A major overhaul is ushered in 14 years!

(1) Chapter 1 General Provisions

Clarified the definition of drug business supervision, put forward principled requirements for the drug marketing authorization holder system and drug traceability system; increased the quality requirements of drug use links, and the General Administration of Market Supervision unified the management and use of law enforcement functions
.

(2) Chapter II Business License

The approval for the establishment of pharmaceutical business enterprises and the GSP certification of pharmaceuticals have been cancelled, and the licensing conditions, initial acceptance standards, and approval procedures for pharmaceutical business have been stipulated
.
Require all provincial-level drug supervision and management departments to formulate inspection and acceptance rules in accordance with the "Pharmaceutical Business Quality Management Regulations" and its on-site inspection guidelines, and strictly organize on-site inspections to ensure that the "Pharmaceutical Business Quality Management Regulations" are in place; implement the "delegation of control and service", It is clear that pharmaceutical retail companies that only retail Category B OTC implement the notification commitment system for approval; the implementation of "two certificates in one" organically integrates the original drug business license application materials and drug GSP certification application materials to ensure that the standards are not lowered, and the drug supervision and management department shall follow The relevant provisions of the drug business quality management norms and its on-site inspection guidelines, inspection rules and other relevant regulations organize the technical review and on-site inspection of the application materials
.
After material review and on-site inspection, if the conditions are met, approval will be given; if the conditions are not met, a written decision of disapproval shall be made and the reasons shall be explained
.

(3) Chapter 3 Operation and Management

It mainly stipulates the contents of the drug business license, the coding rules, the verification of business scope, and the management of the change of the license.
It is clearly stated that electronic materials such as enterprise qualifications can be used; "Chapter III Business Management" reduces the number of drug networks The terms of sales are currently in principle.
For specific requirements, please refer to the "Measures for the Supervision and Administration of Drug Online Sales"; for example, the first qualification is electronic, and it is clear that the electronic version of the "Drug Business License" has the same legal effect as the printed version
.
When the holders of drug marketing permits and drug wholesale companies sell drugs, the electronic version of the first-business qualification information confirmed through network verification, electronic signature and other methods has the same effect
.

(4) Chapter 4 Quality Management of Drug Use

Mainly put forward regulatory requirements for drug business behaviors, clarify the responsibilities and obligations of drug marketing license holders, drug manufacturers, and drug business companies; clarify requirements for the management of retail chains; make online sales conditions and sales platform obligations Regulations: It is clear that the holder’s entrusted sales of drugs, online sales of drugs, and entrusted drug storage and transportation shall be managed in accordance with the record
.

(5) Chapter 5 Supervision and Inspection

Refine the responsibilities of provincial, city and county drug regulatory agencies, clarify the form and means of supervision, require drug regulatory agencies to formulate annual supervision and inspection plans, strengthen risk management concepts, clarify the focus and frequency of inspections, and implement and strengthen matters The requirements for subsequent supervision and inspection frequency are as follows:

(6) Chapter VI Legal Liability

Mainly penalties for penalties for violations of business license regulations and business activity requirements in the drug business process
.
For illegal acts that are not clearly required or need to be clearly defined in the "Drug Administration Law", link the corresponding penal provisions of the "Drug Administration Law" and propose penalty clauses.
It is clear that the purchase or storage of counterfeit and inferior drugs for the purpose of sale and use is directly Recognized as the act of selling and using counterfeit and inferior drugs
.

(7) Chapter Seven Supplementary Provisions

The main purpose is to clarify the contents that are not included in the main text, such as special management drugs and user unit management
.
It stipulates the interpretation power and implementation time of the "Measures"
.

references

[1]and NMPAIE circulation supervision

Columnist: Dripping Sinan

Senior biomedical engineer, licensed pharmacist, and porter of pharmaceutical policies and regulations in the self-media era, he insists on the goal of lifelong learning, adheres to the combination of learning and application, and strives to achieve the unity of knowledge and practice
.