Statement for the German Federal Ministry of Health: On the experience of the research-based pharmaceutical companies with the Act on the Restructuring of the Pharmaceutical Market (AMNOG)
(Written inquiry of the German Federal Ministry of Health to the associations on February 14, 2013)
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vfa Press Release 033/2012 - Monday, November 19, 2012
Great potential!
The service sector is important, especially for the state of Berlin. Nonetheless, Berlin needs industry, and Berlin has industry. Added value and, as a result, jobs, high taxes and profits come from industry. In this respect, the pharmaceutical industry has a special significance for Berlin. It is one of the city’s few industrial growth centers and a growth engine within the region’s important health care sector.
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vfa Position Paper
„Nanobiotechnology/Nanomedicine”
By international comparison, Germany holds a strong position in the field of nanotechnology. Nanobiotechnology has the potential of opening up new or improved/earlier diagnostic or therapeutic opportunities for diseases that were previously insufficiently curable or completely incurable.
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vfa position on endpoints for oncological therapies
Due to the severity of oncological diseases, pivotal studies are subject to special methodological characteristics that must be taken into account during the selection of endpoints and the interpretation of the results.
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vfa Position Paper
"Qualified Person (QP)"
Over the past few years, the requirements for pharmaceutical production and control have fundamentally changed. For example, based on the implementation of the ICH Q8, Q9 and Q10 guidelines, more importance is assigned to process control and quality assurance. As a result, the final quality only serves the purpose of formal confirmation. Consequently, these changes also entail modifications in the requirements profile for the qualified person pursuant to Section 14 of the Medicinal Products Act/Art. 48 of Directive 2011/83/EC (hereafter referred to as Qualified Person/QP).
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vfa Press Release 006/2011 - Thursday, March 17, 2011
Birgit Fischer to be Director General of the vfa
Berlin (vfa). Effective May 1, 2011, Birgit Fischer will become Director General of the German Association of Research-Based Pharmaceutical Companies (vfa). At present, Ms. Fischer is Chair of the Management Board of Barmer GEK, Germany’s largest statutory health insurance fund.
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Executive Summary of the vfa's position on the Act for the Restructuring of the Pharmaceutical Market in Statutory Health Insurance (AMNOG)
From the vfa's perspective, the following key problems of the benefit assessment and the cost-benefit assessment are still not solved sufficiently:
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vfa/vfa bio Position Paper
Biosimilars
Biopharmaceuticals are manufactured with the help of living cells (e.g. hamster cells) or microorganisms (bacteria like E. coli or yeasts). In contrast to chemical-synthetic pharmaceuticals, their quality is essentially determined by the living organisms used and the manufacturing process. Even small modifications to the manufacturing process may lead to differences in the product that can change the drug's efficacy or tolerability in a sustained manner.
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vfa bio Press Release 001/2009 - Monday, April 27, 2009
Medical Biotechnology Grows by 9 Percent in Spite of Economic Crisis
Berlin (vfa bio). “Medical biotechnology is so far proving to be resistant to the economic crisis. The turnover of biopharmaceutical products in 2008 totaled 9 percent – twice the growth of the pharmaceutical market as a whole. With an unchanged number...
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Press Release 015/2009 - Wednesday, April 29, 2009
Churches and the Pharmaceutical Industry Urge More German Engagement for Health in Developing Countries
Berlin (GKKE / vfa). The Joint Conference Church and Development (GKKE) and the Association of Researching Pharmaceutical Companies (vfa) have advocated for increased efforts to improve health care in developing countries. In their joint statement released...
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Press Release 013/2009 - Thursday, April 23, 2009
Researching Pharmaceutical Companies to Come Out with 10 New Malaria Drugs
Berlin (vfa). Each year more than 800,000 people die worldwide from malaria infections. Children under 5 years of age in southern Africa are most at risk. The newest medications, provided by researching pharmaceutical companies under special conditions,...
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Press Release 012/2009 - Wednesday, April 1, 2009
Citizens Expect Further Reform
Berlin (vfa). Researching pharmaceutical companies commissioned Emnid to conduct a representative survey of the general opinion of health care policy in Germany. Here are the most significant findings, presented today at the polling institute by Klaus-Peter Schöppner.
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