Registration and Harmonisation
in the Area of Medical Products
in Switzerland
Swiss Russian Health Forum
Basel, 10./11. September 2012
Dr. Petra Dörr
Head of Management Services & Networking
Member of the Management Board
Swissmedic, Swiss Agency for Therapeutic Products
Overview
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Swissmedic: a short Introduction
Marketing Authorisation in Switzerland
International Cooperation and Harmonisation
Summary
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Swissmedic: a short Introduction
Mission
Our competence – for your trust in therapeutic products
We are the Swiss agency for the authorisation and supervision
of therapeutic products. We fulfil our legal mandate and work
with partner authorities on a national and international basis.
We endeavour to ensure that authorised therapeutic products
are of high quality, effective and safe. By doing so, we make a
considerable contribution towards protecting the health of
humans and animals, and we also participate in safeguarding
Switzerland as a location for industry and research.
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Swissmedic: a short Introduction
• Established in January 2002 as the first Federal authority on
therapeutic products along with the coming into force of the Act
on Therapeutic Products
• Prior to 2002, regulation of medicinal products was a cantonal
responsibility
• Scope of products
• Medicinal products for human and veterinary use (Chemical,
biotechnology, biologic, stable blood products, transplant products,
traditional and herbal medicines, …)
• Medical devices (based on EU system, Notified Bodies and CE-marking)
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Swissmedic: a short Introduction
Areas of responsibility
• Marketing authorisation (medicinal products)
• Market surveillance (medicinal products and medical devices)
• Inspections, licenses
• Control of narcotics
• Laboratory controls / Official Medicines Control Laboratory
• Enforcement / Criminal penalisation
• Drafting of laws and standards
• Provision of information on therapeutic products
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Swissmedic: a short Introduction
Key figures
• Staff:
360 full-time equivalents
430 people
• Budget:
80 Mio. CHF
• Federal contribution:
≈ 20%
• Fees:
≈ 80%
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Marketing Authorisation in Switzerland:
Basics/Background
National marketing authorisation
• Medicinal products have to be authorised by Swissmedic
before they can be marketed in Switzerland
• Switzerland – not being a member of EU/EEA – does not
participate in EU-marketing authorisation procedures
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Marketing Authorisation in Switzerland:
Approach
• Applications for innovative medicinal products, e.g. with new
active substances
• Swissmedic conducts its own assessment (as a general rule)
• Applications for non-innovative medicinal products, e.g. generics/
known active substances
• Swissmedic should consider assessments of other wellrecognised regulatory authorities, such as European
Medicines Agency (EMA), US-Food and Drug Administration
(US-FDA), etc.
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Marketing Authorisation in Switzerland:
Procedures
• Swissmedic currently applies two basic procedures
• Regular marketing authorisation procedure
• Fast-track procedure
• Criteria: treatment of life-threatening or chronically debilitating illness, no or no sufficient treatment options available,
high expected therapeutic benefit (“unmet medical need”)
• In 2013, an additional route will become available: the procedure
with advance notification for innovative medicines, not fulfilling
the criteria for a fast-track procedure
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Marketing Authorisation in Switzerland:
Procedures
Company time
VAL
30
10
10
AD*
max.10
Review phase I
Response to LOQ
Review phase II
120
100
60
max. 90
90
90
50
*AD = Amendment
of documentation
Response to AL
max. 90
Swissmedic times (Submission to decision):
Regular Procedure:
Procedure with advance notification (2013):
Fast-track procedure:
Decision
„Verfügung“
Receipt of
Response to AL
„Approvable
letter“ (AL)
Receipt of
response to LOQ
List of Questions
(LOQ)
Documents OK
Submission
Validation (VAL)
completed
Swissmedic-time
Labelling
90
70
20
330 calendar days
270 calendar days
140 calendar days
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Marketing Authorisation in Switzerland:
Requirements
• Documentation
• Common Technical Document (International Conference on
Harmonisation; ICH CTD)
• “State of the Art”
• ICH Guidelines
• EMA/FDA technical guidelines
• Specifics
• Labelling (2-3 languages)
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International Cooperation &
Harmonisation
Why international cooperation?
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Implementation of international treaties
Ensuring drug safety/mutual benefit from early risk-communication
Building mutual trust
Increasing efficiency/create synergies
Harmonisation of requirements
Reduction of technical barriers to trade
Maintaining international reputation
Motivation of staff
 Need to network globally on an agency level as regulated
industry is also operating globally
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International Cooperation &
Harmonisation
Swissmedic: Basis for international cooperation
• Act on Therapeutic Products (Art. 64 ATC: International
Administrative Assistance
• Mandate (Federal Council; four years; strategic goals)
• Service Agreement (Department of the Interior; objectives on
an annual basis)
• Strategy paper on national and international cooperation
(approved by the Council of the Institute in May 2008)
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International Cooperation &
Harmonisation
FDA
XXX
HSA
Swissmedic
Swissmedic
Swissmedic
Swissmedic Strategy
• Prioritisation/selection: we are small - we have to focus on key
partners/activities
• … towards global leading agencies: consideration/reliance, staff
and information exchange, peer review
• … towards partner agencies: consideration/reliance, staff and
information exchange, peer review, towards work sharing
• … towards developing agencies: provision of information/training
• Support of WHO activities
• Harmonisation of requirements: collaboration in international
standard setting organisations
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International Cooperation &
Harmonisation
Bilateral activities
• Mutual Recognition Agreements (MRA):
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Canada, EU, EEA/EFTA
• Memoranda of Understanding (MOU):
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Food and Drug Administration, USA (2003)
Health Products and Food Branch, Canada (2006)
Therapeutic Goods Administration, Australia (2006)
Health Sciences Authority, Singapore (2008)
Medsafe, New Zealand (2009)
Ministry of Health, Labour and Welfare/Pharmaceuticals and Medical Devices
Agency, Japan (2010)
Irish Medicines Board, Ireland (2011)
Paul-Ehrlich Institut, Germany (2012)
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International Cooperation &
Harmonisation
Multilateral activities
• International Regulators Consortium (Australia, Canada,
Singapore, Switzerland)
• World Health Organization:
• Pre-Qualification, trainings, Blood Regulators Network,
Paediatric medicines Regulators Network
• PFIPC (Permanent Forum on International Pharmaceutical
Crime)
• Council of Europe/European Pharmacopoeia
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International Cooperation &
Harmonisation
Harmonisation & standard setting organisations
• International Conference on Harmonisation (ICH, www.ich.org)
• Harmonised requirements for the registration of medicinal
products for human use
• Global Harmonisation Task Force (GHTF, www.ghtf.org)
• Harmonised requirements for medical devices
• Pharmaceutical Inspection Cooperation Scheme (PIC/S), World
Health Organisation (WHO), Organisation for Economic
Cooperation and Development (OECD), …
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Summary
• Swissmedic’s mandate comprises medicinal products and
medical devices and is based on the Act on Therapeutic Products
• Swissmedic does not participate in EU-marketing authorisation
procedures but grants national Swiss marketing authorisations
• Swissmedic conducts an independent assessment for innovative
medicines
• International cooperation between regulators is paramount, as
industry is also globalised
• International cooperation has to be focussed and tailored to the
specific national situation
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Thank you for your attention…
Questions?
Dr. Petra Dörr
Petra.doerr@swissmedic.ch
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