Fishery medicine national standard turned positive life "privileged enterprises" monopoly profit
Release time:
2023-01-20
Pan Wei was very worried about the application for the approval number of fishery drugs. A few days ago, he once again dialed the telephone of the China Veterinary Drug Inspection Institute of the Ministry of Agriculture (hereinafter referred to as the "China prison") to inquire about the approval of the fishery drug approval number. Last year, his enterprise applied to the relevant departments for the production approval of 36 kinds of veterinary drugs, and finally only passed more than 20 kinds. Of the more than 10 applications that have been brushed down, the vast majority are fishery drug approval applications. Pan Wei could not be convinced by the reply of the Chinese prison. "They (the Chinese prison) said that the national standard of the drug we applied for is still in the trial period, so it cannot be approved."
Pan Wei's enterprises in the local scale is not small, and as early as 2006 passed the GMP certification. According to him, "the production process and process must meet the requirements", but the approval result of the fishery drug approval was unexpected. Pan Wei is no stranger to the formulation of national standards for fishery drugs: "Some national standards were formulated as early as 2005. According to the regulations, they should be officially announced and released two years later. How can it be 'still in the trial period'?" He showed his anger in his helplessness.
In fact, like Pan Wei, there are not a few fishery and pharmaceutical enterprises that are facing the problem of difficult approval of production approval numbers.
Join a collaboration group to get approval
According to the relevant national documents, to obtain the veterinary drug approval number, the following procedures must be carried out: first obtain the veterinary drug production license, then pass the national GMP certification, and then submit the drugs and documents required for the application to the provincial veterinary drug supervision institute. After passing the drug inspection, it is sent to the Ministry of Agriculture for approval and approval, and finally the drug production approval number is issued. Apart from the cost, the long approval time is unbearable for enterprises: "from 2005 to now, enterprises have lost at least more than 1200 million yuan simply because they failed to apply for the approval number," Pan Wei told reporters. "in order to produce fishery drugs, enterprises must first pass GMP certification, and a production line will cost millions of yuan. If the production of a product is stuck just because a standard has not been issued, for enterprises, it's a big loss."
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