Legal Procedure of the Entry of Drug Manufacture in China and USA:A Comparative Study / 中国药房

ABSTRACT

OBJECTIVE: To put forward suggestions for perfecting the Chinese legal procedure of the entry of drug manufacture.METHODS: The defects existing in Chinese legal procedure for the entry of pharmaceutical industry were analyzed by comparing the legal procedure for establishing pharmaceutical enterprise,permission of drug manufacturing and marketing between China and USA.RESULTS & CONCLUSIONS: The Chinese legislature should draw useful legal experiences from USA to amend the legislation defects,substitute the approval procedure of drug manufacturing licence with the procedure of enterprise registration to implement the GMP certification for special drug product,and merge the validation procedure of GMP certification and the review procedure of the pharmaceutical development program and industry policies into the procedure of drug registration and approval.