Swiss Agency for Therapeutic Products
SwissMedic is the central Swiss supervisory authority for therapeutic products. It is a public service organization of the federal government with headquarters in Bern. It is independent in its organization and management and has its own separate budget. SwissMedic is linked to the Federal Department of Home Affairs (FDHA). The Agency Council is its highest body and represents SwissMedic in contacts with the FDHA and the Federal Council (the Swiss government).
In September 2003, FDA and SwissMedic signed a memorandum of understanding (MOU) intended to enhance and strengthen communication and public health promotion and protection cooperative activities related to the regulation of human or animal pharmaceutical products and human medical devices in Switzerland and the United States. Information that may be shared includes, but is not limited to:
- drafts of pending laws, regulations, guidance documents, procedures, and other technical documents;
- post-marketing data and information that could have an impact on the public health, such as pharmacovigilance data or information about impending regulatory actions;
- information on quality defects or product recalls of human or animal pharmaceutical products or medical devices;
- information contained in or related to marketing or investigational applications for human or animal pharmaceutical products or medical devices, including the various discipline reviews;
- inspection reports and product sample test results such as those describing the conformity of a human or animal pharmaceutical product or medical device, or a facility, that manufactures these products, with applicable regulatory requirements;
- information on facilities registered or authorized in each Participant's country that then market product to the other Participant's country;
- information related to import refusals for reasons related to the safety, quality, or integrity of the shipment.
Information exchanged under the MOU may include non-public information exempt from public disclosure under the laws and regulations of Switzerland or the United States. Information that is not appropriate for public dissemination will be shared according to the procedures and policies of the Participants as permitted by their respective laws. FDA/HHS and SwissMedic are not able to share trade secret information without the consent of the owner of the information. With regard to any other types of non-public information that may be provided to SwissMedic by FDA/HHS or to FDA/HHS by SwissMedic, such transmissions will be made in accordance with the specific signed confidentiality commitments and other requirements of the Participants.