Major Changes in the Newly Revised Drug Administration Law
摘要
The newly revised Drug Administration Law (“New Law”) will come into effective on December 1, 2019. Compared with the current Drug Administration Law, significant changes with respect to the framework and the specific content have been made in the New Law. In response to the major issues in the current pharmaceutical industry, the New Law adopts several new systems, which are becoming more in line with international standards. For instance, the New Law establishes the drug marketing authorization holder system, the drug traceability system, the first accountability system, the innovation of evaluation and approval system, the unified quality management system for drug retail franchise operation and regulations of online drug sales etc. Furthermore, the New Law cancels the Good Supplying Practice and Good Manufacturing Practice certifications and adopts stricter legal liabilities. In addition, the New Law stipulates that entities or individuals importing a small amount of drugs without an importation certificate may be exempted from punishment. The New Law marks a profound change in the pharmaceutical industry. The new systems bring new challenges; the pharmaceutical enterprises need to pay close attention to the implementation rules of the New Law as they will be successively issued by the legislator in order to understand and implement the those rules. In addition, pharmaceutical enterprises will need to adjust their practical operations regarding process and management, based on the requirements of the relevant laws and regulations.
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