews.
ISSN: 1660-9379
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
SWISSMEDICAL ANNUAL REPORT
It provides a detailed overview of its activities, including statistics on drug approvals, clinical trials, and adverse drug reactions reported.
Scientific publications regarding pharmacovigilance
Did you know that while systemic drugs can have local effects on the eye, ophthalmology has one of the lowest reported rates of adverse drug reactions (ADRs)? This article dives into a fascinating study that aims to quantify these ADRs in Switzerland.
This article dives into the world of drug-induced liver injury (DILI) in Switzerland, using real-world data from the global pharmacovigilance database VigiBase™ to uncover critical insights. With a special focus on the emerging class of checkpoint inhibitors.
Do you need some help with putting the Swiss PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
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