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EEC policy for regulation of biotechnology products
Author(s) -
Scheibner Eckardt,
Bass Rolf
Publication year - 1988
Publication title -
journal of chemical technology and biotechnology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 117
eISSN - 1097-4660
pISSN - 0268-2575
DOI - 10.1002/jctb.280430414
Subject(s) - directive , product (mathematics) , quality (philosophy) , structuring , authorization , business , test (biology) , risk analysis (engineering) , process management , good manufacturing practice , european union , microbiology and biotechnology , computer science , marketing , international trade , biology , mathematics , computer security , paleontology , philosophy , geometry , epistemology , finance , programming language , supply chain
Abstract The most important regulative EEC decisions concerning biotechnology products are the creation of the ‘concertation procedure’ for EEC‐wide registration (Council Directive 87/22/EEC), and the authorization of the CPMP to adapt test requirements according to technical progress (Council Directive 87/19/EEC). Test requirements (Notes to Applicants) on pharmaceutical quality (MAB's, rDNA‐derived products‐cell substrates in preparation) and on preclinical safety testing have been published. The pre‐clinical notes to applicants seek to overcome the current case‐by‐case procedure, which is unsatisfactory both for industry and regulatory authorities, by structuring the heterogeneous variety of products into product related test schemes, thus giving better orientation for applicants for marketing authorizations. There is a horizontal structure (4 product groups: hormones, cytokines, regulatory peptides/blood products, MAB/immunizing agents) and a vertical structure (depending on the biochemical deviation from the naturally occurring product). Allocation of a given product horizontally will determine the strategy, and vertically the depth of testing. Additional remarks concerning methods allow for deviations from test schemes developed for chemical products, in relation to species‐restricted lack of response and immunotolerance. The concept of deriving test schemes from product characteristics has proved successful, but is subject to further improvement (e.g. including as additional structuring elements the generic familiarity, and use‐related criteria spanning from substitution to pharmacodynamic effectuation with supraphysiological dose regimes), and making better use of the present knowledge of sera, vaccines and other biologicals (and their regulation), thus facilitating easier planning and performance of relevant pre‐clinical safety testing.