GMP Compliance for Veterinay Drugs

Ⅰ、Chinese veterinary drug GMP certification

In order to effectively cope with the increasingly complex animal diseases, countries around the world have raised the development of the veterinary drug industry to the level of ensuring public health and safety, maintaining a comprehensive, coordinated and sustainable society.

In order to promote the healthy development of the veterinary drug industry, ensure the sustained and steady growth of the animal husbandry, ensure the health of the people, continuously improve the quality of veterinary drug products, and integrate with the international veterinary drug production management as soon as possible. In 2001, the Ministry of Agriculture of China established the “Veterinary Drug GMP Working Committee”. Organized the revision of the "Quality Management Standard for Veterinary Drug Production (Trial)"; in March 2002, the Ministry of Agriculture of China promulgated a new version of the "Quality Management Standard for Veterinary Drug Production" (Order No. 11 of the Ministry of Agriculture).

Related to this, the new Regulations on the Administration of Veterinary Drugs has been implemented since November 1, 2004. Compared with the original regulations, there are mainly the following changes:

(1) Established a classification management system for veterinary prescription drugs and non-prescription drugs;

(2) Established a national veterinary drug reserve system;

(3) Established a new veterinary drug development management and safety monitoring system, and redefined the concept of new veterinary drugs, eliminating the concept of new veterinary drug formulations;

(4) Established quality management systems for veterinary drug production quality management standards, veterinary drug management quality management standards, veterinary drug non-clinical research quality management regulations, and veterinary drug clinical trial quality management practices;

(5) Established a drug record management system and a drug holiday management system;

(6) Established a monitoring and reporting system for veterinary drug adverse reactions;

(7) Established a management system for the issuance of veterinary biological products;

(8) Establish a veterinary drug production license and veterinary drug approval document number to implement the first-level examination and approval system, that is, it must be examined and approved by the veterinary administrative department of the State Council;

(9) The multi-level standard of veterinary drugs has been abolished, and the legal standards for veterinary drugs are only national first-class standards;

(10) Strengthen supervision measures, standardize law enforcement procedures, and increase penalties;

(11) The timeliness is clearly stipulated for all examinations and approvals, which fully reflects the administration according to law;

(12) Clear regulations have been made on the management of raw materials and human drugs;

(13) A clear request is made for the label of the veterinary drug and the contents of the manual;

(14) Further refine the monitoring system for drug residues in animal and animal products.

Ⅱ、the global veterinary drug GMP related situation

Up to now, many countries, regions, international organizations, and regional organizations have included quality management of veterinary drug production within their specifications, and made clear regulations:

- The current US Good Manufacturing Practice (cGMP) specifies in the General Regulations that “a small number of regulations include the current minimum quality control practices for the manufacture of human or veterinary drugs”.

- The World Health Organization (WHO) guidelines for the quality of pharmaceutical production in the introduction stated that "When the World Health Assembly recommended the first edition of the WHO Guidelines for the Quality of Drugs in International Trade as a World Health Assembly resolution, it was accepted and GMP is an integral part of the program. The 1975 Visa Outline has been expanded to include: veterinary drugs for food animals...

- The European Community Guidelines for the Quality Management of Pharmaceutical Production stated in its introduction that “the GMP regulations agreed to apply to the production of veterinary drugs are the same as those applicable to human medicinal products, and in the two annexes Some details of the GMP regulations were made with pharmaceuticals and veterinary immunizations." The European Community has enacted the Principles and Guidelines for the Establishment of GMP for Veterinary Drugs in the form of its Commission Regulations.

- The UK Pharmaceutical Production Quality Management Regulations stipulate in Article 15.1 that "veterinary medical products shall be produced in accordance with the principles set out in this specification. Due to their nature and use, the manufacturing regulations for certain veterinary products are slightly different from those for human use. This may be appropriate for the recommended regulations. Some veterinary products, such as animal large-dose topical therapeutics (sheep medicine bath), which are not directly equivalent in human medicine, are in other sections of this specification regarding production plants and Equipment recommendations may not apply, but adequate cleanliness, order and safety are always required to minimize formulation errors, contamination and contamination."

——The terminology of this standard in the third article of the General Administration of Pharmaceutical Products of the “Drug Administration of the Ministry of Health of Taiwan” is as follows: “Drug: In addition to the special provisions of this standard, the System Drug Dealer Management Law The five articles referred to in the Article 3 of the Animal Drug Administration Regulations for 'pharmaceuticals' are referred to as 'animal drugs'."

At present, China, Australia and other countries in the world have developed the "Quality Management Standard for Veterinary Drug Production" for veterinary drug production according to the actual situation of the country.

Ⅲ、the development trend of China's veterinary drug industry

Since 1992, China's meat and egg production has leapt and maintained the number one in the world. The continued development of the livestock industry has led to the development of related industries such as the veterinary drug industry and the feed industry.

At present, China has become the second largest consumer of veterinary drugs after the United States. From 2003 to 2011, the compound growth rate of sales revenue of China's veterinary drug industry exceeded 35%. According to the National Bureau of Statistics, in 2011, China's veterinary drug industry showed a good development trend. The veterinary drug industry realized a total industrial output value of 72.908 billion yuan; realized sales income of 69.815 billion yuan, a year-on-year increase of 35.04%; realized total profit of 7.109 billion yuan, a year-on-year increase 38.14%.

As of 2011, there are 436 veterinary drug companies in China, including medium-sized enterprises and small enterprises. Among them, there are 35 medium-sized enterprises, with sales income of 16.382 billion yuan, accounting for 23.46%; 401 small enterprises, with sales income of 53.434 billion yuan, accounting for 76.54%, small and medium-sized enterprises are still the main enterprise form in the industry.

The National 12th Five-Year Plan for Animal Husbandry Development clearly states that the comprehensive production capacity of animal husbandry during the 12th Five-Year Plan period will be significantly enhanced, and the scale, standardization and industrialization will be further improved. It is estimated that by 2015, the output of meat, eggs and milk will reach 85 million tons, 29 million tons and 50 million tons respectively, and the wool production will reach 430,000 tons. The output value of animal husbandry accounts for 36% of the total output value of agriculture, forestry, animal husbandry and fishery. The good development prospects of the animal husbandry will continue to drive the veterinary drug industry to move forward steadily.

It is expected that in the next few years, with the sustained and rapid development of China's animal husbandry, China's veterinary drug industry will continue to grow continuously. By 2015, the total output value of veterinary drugs can exceed 200 billion yuan.

From a global perspective, in recent years, international mad cow disease, foot-and-mouth disease, avian flu, and SARS have frequently jeopardized public health events, making the veterinary drug industry a business closely related to public health and human health.

In order to effectively cope with the increasingly complex animal diseases, all countries in the world have raised the development of the veterinary drug industry to the level of ensuring public health and safety, maintaining a comprehensive, coordinated and sustainable development of society, and actively using new scientific and technological means to develop new vaccines and strengthen animals. Detection and prevention of the epidemic.

At present, the global veterinary drug industry has entered a period of monopoly development, and the monopoly position of international giants such as Pfizer, Bayer and Melia has been formed. As of June 2010, 550 kinds of veterinary drugs from 125 foreign veterinary drug companies have been registered and sold in China, with annual sales of about 5 billion yuan.

Ⅳ、veterinary drug product approval number technical review common problem summary