Whether a yard, in the United States or the European Union's 'security file', perfecting drug traceability system has provided the reference for our country.
Recently, the state food and drug supervision bureau as 'the drugs management quality management standard' (
For public opinion, to adjust drug electronic monitoring system for drug tracing system, cancel to enforce electronic supervision code and code and data upload.
Suspended at the same time, according to the announcement of the relevant provisions of the drug electronic monitoring.
It was in January this year, issued by The General Office of the State Council 'about accelerating's opinions on important product traceability system, clearly put forward to promote special equipment such as 7 kinds of important product traceability system construction, the first put forward by the ministries and commissions system promote the programmatic document of the construction of the traceability system.
In this case, our country policy, require coding docking unification, it is imperative to reduce the burden of the equipment identification and business operation.
In fact, the current world of important commodities back system development is not balanced, especially drug tracing system, there exist some problems in the common, but relative success in the United States and the European Union.
The United States: a yard in the United States experience is that in 1988 they established the prescription drug marketing act, requirements of drug sources and sales to the implementation of records.
In order to prevent false record, the FDA (
The U. S. food and drug administration of superintendent)
And decided to adopt technology RFID (radio frequency identification
Was realized with borrow the RFID electronic tag of fast reading and writing, also realized to the movement of the target recognition, ensure the whole process of the production and circulation of medicines.
In 2011, the FDA to further promote the implementation of standardized digital identity, guarantee a yard, and in the form of bar code printing in pharmaceutical packaging.
So that ensure the layers of verification, greatly improve the transparency of the drug in the whole supply chain, the discovery of the drug problem, by gathering location and the holder of the drug, can perform the reverse logistics, make it more quickly and easily drug recall, etc.
The eu: to establish a safety file before the European Union in 2008 began to enforce hair medicine supervision code information verification, in order to realize the safety of the drug regulation and flow to the traceability system.
In September 2008, the European parliament and the council adopted 'dispensing validation' model, through balancing the European pharmaceutical industry association, the European Union and the European pharmacy pharmaceutical wholesale enterprises alliance, the European Union for generic drug makers in four aspects, such as interest, enforce hair before medicine supervision code information verification, in order to realize the safety of the drug regulation and flow to the traceability system.
In 2011, Europe's internal again by the eu against counterfeit drug instructions, clear requirements for the eu circulation every drug to build 'to verify its authenticity' the safety of the archives, and builds a database of passage in eu countries.
After implementation of this model, in addition to the national funding, producers and retailers only need money to implement the system, circulation enterprises is not investment.
For this reason, the model effect is very significant.
Our neighbouring Japan, although there is no drug special traceability system, but its food traceability system, has a mature on the traceability system, their drug traceability process is also very clear.
China: many aspects need to be perfect, in short, you can see, from the experience of foreign professional regulators and team, the modern information technology, the strict law and system construction is the three cornerstones of traceability system.
For us, complete and efficient and convenient drugs back to work, also won't happen overnight.
First of all, the standard is the premise, is the core of the traceability system.
Such records through gathering the product production, circulation, consumption and so on each link information, realize the source available, go back, responsibility to investigate.
But to do this, must be in perfect legislation and related management system, can only on the basis of legal drugs traceability system to consummate gradually.
Second, the information platform is a key to complete the traceability system.
The Internet of things, big data and cloud computing, mobile Internet promotion and application of information technology, for the establishment of the modern traceability system provides the technical foundation and the safeguard.
The place such as the United States, the European Union, tracing system perfected, its information platform development, early development soon, related technology can be reasonable application;
Many problems still exist in our country, the information platform construction, keep up with development needs, the role of very limited in the traceability system.
Finally, the strict responsibility is the powerful guarantee of the work.
This is to ensure that the barriers.
The regulators and the need to establish and improve the law enforcement team, dare to law enforcement, strict in law enforcement, whether it is which company, which enterprise in violation of the relevant system will have to cancel its qualifications, and shall not be engaged in the field a few years.
As a deterrent to illegal enterprises.
At present, our country related to drug coding including electronic supervision code, commodity barcodes, drug standard code, drug classification code and logistic bar code, etc. , drug information carried by these codes not only have repeat, and incompatible between coding, the recognition of equipment and the operation of the business has brought the repeatability, and traceability.
Experience from other countries, to perfect our country's drug tracing system, should be on the basis of understanding their own problems, draw lessons from his mountain, gradually improve related work.