| Popis: |
The risks of biotechnology-derived products and other biologicals are different from the risks of small chemical entities and, thus, their risk management will have special features. For many biological products, the safety is mainly dependent on the starting materials and the manufacturing process. Therefore, their risk management must be focused accordingly. In certain issues, such as immunogenicity of recombinant DNA products, a proper risk management plan can only be built during the pre-licensing studies. Application of special epidemiological methods for investigation of very rare safety signals is crucial for some biologicals, e.g. vaccines. Genetically modified viruses used as vaccines and vectors for gene transfer, as well as xenogeneic cells, carry major public health risks. Therefore, the use of such products is possible only with extensive risk management programmes. Some elements of these programmes may be difficult to enforce because of legal, ethical and practical obstacles. The main special risk of biologicals is the transmission of infectious agents. The mitigation of this risk is complicated by the ever-changing epidemiological situation and the long latency of some infections. The impact of any measure for risk reduction of essential products, such as vaccines and plasma-derived medicinal products, must be considered carefully from the overall benefit/risk point of view. The risk must be reduced to the lowest level that is reasonably achievable without unduly putting the availability of essential products at risk. Adequate expertise and consultations with special experts are important in the risk management of the new advanced therapies in order to ensure the full understanding of the risks and to avoid creating unnecessary barriers for innovation. Due to the sensitive issues linked with biotechnology-derived products and other biologicals, risk communication is of critical importance. From the regulatory point of view, the risk management of biologicals is far from optimal, especially in the EU where legislation lags behind the progress in the field, and where the concerted actions of the national regulatory agencies need improvement. From the industry point of view, the risk management plans for biologicals should be designed in multidisciplinary teams. |
