On September 27, the State Food and Drug Administration issued the "Opinions on Further Improving the Food and Drug Traceability System" (hereinafter referred to as "Opinions"), and officially put forward guidance on promoting food and drug production and management to improve the food and drug traceability system.
The "Opinions" emphasize that food and drug producers and operators should assume the main responsibility for the construction of food and drug traceability systems; the source of products for their production and operation should be investigated and traceable. The main focuses of the traceability system are: raw and auxiliary materials purchase, production process, product inspection and sales destination.
In addition, the Opinions also clarify that the traceability system established by pharmaceutical and medical device manufacturers and operating enterprises is traceable to pharmaceuticals that meet the requirements of GMP and GSP. Manufacturers who do not have informational conditions can use paper records. The implementation is traceable. It is not mandatory for companies to use the established traceability system.
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Drug electronic regulatory code dispute
CFDA established a drug traceability system, which was originally derived from the drug electronic regulatory code storm at the beginning of this year.
On January 25, due to dissatisfaction with the State Food and Drug Administration (CFDA) forcing the implementation of the drug electronic supervision code, Hunan Yangtian and Da Pharmacy Enterprise Group Co., Ltd. (hereinafter referred to as “Yangtianheâ€) submitted to the Beijing No. 1 Intermediate People's Court. The indictment, the lawsuit of the State Food and Drug Administration to enforce the drug electronic supervision code is an administrative violation, should be stopped immediately.
According to the administrative complaint, Yangtianhe believes that the current electronic regulatory code for drugs is completely redundant construction, which will greatly increase social costs and increase the burden on patients. On the other hand, the drug electronic regulatory code is operated by a commercial platform such as Ali Health. Many companies are worried that Ali Health will have unfair competition in the data of pharmaceutical companies in the same industry.
On February 22, the State Food and Drug Administration announced that it would suspend the use of the electronic drug regulatory code system. However, during the suspension of the drug monitoring code system, the actual platform is still operating normally, and the pharmaceutical company can apply for the bar code normally.
At the same time, Ali Health announced that it will discuss the transfer of the drug electronic supervision network with CFDA. Ali Health said that the ownership of the drug electronic regulatory code has always belonged to the CFDA, and Ali Health only provides technology and maintenance services as an operator.
On March 23, in response to the suspension of the drug monitoring code, the State Food and Drug Administration publicly solicited the revision of the "Quality Management Standards for Pharmaceutical Products" and canceled the requirements for mandatory electronic supervision of the circulation operation in the original specification; April 28, CFDA Issued "Opinions on Further Improving the Food and Drug Traceability System" (Draft for Comment).
The electronic drug regulatory code refers to the use of information technology, network technology and coding technology to attach an electronic supervision code to the smallest package of drugs. Give the drug a qualified ID card through this electronic supervision code. After the implementation of electronic supervision, enterprises upload information through the electronic supervision system, so that the assigned drugs can be monitored in real time no matter where they go.
On June 17, 2010, the State Drug Administration (SFDA) issued the Notice on Doing a Good Job in the Electronic Supervision of All Kinds of Essential Drugs, stipulating that the successful bidders for the production of essential drugs should be before March 31, 2011. Join the drug electronic supervision network, in accordance with the provisions of the code, nuclear injection verification and the company's own early warning preparations.
Before the launch of this system in 2010, the industry had discussed several issues of conflict on this issue, but in the end CFDA began to implement security considerations such as traceability management.
At the end of 2015, CFDA “Notice No. 284 of 2015†and “Notice No. 176 of 2015†strengthened the requirements of the new edition of “Good Manufacturing Practices for Pharmaceuticals†(hereinafter referred to as “new GSPâ€) – as of January 1, 2016, All pharmaceutical companies that have not passed the newly revised drug GSP certification will stop drug business activities. The local food and drug supervision bureau is required to review the uncertified enterprises one by one and stop the pharmaceutical business activities of the enterprise.
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