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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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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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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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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