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The European system – Why? Complete single eu market for pharmaceuticals
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tarix | 02.10.2018 | ölçüsü | 0,5 Mb. | | #71927 |
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European Medicine Strategy and Liver Diseases/Hepatitis International Symposium Liver & Drugs 2008 – Viral Hepatitis – The Health Priority in EU, September 5, 2008, Bratislava, Slovak Republic Jan Mazag, CHMP Member, EMEA (London)
The European system – Why? Complete single EU market for pharmaceuticals Protect and promote public and animal health Same product information for professionals and for patients Benefit European R&D pharmaceutical industry Platform for discussion of public health issues at European level
The European system – How? “One European system: two procedures” - Centralised procedure
- Mutual recognition and decentralised procedures
EMEA is focal point of the centralised procedure Rapid and EU-wide authorisation after single evaluation No price or reimbursement issues
40 years of harmonisation 1965 - First Directive set out basic principles 1975 - First pharmaceutical testing Directive 1981 - Specific veterinary legislation adopted 1993 - Council Regulation No 2309/93 adopted 1995 - EMEA officially opens and new European system comes into operation 2001 - Commission proposes ‘Review’ package 2004 – Part of new legislation comes into force 2005 - New legislation came fully into force
A networking decentralised agency
EMEA and its Europartners Some 45 national competent authorities (dealing with human and veterinary medicines) Network of over 4,500 European experts
European experts’ network underpins the work of the scientific committees and working parties European experts work for EMEA independently of their nominating authority Scientific competence is guaranteed by their nominating authority, independence and integrity assured by public declaration of interests Services provided to EMEA on basis of a contract (conditions, quality and payment) €60m in 2008
EMEA and EU institutions EMEA adopts opinions on basis of scientific criteria, Commission takes decisions based on that opinion Commission must fully justify decision when it is not in accordance with EMEA opinion
EMEA – a dynamic agency 2001: Orphan medicines 2005: ‘Biosimilar’ and generic medicines 2005: Herbal medicines 2007: Paediatric medicines 2008/2009: Advanced therapies
EMEA priorities in 2008 Our core business Safety monitoring of medicines for human and veterinary use Stimulation of innovation The European medicines network Transparency, communication and provision of information International regulatory activities
Vaccines for preventive use Problem of immunogenicity of vaccines Effectivity of vaccines content of organomercuric preservative mainly used in vaccines (from 1999)
HBV actual guidelines Guideline on the core SPC for human plasma derived hepatitis –B immunoglobulin for intramuscular use (CHMP/BPWG/4222/02) Actual from November 2006 Guideline on the core SPC for human plasma derived hepatitis-B immunoglobulin for intravenous use (CHMP/BPWG/4207/02 Actual from November 2006 Coordination role in harmonisation of SPC for products used in immunopropfylaxis of HBV in non- immunised patients
HCV Infection – European perspective HCV infection is the most common infection causing chronic liver disease. Prevalence varies by geographic region (about 0.5% in Northern countries, 2% and higher in Mediterranean countries / Eastern Europe). HCV of genotype 1(GT 1) is the predominant genotype. 30% (-50%) of HIV-infected patients are co-infected with HCV. After about 20 years, around 20–30% of chronic carriers progress to cirrhosis, 5–10% have end stage liver disease and 4–8% die of liver-related causes. In patients with cirrhosis, the 5-year risk of hepatic decompensation is around 15-20% and that of hepatocellular carcinoma around 10%. The current standard-of-care (SOC) is pegylated interferon-alpha 2a or 2b and ribavirin. With SOC, around 70-85% of patients infected with HCV genotype 2 and 3 achieve SVR after a 6-month treatment course. In contrast, only half of patients infected with HCV genotype 1 and 4 reach SVR despite treatment for one year.
Medicinal products for treatment of Hepatitis (1/2)
Medicinal products for treatment of Hepatitis (2/2)
EMEA/CHMP Guidelines Clinical Evaluation of Medicinal Products intended for Treatment of Hepatitis B (CPMP/EWP/6172/03) Clinical Evaluation of Direct Acting Antiviral Agents intended for Treatment of Chronic Hepatitis C (CHMP/EWP/30039/08) - Release for consultation Apr 2008
Draft HCV Guideline (1/2) Scope Guidance on the design of exploratory and confirmatory clinical studies for the evaluation of direct-acting anti-HCV compounds as add-on to SOC in different target populations. Specifically addressing the constraints caused by the high mutation rate of HCV. Focused on direct-acting anti-HCV compounds.
Draft HCV Guideline (2/2)
Published Draft http://www.emea.europa.eu/pdfs/human/ewp/3003908en.pdf
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