The European Commission, European Medicines Agency (EMA), Swiss Federal Department of Home Affairs (FDHA) and the Swiss Agency for Therapeutic Products (Swissmedic) have had confidentiality arrangements in place since 2015, allowing for the exchange of confidential information as part of their regulatory and scientific processes. The European Union (EU) and Switzerland also have a mutual recognition agreement (MRA) in place on good manufacturing practice (GMP) compliance.
The European Commission, EMA, FDHA and Swissmedic signed a confidentiality arrangement in 2015. It is valid for five years and may be renewed.
The confidential information that EMA and Swissmedic can share includes:
- all legislation and guidance documents, including non-final documents;
- post-authorisation pharmacovigilance data, particularly in relation to adverse drug reactions, as well as safety concerns arising from periodic safety update reports and post-authorisation obligations and commitments;
- applications for scientific advice, orphan designation, marketing authorisation or post-authorisation activities of significant public health interest;
- applications for agreement of paediatric investigation plans;
- Pharmacovigilance and good clinical practice (GCP) reports.
Exchange of letters
- Administrative arrangements to exchange non-public information on medicinal products between DG SANTE-EMA and Swiss FDHA-Swissmedic (22/7/2015)
- Reply to the administrative arrangements to exchange non-public information on medicinal products between DG SANTE-EMA and Swiss FDHA-Swissmedic (22/7/2015)
MRA on GMP compliance
- rely on each other's GMP inspections of manufacturers in their respective territories;
- waive batch testing of products on entry into their territories;
- share information on inspections and quality defects.
For more information on MRAs and the scope of the EU-Switzerland MRA, see Mutual recognition agreements.
Cooperation on H1N1 pandemic
EMA and Swissmedic first entered into a confidentiality arranegment in 2010, to allow the exchange of non-public information on medicines and vaccines under development against the H1N1 influenza pandemic. The H1N1 medicines and vaccines developed in this period remain authorised in the EU and in Switzerland. EMA and Swissmedic extended this arrangement twice in 2011 and in 2012.
Exchange of letters
- Extension of arrangement for shared non-public information regarding the influenza A (H1N1) pandemic between the EMA and the Swiss Agency for Therapeutic Products, Swissmedic (3/2/2012)
- Extension of arrangement for shared non-public information regarding the influenza A (H1N1) pandemic between the EMA and the Swiss Agency for Therapeutic Products, Swissmedic (14/2/2011)
- Letter from EMA: Arrangement for shared non-public information regarding influenza A (H1N1) pandemic with Swissmedic (15/2/2010)
- Letter from Swissmedic: Arrangement for shared non-public information regarding influenza A (H1N1) pandemic (15/2/2010)