Regulatory Aspects

Within the European Union, three possibilities of applying for a marketing authorization exist, the central procedure, the mutual recognition procedure, and the national procedure. The central procedure is compulsory for biotechnology-based pharmaceuticals, and the marketing authorization is granted by the European Medicines Evaluation Agency (EMEA) covering the EU member states. In the United States, regulatory control and review of biotechnology-based pharmaceuticals is administrated by the Center for Biologies Evaluation and Research (CBER) of the U.S. FDA. In contrast, a New Drug Application (NDA) is to be submitted for products to be approved by the Center for Drugs Evaluation and Research (CDER).

The purpose of the documentation for obtaining a marketing authorization is for the applicant to document a consistent quality, safety, and efficacy of the product, and to enable the regulatory agencies to evaluate that the risk-benefit ratio of the product is acceptable from a public health point of view. However, it is important to realize that the guidelines are guidelines and not legally binding documents. This means that the applicant must provide satisfactory documentation for the specific product, and the authorities may require additional documentation if considered necessary, even if this is not mentioned directly in a guideline.

Further information on European guidelines can be obtained on the EMEA homepage http://www.eudra.org/emea.html. The U.S. guideline can be found on the FDA homepage http://www.fda.gov/default.htm.

A special regulatory issue regarding biotechnology-based pharmaceuticals relates to the generic products or "follow-on protein products," as patent protections for a number of first-generation biotechnology-based protein products are about to expire. Because of the differences in complexity between small-molecule and follow-on protein products, the regulatory evaluation of biosimilarity for generic biotechnology-based proteins is a major challenge (180).

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