Swissmedic Annual Report 2018

80 Stakeholder management
• Regulatory Affairs round table for veterinary medicinal
products
A delegation from ten veterinary medicinal product
distributors headed by Scienceindustries met with
Swissmedic in Bern on 14 June 2018. There were
briefings and discussions on various topics, including the
HMV IV package and the changes it entails for this
stakeholder group.
• Information event for healthcare professionals
The first information event to be held under Swissmedic’s
revamped collaboration with associations and
organisations representing healthcare professionals took
place on 20 June 2018. The event focused on the
implementation of the revised Therapeutic Products Act
and associated therapeutic products ordinances.
External continuing training initiatives
and specialist presentations
Swissmedic is involved in the initial and continuing training
of therapeutic product specialists at tertiary education establishments,
conferences and expert meetings. Staff give
presentations on regulatory issues covering the entire spectrum
of Swissmedic’s service mandate. The main organisational
points covered by the presentations are published on
the Agency website.
International collaboration
Collaboration among authorisation and supervisory authorities
and with international organisations active in the medicinal
products and medical devices field is extremely important
for stakeholders, for Switzerland as a location, and
for Swissmedic. Efforts focus on exchanging information
throughout the medicinal product authorisation process,
market surveillance, and preparing new draft legislation
related to therapeutic products. For example, collaboration
with authorities from other countries and with international
institutions makes it easier to identify a therapeutic product’s
risks at an early stage and to initiate coordinated
measures.
International network
In recent years, Swissmedic has consistently networked
with partner authorities, in accordance with its strategy,
and has now concluded information exchange agreements
with virtually all internationally recognised therapeutic
products authorities that work to comparable standards.
Bilateral technical collaboration with partner authorities has
been stepped up and a system of benefit-driven information
sharing established.
International collaboration on therapeutic products regulation
does not only take place between individual authorities
at a bilateral level; increasingly it is occurring multilaterally
on different platforms. Swissmedic is heavily involved in the
commissions and working groups that have been set up by
these platforms where these are pertinent to the Agency’s
role.
Activities
Bilateral collaboration
• In September 2018, Swissmedic signed a Memorandum
of Understanding (MoU) with the Netherlands Medicines
Evaluation Board (MEB). Although not legally
binding, the MoU creates a formal basis for intensified
collaboration and for bilateral initiatives. Both Swissmedic
and the MEB will benefit from greater information
sharing. The two authorities are also involved in
global multilateral initiatives such as the International
Coalition of Medicines Regulatory Authorities (ICMRA).
Closer cooperation between Swissmedic and MEB therefore
benefits both parties and will help them accomplish
their mission efficiently.
• As in previous years, there was an exchange with the
Agency’s current partner authorities on certain operational
and strategic topics during 2018. For example, a
delegation from the German Federal Institute for Drugs
and Medical Devices (BfArM), led by the Institute’s
President, visited Swissmedic in January. The aim of the
visit was to pick up from the last meeting between the
two authorities in 2016 and to continue their dialogue
on authorisations, market monitoring, IT and international
activities. During the visit, there was also a
discussion on what effect the new MDR and IVDR
would have on the authorities’ activities.
In February, the Austrian Agency for Health and Food
Safety Ltd. (AGES) visited Swissmedic. Again, discussions
centred on the new medical devices regulation.