The new method of veterinary medicine, where does the sword mean?

- The new "Regulations on the Administration of The Approval Number of Veterinary Pharmaceutical Products (Revised Draft)"
7X5Recently, the General Office of the Ministry of Agriculture issued a letter of consultation on the Measures for the Administration of the Approval Number of Veterinary Pharmaceutical Products (revised draft) (hereinafter referred to as the "Revised Draft"). The previous version of the Measures for the Administration of the Approval Number of Veterinary Pharmaceutical Products (hereinafter referred to as the current regulations) came into effect on January 1, 2005, nine years ago.
7X5 .Each revision of the regulations, will inevitably reveal the government regulatory authorities of new ideas, new directions, but also inevitably involve the development of thousands of veterinary drug enterprises and even life and death. And this "revised draft", although still in the consultation stage, has not yet settled the dust, but it can also be a glimpse of the veterinary drug industry regulatory New Deal.
7X5 .So, where does the new law mean?
7X5 .Approval and centralization Supervision from the
7X5"revised draft" compared with the current regulations, the provisions of the article s. more than four, changes mainly concentrated in the second chapter, that is, the approval of the number application and the issuance part. The first change is that all veterinary drug product approval numbers are approved and issued by the Ministry of Agriculture.
7X5 .The "Revised Draft" stipulates that the following three types of veterinary drug products will no longer pass the "provincial people's government veterinary administrative department" inspection and review, but will be unified to the Ministry of Agriculture and by the China Veterinary Drug Inspection Institute for inspection and examination:
7X5 , the existing national standards for veterinary drugs of biological products veterinary drug products;
7X5 .2. The product produced by the applicant for the registration of the new veterinary drug, which has been obtained by the enterprise and whose registration review sample has been obtained;
7X5 .3. Applyforing for transfer by another person has obtained the "New Veterinary Drug Registration Certificate" or "Importveterinary Veterinary Drug Registration Certificate" of veterinary biological products of veterinary medicine products.
7X5 .While transferred by others, non-biological products and other non-biological products and other non-biological products products that have obtained the "New Veterinary Drug Registration Certificate" and other non-biological products products that already have national standards for veterinary drugs are still subject to the inspection and examination by the "provincial people's government veterinary administrative department" before declaring the Inspection and Review of the Ministry of Agriculture. "Applying for joint development of the enterprise has obtained the "new veterinary drug registration certificate" of veterinary drug product approval number, but the registration of the sample review is not the applicant's production" situation has also been adjusted accordingly.
7X5 .　　In addition, the comparison shows that the "revised draft" has more requirements for the application materials. If you apply for the approval number of the biological products products of the national standard for veterinary drugs, the original contract for the transfer of veterinary drugs intellectual property rights shall be provided with information such as the production process of the product, the original certificate of the legal source of the bacteria (poison, insect) and the products with intellectual property rights. This is undoubtedly a heavy blow to the current situation of counterfeiting in the veterinary drug industry.
7X5 .　　Comparison of tests and online sampling, on-site verification is also a highlight of the "revised draft", such as Article 10: "If the trial review is not passed at the prescribed time, stop production and cancel the approval number of veterinary drug products." Article 11 stipulates: "Where an application is included in the approval number of veterinary drug products in the Ministry of Agriculture's catalogue of experimental veterinary drugs, in addition to submitting information in accordance with Article 9, carrying out on-site verification and sampling three batches (of which online sampling of one batch, on-site sampling of two batches), and reviewing the inspection, the applicant shall also submit relevant pharmaceutical research materials, matching test plans and comparison test agreements and other information
..." 7X5 can be seen that the "revised draft" focuses on the current homogenization of the domestic veterinary drug market "imitation" of the wind, and hope that with the use of rigorous audit and long approval process, stifling a number of vicious competition of small enterprises. For example, the time of biological products in china veterinary drug inspection institute was increased from 120 working days to 180 working days, and for non-biological products, the review and inspection time in the provincial departments was 90 working days, and the time reported to the Ministry of Agriculture was 60 working days;
7X5 .　　The declaration of "cost" high, for enterprises undoubtedly have advantages and disadvantages, on the whole, or conducive to the industry shuffle integration of the momentum.
7X5 .　　It is worth noting that the "revised draft" adds three types of revocation of the approval number: change the group to add other veterinary ingredients; There is renewed signs of increased regulatory strength.
7X5 .　　Progress shows doubts still
still doubts remain
7X5 of course, the new content of the "revised draft" more reflects the humanization of supervision, such as the original regulations stipulated that the preparation format of the code is: veterinary drug category short name and year number , enterprise location province (autonomous region, municipality directly under the central government) serial number and enterprise serial number and veterinary drug species number, "revised draft" is changed to veterinary drug category short , enterprise name ( autonomous region , municipality) serial number and enterprise number , At the same time, it is clear that the approval number of temporary veterinary drug products issued by the Ministry of Agriculture is referred to as "beast drug Pro-word", replacing the previous form of documents, in a more standardized way to reflect.
7X5 .　　Article 15 stipulates that if an enterprise has conducted a comparison of the experimental products or off-site production and the results are in accordance with the provisions, the application for the approval number of veterinary drug products shall no longer be compared with the test, and shall be carried out in accordance with Article 8 of these Measures. Article 16 stipulates that after the expiration of the validity period of the approval number, the comparison test has been carried out and the results are in accordance with the provisions, and no comparison test shall be conducted when the approval number is renewed.
7X5 .　　Article 16 stipulates that the replacement of the approval number of veterinary drug products does not require a review and inspection in principle. Except in the following cases:
7X5 (i) veterinary biological products with approved numbers have not been produced within the validity period;
7X5 .　　(2) If the animal biological products with the approved number fail to supervise and inspect them during the validity period;
7X5 .　　(3) Veterinary pharmaceutical products other than animal biological products are not supervised and sampled during the validity period;
7X5 .　　(4) The veterinary drug products other than the biological products used in animal scantitoes fail to be tested within the validity period;
7X5 .　　(5) Other review and inspection that is approved by the Ministry of Agriculture.
7X5 .　　Article 18 If it is clear that the veterinary drug products urgently needed for the prevention and control of major animal diseases in China may be issued with the approval number of temporary veterinary drug products, and the approval number of temporary veterinary drug products shall not be valid for more than 2 years.
7X5 .　　Wait, it's all right.
7X5 .　　Of course, the "revised draft" supporting policies and documents have not yet come out, as mentioned above compared to the test, on-site verification of how to carry out, will consume the enterprise how much time and cost, or the mystery. It may have a negative impact on the formal enterprises that work against the chapter, and encourage the "underground pharmaceutical factory" to be the wrong wind. Where a veterinary drug production enterprise builds a new workshop and changes the production site to produce veterinary medicine, it shall apply separately for the approval number of veterinary drug products. "The regulations remain, causing some "trouble" for companies to expand their production capacity. Therefore, the new law is the "double-edged sword", veterinary drug industry norms of the road is still long-distance long-distance.
7X5
- The new "Management Measures for the Approval Number of Veterinary Pharmaceutical Products (Revised Draft)" analysis
7X5 recently, the General Office of the Ministry of Agriculture issued a letter of opinion on the "Regulations on the Administration of Veterinary Drug Product approval numbers (revised draft)" (hereinafter referred to as "revised drafts"). The previous version of the Measures for the Administration of the Approval Number of Veterinary Pharmaceutical Products (hereinafter referred to as the current regulations) came into effect on January 1, 2005, nine years ago.
7X5 .　　Each revision of the regulations, will inevitably reveal the government regulatory authorities of new ideas, new directions, but also inevitably involve the development of thousands of veterinary drug enterprises and even life and death. And this "revised draft", although still in the consultation stage, has not yet settled the dust, but it can also be a glimpse of the veterinary drug industry regulatory New Deal.
7X5 .　　So, where does the new law mean?
7X5 .　　Approval and centralization Supervision from the
7X5 "revised draft" compared with the current regulations, the provisions of the article s. more than four, changes mainly concentrated in the second chapter, that is, the approval of the number application and the issuance part. The first change is that all veterinary drug product approval numbers are approved and issued by the Ministry of Agriculture.
7X5 .　　The "Revised Draft" stipulates that the following three types of veterinary drug products will no longer pass the "provincial people's government veterinary administrative department" inspection and review, but will be unified to the Ministry of Agriculture and by the China Veterinary Drug Inspection Institute for inspection and examination:
7X5 , the existing national standards for veterinary drugs of biological products veterinary drug products;
7X5 .　　2. The product produced by the applicant for the registration of the new veterinary drug, which has been obtained by the enterprise and whose registration review sample has been obtained;
7X5 .　　3. Applyforing for transfer by another person has obtained the "New Veterinary Drug Registration Certificate" or "Importveterinary Veterinary Drug Registration Certificate" of veterinary biological products of veterinary medicine products.
7X5 .　　While transferred by others, non-biological products and other non-biological products and other non-biological products products that have obtained the "New Veterinary Drug Registration Certificate" and other non-biological products products that already have national standards for veterinary drugs are still subject to the inspection and examination by the "provincial people's government veterinary administrative department" before declaring the Inspection and Review of the Ministry of Agriculture. "Applying for joint development of the enterprise has obtained the "new veterinary drug registration certificate" of veterinary drug product approval number, but the registration of the sample review is not the applicant's production" situation has also been adjusted accordingly.
7X5 .　　In addition, the comparison shows that the "revised draft" has more requirements for the application materials. If you apply for the approval number of the biological products products of the national standard for veterinary drugs, the original contract for the transfer of veterinary drugs intellectual property rights shall be provided with information such as the production process of the product, the original certificate of the legal source of the bacteria (poison, insect) and the products with intellectual property rights. This is undoubtedly a heavy blow to the current situation of counterfeiting in the veterinary drug industry.
7X5 .　　Comparison of tests and online sampling, on-site verification is also a highlight of the "revised draft", such as Article 10: "If the trial review is not passed at the prescribed time, stop production and cancel the approval number of veterinary drug products." Article 11 stipulates: "Where an application is included in the approval number of veterinary drug products in the Ministry of Agriculture's catalogue of experimental veterinary drugs, in addition to submitting information in accordance with Article 9, carrying out on-site verification and sampling three batches (of which online sampling of one batch, on-site sampling of two batches), and reviewing the inspection, the applicant shall also submit relevant pharmaceutical research materials, matching test plans and comparison test agreements and other information
..." 7X5 can be seen that the "revised draft" focuses on the current homogenization of the domestic veterinary drug market "imitation" of the wind, and hope that with the use of rigorous audit and long approval process, stifling a number of vicious competition of small enterprises. For example, the time of biological products in china veterinary drug inspection institute was increased from 120 working days to 180 working days, and for non-biological products, the review and inspection time in the provincial departments was 90 working days, and the time reported to the Ministry of Agriculture was 60 working days;
7X5 .　　The declaration of "cost" high, for enterprises undoubtedly have advantages and disadvantages, on the whole, or conducive to the industry shuffle integration of the momentum.
7X5 .　　It is worth noting that the "revised draft" adds three types of revocation of the approval number: change the group to add other veterinary ingredients; There is renewed signs of increased regulatory strength.
7X5 .　　Progress shows doubts still
still doubts remain
7X5 of course, the new content of the "revised draft" more reflects the humanization of supervision, such as the original regulations stipulated that the preparation format of the code is: veterinary drug category short name and year number , enterprise location province (autonomous region, municipality directly under the central government) serial number and enterprise serial number and veterinary drug species number, "revised draft" is changed to veterinary drug category short , enterprise name ( autonomous region , municipality) serial number and enterprise number , At the same time, it is clear that the approval number of temporary veterinary drug products issued by the Ministry of Agriculture is referred to as "beast drug Pro-word", replacing the previous form of documents, in a more standardized way to reflect.
7X5 .　　Article 15 stipulates that if an enterprise has conducted a comparison of the experimental products or off-site production and the results are in accordance with the provisions, the application for the approval number of veterinary drug products shall no longer be compared with the test, and shall be carried out in accordance with Article 8 of these Measures. Article 16 stipulates that after the expiration of the validity period of the approval number, the comparison test has been carried out and the results are in accordance with the provisions, and no comparison test shall be conducted when the approval number is renewed.
7X5 .　　Article 16 stipulates that the replacement of the approval number of veterinary drug products does not require a review and inspection in principle. Except in the following cases:
7X5 (i) veterinary biological products with approved numbers have not been produced within the validity period;
7X5 .　　(2) If the animal biological products with the approved number fail to supervise and inspect them during the validity period;
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