The new era of pharmaceutical logistics, the new policy of pharmaceutical modern logistics will be implemented on April 6

In order to deepen the reforms of the State Council and the Shanghai Municipal Government to "delegate control and service" , further promote the healthy and orderly development of Shanghai's pharmaceutical modern logistics industry, promote the large-scale and standardized development of pharmaceutical distribution enterprises, and ensure the quality and safety of pharmaceuticals in the logistics link , April 2021 On the 6th, the Shanghai Drug Administration’s official website issued a major release of the "Notice on Printing and Distributing the "Guiding Opinions on Modern Logistics of Shanghai Pharmaceuticals (Trial)" (Shanghai Yaojian Regulation [2021] No.
1), since the date of issuance (2021) It will come into effect on April 6th, and it will be valid for 2 years
.

In the current epidemic situation, the Shanghai Drug Administration has been optimizing based on the principle of "standards are not lowered, and processes can be optimized", and pioneered the exploration of new drug logistics supervision methods, which embodies the supervision concept of "decentralization, regulation and service" reform
.

1

Inventory of modern pharmaceutical logistics policies under new business conditions

In recent years, the country has deeply promoted the implementation of policies such as the medical reform and the "4+7, two-invoice system", and the merger and reorganization of the pharmaceutical distribution industry has accelerated
.

01

Advancing the development of modern logistics of pharmaceuticals based on policy

● "Opinions on Strengthening Drug Supervision and Management to Promote the Development of Modern Pharmaceutical Logistics" (Guo Shi Yao Jian Shi [2005] No.
160), "Notice on the implementation of the "Opinions on Strengthening Drug Supervision and Management to Promote the Development of Modern Pharmaceutical Logistics" "(National Food and Drug Administration [2005] No.
318), "Notice on Forwarding the State Food and Drug Administration's "Notice on Implementing the "Opinions on Strengthening Drug Supervision and Management and Promoting the Development of Drug Modern Logistics"" (Shanghai Food and Drug Administration Circulation [2005] No.
479) and other regulations suggest that non-pharmaceutical wholesale companies can also engage in third-party drug logistics business after they meet certain conditions and obtain the "Confirmation for Carrying out Third-Party Drug Logistics Business" issued by the Food and Drug Administration
.

       On February 3, 2016, in order to implement the national policy requirements such as "simplification of administration, delegation of powers and decentralization of control and services", the State Council issued the "Decision on the Second Batch of Cancellation of 152 Administrative Examination and Approval Items Designated by the Central Government" (Guofa [2016] No.
9), cancel the approval items for engaging in third-party drug logistics business
.

       In 2017, "Several Opinions of the General Office of the State Council on Further Reforming and Improving Policies for the Production, Distribution and Use of Drugs" (Guobanfa [2017] No.
13) and "Drug Administration Law of the People's Republic of China" (Order No.
31 of the President of the People's Republic of China) "China The Vaccine Administration Law of the People’s Republic of China (Order No.
30 of the President of the People’s Republic of China) requires the promotion of the transformation and upgrading of pharmaceutical distribution enterprises, encourages multi-warehouse coordination and cross-regional distribution, and leverages the "Internet + drug circulation" in reducing transaction costs and improving circulation efficiency.
Role
.

       02

       Develop provincial-level pharmaceutical modern logistics guidance documents

       ● Many provincial drug regulatory bureaus have issued relevant regulations on modern pharmaceutical logistics in their provinces at different times.
The following summarizes the policies related to pharmaceutical modern logistics promulgated by some provinces and cities:

       2

       "Shanghai Pharmaceutical Modern Logistics Guiding Opinions"

       Interpretation of the main content

       01

       What are the main requirements of the organization and personnel?

       ● The "Guiding Opinions on Modern Pharmaceutical Logistics of Shanghai (Trial)" requires that enterprises engaged in pharmaceutical modern logistics business meet the relevant requirements of pharmaceutical GSP and traffic control transportation for their corporate qualifications, pharmaceutical quality management, and logistics technical management personnel.
Organization 3 Department 2 Logistics management full-time personnel 3 Key personnel put forward specific conditions
.

       02

       What are the main requirements for facilities and equipment?

       ● The "Guiding Opinions on Modern Pharmaceutical Logistics of Shanghai (for Trial Implementation)" has the following requirements for the storage area or volume and transportation vehicles for newly established pharmaceutical wholesale enterprises, pharmaceutical wholesale enterprises engaged in the business of entrusted storage and transportation of drugs, and pharmaceutical wholesale enterprises specializing in biological products.
:

       03

       What are the main requirements of the information management system?

       ● "Shanghai Modern Pharmaceutical Logistics guidance (Trial)" requires enterprise information management system should have the warehouse management, transportation management, temperature and humidity monitoring and other functions
.

       Pharmaceutical wholesale companies that carry out the business of entrusted storage and transportation of drugs should be equipped with an electronic data exchange platform to support the exchange of logistics operation data and the information of entrusted storage and distribution, and have the ability to receive, check and accept, store in, store, maintain, and leave the entrusting party’s drugs.

       04

       What are the applicable objects?

       ● The "Guiding Opinions on Modern Pharmaceutical Logistics of Shanghai (Trial)" is applicable to newly established pharmaceutical wholesale enterprises and pharmaceutical wholesale enterprises that carry out entrusted storage and transportation of pharmaceuticals.

       references:

       [1] hdcx.

       In order to further stimulate the endogenous power and development vitality of the market,

       Assist the construction of an intelligent collaborative system between the upstream and downstream of the pharmaceutical supply chain and the pharmaceutical logistics industry

       December 16-18, 2021

       A large-scale pharmaceutical industry chain exhibition in Shanghai will meet you

       ● Join hands with CPhl & P-MEC China series of exhibitions to create a closed loop of drug life cycle management

       ● Eight exhibition areas, covering the entire industry chain of pharmaceutical logistics