Abstract
This study addresses regulatory issues and problems associated with product development of biotechnological medical products and devices. Data were collected from interviews with Finnish companies, including: (1) 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 representatives were also interviewed.
Results show that, in Finland, developers, 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 promoted.
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