Implementation of major policies affects all pharmaceutical enterprises
Last Update: 2020-01-03
Search more information of high quality chemicals, good prices and reliable suppliers, visit
For all pharmaceutical companies, the layout of drug traceability is a must to do thing, only in advance to seize the opportunity, in order to be invincible in the competition On December 1, the new version of the drug administration law was officially implemented, and the new drug administrative penalty discretion standard was issued, and drug companies ushered in the strongest supervision in history This means that drug traceability has also begun to be implemented For the construction of drug traceability system, relevant laws have made provisions for drug supervision and administration departments, drug related enterprises and institutions: The drug supervision and administration department shall formulate unified drug traceability standards and specifications, recommend the exchange and sharing of drug traceability information, and realize drug traceability When engaging in drug development, production, marketing and use activities, laws, regulations, rules, standards and specifications shall be followed to ensure the authenticity, accuracy, integrity and traceability of the whole process information Drug listing license holders, drug manufacturers, drug distributors and medical institutions shall establish and implement a drug traceability system, provide traceability information in accordance with the provisions, and ensure drug traceability On the same day, the vaccine management law of the people's Republic of China was formally implemented, and strict main responsibility was set for the whole process of vaccine Every vaccination should realize the traceability of the whole process of information To some extent, the requirements for pharmaceutical enterprises to establish an information-based traceability system have already been put in place, and the promotion and establishment of the traceability system should start from the vaccine enterprises Recently, the Central People's Government of the people's Republic of China issued the document notice on the construction of vaccine information traceability system (hereinafter referred to as the notice) It is clear in the notice that a vaccine information traceability system shall be established, and the holders of the listing license shall bear the main responsibility for the construction of the vaccine information traceability system, and the vaccine information traceability system shall be established in accordance with the principle of "one thing, one code, and the same code" The holder of the listing license can establish a vaccine information traceability system by himself or through a third-party technical institution At the same time, there is not much room for ordinary pharmaceutical companies to buffer On March 8, 2019, Beijing Municipal Food and Drug Administration issued the notice on strengthening the drug supervision during the pilot period of centralized drug purchase and use, which issued a "dead order" to establish a drug traceability system for pharmaceutical enterprises: Beijing selected drug manufacturers should complete the construction of information traceability system by the end of 2019, and foreign selected drug manufacturers should complete the information by the end of 2020 Construction of traceability system Up to now, there have been drug supervision systems in Shandong, Gansu, Hainan, Heilongjiang, Guangxi, Hubei and other provinces, which have issued the notice on the construction of drug traceability system Nowadays, there are more and more expressions of "retroactivity" in the national policy, which has vaguely revealed some signals In the 15 years from stagnation to restart, the expression of drug traceability code has changed, and the establishment subject has been transferred from the government to the enterprise itself; the enterprise can build its own system or cooperate with a third party However, the industry is generally optimistic about the mode of cooperation between pharmaceutical enterprises and third-party platforms On the one hand, the investment cost of self built systems of pharmaceutical enterprises is very large, from the installation of the inkjet printer to the maintenance of the software system is not cheap On the other hand, compared with many third-party platforms, the self built traceability system of enterprises has a large gap in talent, technology, hardware and equipment, and it is difficult to retain the real excellence Outstanding technical talents At present, the third-party platform presents a competitive pattern of Wanma Pentium, among which alihealth has become a leading enterprise because of its strong data processing ability, obvious cost tracing advantage and perfect resources of the whole industry chain It is understood that through three years of market-oriented operation, more than 90% of Chinese pharmaceutical manufacturers and 100% of vaccine manufacturers have settled on the "code" "Heart" traceability platform In addition to drug traceability, the traceability platform of "ease on the code" has also continued to expand its application, covering a variety of non drug fields such as imported food, mother and infant milk powder, tonic and health products, cosmetics, agricultural products, fresh general merchandise, etc., using one thing one code traceability technology to track commodities, collecting production, transportation, customs clearance, inspection application, third-party inspection and other information, Build a bridge between enterprises and consumers through traceability platform To this end, Alibaba Health said to Cyprian blue, "rest assured on the code" supports the seamless migration of historical data of two networks of enterprises Relying on Alibaba cloud's powerful computing and data processing capabilities, it can process hundreds of billions of large code data and support 100000 enterprise users, with good compatibility, openness and security For enterprises, the cost of purchasing and installing hardware equipment such as inkjet printer, scanning equipment, software development and later maintenance will increase, while Ali health will minimize the ecological cost of the third-party operation mode, and follow the retroactive state of the original China drug electronic regulatory network Production enterprises and wholesale enterprises do not need secondary equipment investment Because the technical level is still under exploration, and the requirements of the code system and system are "consistent" and "unified" Currently, Alibaba health's retroactive code has been frequently used in the industry, terminals, and related government agencies, and has a high authority in the industry in China When it comes to the third-party platform cooperation mode, the eternal proposition is data protection - the information contained in the drug traceability code, to a certain extent, is the confidentiality of the enterprise If it is inadvertently disclosed, the information security of the enterprise and even the entire pharmaceutical industry will be threatened To this end, Alibaba Health said to Cyprian blue: data security is one of the most concerned issues of pharmaceutical enterprises Alibaba health mainly protects the security of enterprise traceability data from the following aspects On the one hand, Ali health has carried out three-level security certification of the Ministry of public security in strict accordance with the guidelines for the construction of drug information traceability system and the basic technical requirements for drug traceability system, so as to meet the basic data security requirements of the State Administration for the third-party platform Codex rest assured platform uses Alibaba cloud for data storage, and uses Alibaba cloud's data security protection mechanism and data use mechanism to effectively ensure the security of enterprise traceability data On the other hand, the agreement signed between Codex trust platform and the enterprise clearly defines the ownership of data, clearly defines the scope of data use and the terms of security and confidentiality of data use, and legally guarantees the legitimacy of data security of the enterprise For drug traceability code, different stakeholders expect different: pharmaceutical companies want to do quality tracking, prevent fake goods, sales analysis; dealers want to prevent fleeing goods, sales follow-up; patients want to reduce the risk of fake drugs It is understood that Ali health can provide enterprises with flow query tools, data landing services, solve problems of fleeing, performance appraisal, channel analysis report, etc., at the same time, it can also open up C terminal, provide education and management for patients and doctors There are 700 million + active users behind Ali group, and also open Alipay, mobile phone Taobao query channel According to the data, Alibaba health, as the third party tracing platform in China, has been promoting commercial and terminal code scanning through commercial operation since 2016: for example, opening the express interface service to wholesale enterprises and retail pharmacies, enterprises can connect the tracing system with the enterprise business system, and finally realize the automatic upload of trace code documents and the automatic input and automatic entry of enterprise business system The verification work improves the traceability efficiency and business efficiency of enterprises, so as to solve the traceability workload, commercial pain points and demands of wholesale enterprises For retail pharmacies, the tracking platform of "ease on the code" is actively building a standard database integrating commodity code and tracking code The scanning tracking code of retail pharmacies can directly carry out settlement work, which means that the two actions of enterprise business system calculation and drug tracking collection become one collection, and the workload of retail pharmacies is greatly reduced Because of the urgency of perfect cooperation mode and policy, many pharmaceutical enterprises that have not established traceability system or have not joined the third-party platform have shown strong interest and started the establishment of drug traceability system Ali Health told cypress blue that they have held business exchange meetings in seven provinces and regions across the country Some experts said that China's data system has been in the forefront of the international market The mobile payment represented by Alipay has made us enter the cashless era The logic of "one person, one yard, one thing and one yard" is consistent, and we have inherent genes in drug traceability.
This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only.
This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of
the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed
description of the concern or complaint, to firstname.lastname@example.org
. A staff member will contact you within 5 working days. Once verified, infringing content
will be removed immediately.