Biological medicinal products
Biotechnological products are the most rapidly growing group of medicinal products. Based on clinical trials and scientific advice provided by the authorities, it is estimated that today as many as one third of all medicinal products being developed are biotechnological medicinal products.
Vaccines are the single most important group of medicinal products from the public health perspective. They are also used in the prevention of animal diseases. In health care services blood products occupy a key position. Some blood products are controlled by the medicinal product legislation and others by blood transfusion regulations. Today’s biotechnological medicinal products are mainly manufactured by recombinant DNA technology. They play an important role in the treatment of diabetes, cancer diseases, rheumatoid arthritis and other autoimmune diseases. The most recent arrivals in the group of biotechnological medicinal products are advanced therapies, i.e. gene and cell therapy.
Regulation of biological medicinal products
Control of biological medicinal products has always held a special position in EU legislation. The EU standards for products containing blood and other human tissue are recorded in the directives approved in 2003 and 2004, whose implementation will start in the near future. The authorities have the right, when they so require, to investigate batches of vaccines or plasma-derived blood products before they are released for clinical use. Biotechnological products are subject to the European Union’s centralised marketing authorisation procedure, which is co-ordinated by the European Agency for the Evaluation of Medicinal Products (EMEA) in London.
Biological medicinal products and NAMThe National Agency for Medicines lists the safety of biological products as one of its strategic areas of focus. Together with children’s medicines, biological medicinal products constitute the Agency’s EU areas of focus. The regulation of biological medicinal products is based on many other branches of science than pharmacology and pharmaceutics, such as biochemistry, cell and molecular biology, microbiology, virology and immunology. The very latest scientific knowledge is applied to the regulation on a case-by-case basis, since the guidelines are not very detailed.
The National Agency for Medicines makes a continuous effort to enhance its expertise in the control of biological medicinal products and to improve networking with outside experts. The Agency’s experts have taken part in the classification of several bio(techno)logical medicinal products, provided scientific advice, assessed marketing authorisation applications in the centralised and mutual recognition procedures as well as in referrel proceduresas. The Agency’s experts have frequently held key positions in the preparation of EU guidelines for biological and biotechnological medicinal products.