On January 21, the State Council issued the decision on the third batch of cancellation of administrative licensing matters designated by the central government (hereinafter referred to as the "decision"), which said that the State Council decided to cancel 39 administrative licensing matters designated by the central government.

Prior to this, the State Council has twice made provisions to cancel the examination and approval of administrative matters, involving a total of 230 major items, including enterprise operation, individual employment and entrepreneurship, and so on. The State Council said that the cancellation of the examination and approval of these matters is conducive to local decentralization and the convenience of enterprises.

It is understood that among the 39 items canceled this time, three are related to the pharmaceutical industry, involving pharmaceutical excipients, Internet drug trading services, and qualification of drug clinical trial institutions.

In terms of Internet drug trading services, after the approval is canceled (except for third-party platforms), the provincial food and drug administrations should strengthen the "drug production enterprise license", "drug wholesale enterprise license" and "drug retail enterprise license", and strictly check the Internet drug trading service enterprises. At the same time, establish an online information release system to facilitate public inquiries, guide the public to use drugs safely, establish an online drug sales testing mechanism, strengthen supervision and inspection, and investigate and deal with illegal acts in accordance with the law.

   1. Pharmaceutical e-commerce or welcome benefits

After the news of the cancellation of the approval of Internet drug trading services came out, industry insiders said that pharmaceutical e-commerce may welcome benefits, and the lowering of the threshold will bring new market forces to the industry, but at the same time it will also bring higher requirements to the soundness and standardization of the industry.

A person from the marketing department of a pharmaceutical e-commerce company said that pharmaceutical e-commerce is definitely a major trend in pharmaceutical circulation in the future. According to the type of platform, A- card enterprises are mainly used as a platform for information aggregation and release, and the amount required is limited, so it is of little significance to open up the approval. From the perspective of B2B, which is self-built or jointly organized by the pharmaceutical industry and pharmaceutical circulation, opening up the approval means that e-commerce channels can be used, this allows everyone to actively explore when the current platform companies have not yet formed a system standard; for C- card companies, the foundation is retail chain companies, and there are nearly a thousand large retail chain companies in the country. If Open the approval, these companies will have the momentum to develop e-commerce.

According to the data inquired by the State Food and Drug Administration, as of January 22, 2017, there were 831 "Internet Drug Trading Service Qualification Certificates", including 41 certificates A (third-party platforms), 195 certificates B (B2B websites built by pharmaceutical industry and circulation enterprises) and 598 certificates C (B2C websites applied by retail chains).

    2. Regulation is the focus

Industry insiders said that this is not the first adjustment of pharmaceutical e-commerce related policies. Since the promulgation of the Interim Provisions on the examination and approval of Internet drug trading services (hereinafter referred to as the "Regulations") in 2005, in addition to the three types of qualifications A, B and C, a third-party retail pilot was carried out in 2013, with 95095, 800 and No.1 stores obtaining the pilot qualification. However, in August last year, the relevant departments stopped the pilot of these three platforms. The platform has also begun to move towards a "proprietary platform" model. The original trading function can still be used, but the trading method is changed to telephone confirmation and offline payment.

He pointed out that this also shows that the demand space of pharmaceutical e-commerce actually exists, and the policy cannot be treated with a simple "shut down" attitude. The liberalization of the approval of B and C certificates also reflects the attention of the regulatory authorities.

The "Regulations" mentioned that the provincial food and drug administrations should improve the supervision mechanism during and after the event, and the establishment of an information release system and an online drug sales testing mechanism have also brought new thinking to the pharmaceutical e-commerce industry. Such as product traceability system, as well as consumer trust issues.

It is worth noting that at the same time as the regulations to cancel the examination and approval were released, the Food and Drug Administration also released relevant information on "National Drug Code Code Data", saying that the code, supervision code and classification code together form the national drug code system and have traceability function. The first batch of published code codes include 163800 domestic drugs and 3754 imported drugs.

The aforementioned sources said that the drug coding system is closely related to pharmaceutical e-commerce. Consumers can query drug information through electronic supervision codes to determine the authenticity of drugs, which is very helpful to build trust in pharmaceutical e-commerce. Previously, the drug coding system has undergone a change from government-led (electronic regulatory code system) to enterprise autonomy, with the aim of clarifying the responsibility system. After the establishment of the product traceability system, the trust problem of pharmaceutical e-commerce can be solved, and the online sale of prescription drugs may also be opened.

However, the cancellation of the approval is not all good news. He also said that after the cancellation of the approval, there are still problems of post-mortem supervision, including the continuation of qualifications, cross-provincial sales, and inconsistent policies in various regions. Further detailed policies need to be observed.