Shandong Provincial Food and Drug Administration issued a guidance case system t

Copyfrom： Release time：2019-07-12 The editor：

Shandong Provincial Food and Drug Administration issued a guidance case system to promote the standardization of law enforcement
 
Recently, the Shandong Provincial Food and Drug Administration issued the "Guidance Case Management Measures", which clarified the definition and effectiveness of the guiding cases of the drug regulatory system in the province, the scope of selection, and the mechanism for reviewing and issuing, etc. It improve the institutional foundation for playing a further guiding case to demonstrate the guiding role.
 

This approach mainly includes the following:
1
 
The effectiveness of the guiding case is clarified. The province's drug supervision and law enforcement work should be based on laws, regulations and rules; for cases of illegal facts, nature, circumstances, or similar cases, reference should be made to guiding cases. References can be used to quote the interpretation of the case in the guiding case, but not as a basis for law enforcement.
2
 
The scope of the guiding case selection was clarified. It mainly includes cases of difficult complex or new types, cases of comparative principles prescribed by law, cases of administrative reconsideration or administrative litigation, suspected criminal cases transferred to judicial organs, and cases involving foreign affairs or having greater influence in the region.
3
 
The guiding case review release mechanism was standardized. The Policy and Regulation Department of the Provincial Food and Drug Administration organized relevant departments, legal consultants, and public lawyers to conduct a rigorous review of the case, and to prepare alternative guiding cases in accordance with the regulations. After extensive consultation, it was released after being reviewed by the person in charge of the provincial food and drug administration. . The published guidance cases shall be regularly cleaned up according to the legal basis and the actual situation of law enforcement to ensure the quality and effectiveness of the case.
The guiding case refers to the case in which the legal effect of the drug, medical device, cosmetics supervision and law enforcement work has taken place in the province, and it has general guiding significance in handling similar cases in terms of facts, evidence collection and applicable law. The guiding case system is a positive exploration of the drug regulatory legal system. In 2018, the former Provincial Food and Drug Administration issued the first batch of guidance cases, selected typical cases such as information disclosure cases and medical device administrative punishment cases that did not meet the technical requirements for registered products, and the procedures for law enforcement practice were not standardized and applied. Controversial and other issues, through the analysis of case points, the case interpretation method, to provide specific practical guidance for handling similar cases, has been widely recognized and welcomed by the grassroots.