|
As the problems of safety and drug tolerance of chemicals get ever more serious, the market of biomedicine grows rapidly to make up for the deficiencies of chemicals in remedial areas. Regulations in Taiwan and China and applications thereof which shall be followed through different stages when promoting genetic engineered medicine into market are discussed in this thesis. Since genetic engineered medicine is categorized as one sort of biomedicine, it should be in accordance with the rules set for biomedicine first and be further considered if regulations targeted to genetic engineered medicine exist.
Taiwan and China mainly impose the control of toxicity measurement regarding the rules of content in nonclinical test. Taiwan has further related regulations before entering into nonclinical test, while China does not. The procedural regulations of nonclinical test in Taiwan is mainly stipulated in Good Laboratory Practice, and for China in Good Laboratory Practice (the translation is the same but it is different in Chinese). In Taiwan, Major Review items in Clinical trials of pharmaceuticals is set as the corresponsive rules before biomedicine goes under human clinical test. While in China, Veterinary Drugs Control Act and its Enforcement Statute for are the corresponsive rules thereon. The regulatory framework in Taiwan during clinical test is referred to Good Clinical Practice, and that in China is Good Clinical Practice (the translation is the same but it is different in Chinese).
Finally, to ensure the safety of drug usage and increase the quality of medicine, Taiwan and China both make corresponsive regulations in accordance with the International standard of GMP (Good Manufactured Practice). After comparing with the regulations from both countries, it can be found that Taiwan mainly focuses on PIC/S: Guide to Good Manufacturing Practice for Medicinal Products while China concentrates in Good Manufacture Practice of Drugs.
|
