A major overhaul is ushered in 14 years!

On November 12, 2021, the State Food and Drug Administration again publicly solicited opinions on the "Measures for the Supervision and Administration of Drug Operation and Use Quality (Draft for Comments)" (the deadline for comments: November 26, 2021), in order to implement the "Chinese People The Drug Administration Law of the Republic, the Vaccine Administration Law of the People’s Republic of China and other laws and regulations.
This is a comprehensive overhaul after 14 years.
The new version of the "Measures for the Supervision and Administration of Drug Operation and Use (Draft for Comments)" has seven chapters and 89 articles.
Integrate the current "Administrative Measures for Pharmaceutical Business Licenses" (formerly the State Food and Drug Administration Order No.
6) and the "Measures for the Supervision and Administration of Drug Circulation" (formerly State Food and Drug Administration Order No.
26) to formulate more targeted The “Measures for the Supervision and Administration of Drug Sales and Management” which are both effective and operational
.

This article analyzes the background and main new and revised contents of the "Measures for the Supervision and Management of Drug Operation and Use Quality (Draft for Comment)"
.

PART 0 1.
Background of the introduction of the new regulations on the management and use of Chinese medicines

PART 0 1.
Background of the introduction of the new regulations on the management and use of Chinese medicines

At the beginning of 2019, the State Food and Drug Administration officially launched the revision of the "Measures for the Supervision and Administration of Drug Sales" and organized a special drafting team.
The Measures for the Supervision and Administration of Drug Circulation (formerly Order No.
26 of the State Food and Drug Administration) will be integrated
.

On September 30, 2019, the "Measures for the Supervision and Administration of Drug Sales" (Revision Draft for Solicitation of Comments) was released, which attracted everyone's attention.

PART 0 2.
Changes in the basic framework structure of the new and old drug management and use regulations

PART 0 2.
Changes in the basic framework structure of the new and old drug management and use regulations

The "Measures for the Supervision and Administration of Drug Operation and Use Quality (Draft for Comment)" is a combination of the "Measures for the Administration of Drug Operation License" (formerly Order No.
6 of the State Food and Drug Administration) and the "Measures for the Supervision and Administration of Drug Circulation" (formerly National The Food and Drug Administration Order No.
26) has been integrated, and the framework is basically the same as the 2017 revision.
Compared with the old version (the second revision in 2019 (the first draft), the second revision in 2021 (the first draft) The total number of articles in the 4th consultation draft) has been increased by 15 articles.
The title of Chapter 4 has been changed from "Management of Purchased and Storage of Drugs by Medical Institutions" to "Quality Management of Drug Use".
Will be greatly expanded and refined, compared with the following table:

Comparison table of new and old versions of drug management and use of new regulations

PART 0 3.
First look at the main highlights of the new regulations on drug management and use

PART 0 3.
First look at the main highlights of the new regulations on drug management and use

(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 guidance on business and use law enforcement functions
.

(2) Chapter II Business License

The approval of preparations for establishment of pharmaceutical business enterprises and the GSP certification of pharmaceuticals have been cancelled, and the licensing conditions, initial acceptance criteria, and approval procedures for pharmaceutical business have been stipulated
.

Require all provincial drug supervision and management departments to formulate inspection 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 and 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 standards and its on-site inspection guidelines, inspection rules and other relevant regulations organize the technical review and on-site inspection of the application materials

(3) Chapter 3 Operation and Management

It mainly stipulates the contents of the drug business license, coding rules, business scope verification and license change management, etc.
, and clearly states that electronic materials such as corporate 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 "Administrative Measures for the Supervision and Administration of Drug Online Sales"; for example, the electronic version of the first business qualification, it is clear that the electronic version of the "Drug Business License" has the same legal effect as the printed version
.

When a drug marketing permit holder or a drug wholesale company sells drugs, the electronic version of the first-business qualification information confirmed by means of network verification, electronic signature, etc.

(4) Chapter 4 Quality Management of Drug Use

Mainly put forward standard 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 The requirements for subsequent supervision and inspection frequency are as follows:

(6) Chapter VI Legal Liability

Mainly the 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 clarified again in the "Drug Administration Law", link to the corresponding penalties of the "Drug Administration Law" and propose penalty clauses.

(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

references

[1] and NMPAIE circulation supervision

[1] and NMPAIE circulation supervision