Swissmedic Annual Report 2018

46 Market access l Inspections
Inspections by foreign authorities
in Switzerland
Swissmedic and the regional inspectorates operated by the
Cantons will, if required, accompany inspections of companies
in Switzerland by foreign authorities. In so doing, the
Swiss inspectors assume the role of representatives of the
Swiss inspections system.
Activities
• No problems occurred in connection with the implementation
of the new rules governing inspections by
foreign authorities in Switzerland that entered into force
on 1 January 2018. While Swissmedic is notified
beforehand of inspections by foreign authorities, such
inspections no longer require SECO approval. However,
foreign authorities are required to send a copy of their
inspection report to Swissmedic, a condition that was
largely respected.
• Foreign authorities carried out 82 GMP inspections at
pharmaceutical companies in Switzerland. The inspecting
authorities concerned were from the USA (39
inspections), Russia (21), Turkey (5), Mexico (3), Brazil
and Belarus (2 each), and Taiwan, Korea, Kazakhstan,
Yemen, Iran, Saudi Arabia, Libya, Colombia, the Gulf
Cooperation Council 1 and Eurasian Economic Union 2
(one each).
• Furthermore, Swissmedic provided specialist support
during one GVP inspection conducted in Switzerland by
BfArM, the German Federal Institute for Drugs and
Medical Devices.
Monitoring of the blood transfusion service
Swissmedic monitors Swiss blood transfusion activities by
means of inspections, licences, market monitoring of devices
and standardisation. The blood obtained from donors
and the labile blood products manufactured from it are
considered to be medicinal products in accordance with the
Therapeutic Products Act. It is mandatory to have a Swissmedic
licence for the collection of blood, the manufacturing
of labile blood products and the distribution of labile
blood products.
Activities
• To minimise the risk of transmitting the hepatitis E virus
(HEV) in blood transfusions, Swiss Transfusion SRC
adopted the recommendation of a working group of
which Swissmedic was a member, and started testing all
donated blood for HEV on 1 October 2018.
• Other risks were addressed by continually adapting
donor suitability criteria to the epidemiological situation
(e.g. in response to the spread of transmissible diseases
such as dengue fever and Chagas disease, or cases of
West Nile virus (WNV) and Chikungunya disease in
nearby countries).
• The special provisions applicable to blood and blood
products were also overhauled as part of the complete
revision of the Medicinal Products Licensing Ordinance
(MPLO).
• New provisions governing testing for the hepatitis B
virus, improving the information given to donors and
alignment with European GMP requirements have
applied since 1 January 2019.
A Inspections by foreign authorities in Switzerland
83 94 82
2018 2017
2016
1
GCC Golf Council Cooperation, including the members Saudi Arabia, Kuwait,
Oman, Qatar, Bahrain and the United Arab Emirates (UAE)
2
EAEU Eurasian Economic Union, including the members Armenia,
Belarus, Kazakhstan, Kyrgyzstan, Russia