Date post: | 17-Dec-2015 |
Category: |
Documents |
Upload: | arline-atkins |
View: | 213 times |
Download: | 0 times |
Registration and Harmonisation Registration and Harmonisation in the Area of Medical Products in the Area of Medical Products in Switzerlandin Switzerland
Swiss Russian Health ForumBasel, 10./11. September 2012
Dr. Petra DörrHead of Management Services & NetworkingMember of the Management BoardSwissmedic, Swiss Agency for Therapeutic Products
OverviewOverview
2
• Swissmedic: a short Introduction• Marketing Authorisation in Switzerland• International Cooperation and Harmonisation• Summary
Swissmedic: a short IntroductionSwissmedic: 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.
3
Swissmedic: a short IntroductionSwissmedic: 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)
4
Swissmedic: a short IntroductionSwissmedic: 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
5
Swissmedic: a short IntroductionSwissmedic: a short Introduction
6
Marketing Authorisation in Switzerland:Marketing Authorisation in Switzerland:Basics/Background 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
7
Marketing Authorisation in Switzerland:Marketing Authorisation in Switzerland:Approach 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 well-
recognised regulatory authorities, such as European Medicines Agency (EMA), US-Food and Drug Administration (US-FDA), etc.
8
Marketing Authorisation in Switzerland:Marketing Authorisation in Switzerland:Procedures Procedures
• Swissmedic currently applies two basic procedures • Regular marketing authorisation procedure• Fast-track procedure
• Criteria: treatment of life-threatening or chronically debilita-ting 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
9
Marketing Authorisation in Switzerland:Marketing Authorisation in Switzerland:Procedures Procedures
10
Sub
mis
sion
Val
idat
ion
(VA
L)co
mpl
eted
Doc
ume
nts
OK
List
of
Que
stio
ns(L
OQ
)
„App
rova
ble
lett
er“
(AL)
Dec
isio
n„V
erfü
gun
g“
VAL AD* Review phase I Response to AL LabellingResponse to LOQ Review phase II
Rec
eipt
of
resp
onse
to
LOQ
Rec
eipt
of
Res
pons
e to
AL
301010
max.10 12010060
max. 90 909050
max. 90 907020
Swissmedic times (Submission to decision): Regular Procedure: 330 calendar daysProcedure with advance notification (2013): 270 calendar daysFast-track procedure: 140 calendar days
Company time
Swissmedic-time
*AD = Amendment of documentation
Marketing Authorisation in Switzerland:Marketing Authorisation in Switzerland:Requirements 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)
11
International Cooperation & International Cooperation & HarmonisationHarmonisation
13
Why international cooperation?• 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
International Cooperation & International Cooperation & HarmonisationHarmonisation
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)
12
International Cooperation & International Cooperation & HarmonisationHarmonisation
14
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
FDASwissmedic
HSA Swiss-medic
XXX Swiss-medic
International Cooperation & International Cooperation & HarmonisationHarmonisation
15
Bilateral activities• Mutual Recognition Agreements (MRA):
• Canada, EU, EEA/EFTA
• Memoranda of Understanding (MOU): • 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)
International Cooperation & International Cooperation & HarmonisationHarmonisation
16
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
International Cooperation & International Cooperation & HarmonisationHarmonisation
17
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), …
SummarySummary
17
• 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