《<中华人民共和国药品管理法>修正案(草案征求意见稿)》深度解读
中国商事法律评论 1-2018
To deepen the reform of drug evaluation and approval system, encourage innovations in drugs, and safeguard the rights and interests of the public in regard to drug consumption, China Food and Drug Administration (the “CFDA”) has published series of pharmaceutical laws and regulations recently. Among others, the most notable is the Drug Administration Law of the People’s Republic of China (draft for consultation) (the “Draft”) promulgated on October 23th, 2017 due to several major reforms in the area of drug registration and administration.
According to the Draft, China will fully adopt a drug Market Authorization Holder (the “MAH”) system, the approval regime of clinical trials will be simplified, and overseas trial data will be accepted in drug registration, though an on-site check by CFDA might still be applied.
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1. IMPLEMENTING THE DRUG MARKETING AUTHORIZATION HOLDER SYSTEM
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2. CANCELLING CERTIFICATES OF GMP AND GSP
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3. SIMPLIFICATION OF THE ADMINISTRATIVE APPROVAL OF CLINICAL TRIALS
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4. DEFINITUDE AND CONCRETIZATION OF LEGAL LIABILITIES
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5. CONCLUSION
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