In the past few years, biotechnology and tissue engineering have developed a great deal. Legislation, however, has not been able to keep pace with the rapid changes in the research and treatment using tissue-engineered products. The authors tried to explore and compare all the regulatory factors concerning cell and tissue engineering in the Hungarian and foreign law. The thorough study elucidated that the Hungarian regulation in this area is fairly deficient when compared with the regulations of other European countries, where quite extensive directives are applied. A currently accepted regulation fills this void efficiently in the European Union providing strong base for tissue engineering-related research and therapy for the future.