Biotechnology Regulation: Views of the Authorities, Investors, and Product Developers in Finland
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Biotechnology Regulation: Views of the Authorities, Investors, and Product Developers in Finland
Outi Nieminen, MSc (Tech.) Research Scientist Leena Rahkamo, LicSc (Tech.) Research Scientist Katrina Nordstrom, PhD Professor. Laboratory of Biochemistry and Microbiology, Helsinki University of Technology, Espoo. Finland
Key Words Biotechnology; Regulatory; Biopharmaceuticals; Biophannacuetical product development Correspondence Address Ms. Outi Nieminen, Laboratory of Biochemistry and Microbiology, Department of Chemical Technology, Helsinki University of Technology, EO. Box 9400, FIN-02015-HUT, Finland.
This study addresses regulatory issues andproblems associated with product development of biotechnological medical products and devices. Data were collected from interviews with Finnish companies, including: (I) recent startup companies and more established companies that develop biopharmaceuticals and devices; (2) primary public and private investors in Finland, including venture and corporate capitalists; (3) private Finnish insurance companies; and (4) representatives of the Finnish national authorities. Two United States biotechnology companies, and European Agency for the Evaluation of Medicinal Products and U.S. Food and Drug Administration represen fatives were also interviewed. Results show that, in Finland, developers,
INTRODUCTION Biotechnology research continually opens opportunities for the development of new biopharmaceuticals and medical devices for human use. Consequently, integration of public healthcare and human welfare with the business of biotechnology is becoming a central challenge. However, the companies developing such products are often small and they may have insufficient knowledge of the possible regulatory aspects concerning such new products. Furthermore, due to the multitude of these products and the novelty of the field itself, regulatory approaches and guidelines are not necessarily well defined for these new products. The basic regulatory practice is based upon existing principles and guidelines for biotechnology and small chemical synthesized compounds. Inevitably, this leads to case-by-case evaluations based upon the latest scientific and technological developments and supportive data. Thus, the implementation of new techniques together
regulators, and investors have strong confidence in the success of Finnish biotechnology. However; according to this study, the regulatory definition of product categories of new biotechnological products is still evolving. This may lead to difficulties in achieving a definitive understanding of the exact regulatory procedures required to gain authorization to market these products and, thus, determining the information required to adequately describe early product development. Key issues are: scale-up of manufacture, product purification, safety aspects, and maintaining comparability with reference to possible changes in the manufacturing process. Improvements in dialogue in the development phases in terms of scientific advice should be pr
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