The Health and Welfare Ministry will write safety guidelines for medicine production at so-called animal plants where sheep or cows implanted with human genes will produce human proteins, ministry sources said Monday.
Animal plants are touted as being able to produce blood coagulation factors and antibodies in large volumes at low prices, the sources said. In the United States and Britain, medicines produced at such facilities are now undergoing clinical tests, they said.
The United States unveiled safety guidelines for drugs produced at such places in 1995 because the products must be under strict quality control, the sources said. Because there are plans to conduct clinical tests on such drugs in this country as well, the Health Ministry plans to ask the Central Pharmaceutical Affairs Council to draw up safety guidelines like those of the U.S., they said.
As with medicines used for genetic treatment, drugs produced at animal plants will be subject to preliminary screening by an investigation council, they said. Under the U.S. guidelines, animals from which genes are to be engineered are defined as those into which DNA is introduced through human manipulation, the sources said. To ensure the safety and efficacy of drugs made in this manner, plant operators are required to provide detailed explanations of their DNA production methods and their safety and pathogenic tests to ensure their quality.