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State food and drug supervision bureau promulgated the drug registration management measures
Policies and regulations -
State food and drug supervision bureau promulgated measures for the management of drug registration < p> 2017 -
16 13:25:17 < / p> state food and drug supervision bureau promulgated the measures for the administration of drug registration on February 28, 2005, the state food and drug supervision bureau of the 17th bureau order signed zheng xiaoyu, formally promulgated the newly revised 'drug registration management approach' (
Hereinafter referred to as the 'method')
The 'method' in on May 1, 2005 formally implemented, 'drug registration management measure (
Be abolished at the same time.
This is the state food and drug supervision bureau according to the administrative permit law control to modify the first administrative rules.
The 'method' also made clear the research development of new drugs, the state encourages the development of new drugs, new drugs in the treatment of complicated critical diseases and emergency drugs needed for a quick approval.
Due to the drug registration management measures (
'Before the' administrative licensing law 'promulgated, some content is not completely accord with the requirement of the administrative permit law, if the application of the time limit for acceptance, examination and approval, approval documents of delivery and so on.
At the same time, the drug registration management measures (
'Since the implementation of drug registration management also appeared a series of new situations and new problems, the state food and drug administration has issued some regulatory documents, and made further clear about the problem, such as the supplementary provisions for drug registration management and the supplementary provisions of the non-prescription drugs registration approval, etc.
In order to make the relevant content into a unified regulation, the changes will increase the relevant provisions in the 'method', and the specification of the individual words.
Revised the methods adapted to the 'administrative permit law' and the 'drug administration law and its' implementation regulations 'regulation, and regulate the drug registration accordingly accept way, establishes a new model for examination and approval of the drug registration: ShengJu form first review, will be accepted after confirmation in line with the integrity, after accepting ShengJu conduct on-site verification, review its authenticity and normative, at the same time start the drug registration, inspection, ShengJu review after the completion of the review conclusion and declare all information submitted to the state food and drug administration, the state food and drug administration organization for technical review, finally made a decision of whether to approve.
This has also made the adjustment, the methods of chapters chapter, a total of 16, two hundred and eleven.
This revision mainly based on four principles: adhere to the principle of 'administrative licensing law';
Adhere to the 'drug administration law and its regulations on the implementation of the principle of;
To the execution of the current means to perfect further the question of principle;
Because the implementation of the current way is smooth, the administrative relative person also hope to be able to maintain a relatively stable, as a result, this revision also adhere to the 'can not change will not change' principle.
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