浅谈兽用生物制品供应中存在的问题及建议

随着我国畜牧业的发展,畜禽生产由农户散养向专业化规模化饲养方向转化,养殖户的防疫意识不断增强,疫苗的销售自然成了经营的热门。据统计,辽阳市合法取得生物制品供应证的经营单位有44家,其余还有相当一部分兽药点、孵化场及个人以代购代销名义暗地经营预防用生物制品,这给防疫工作和疫苗管理带来了诸多不便,就其原因笔者浅谈以下看法。1存在问题1.1兽用生物制品购销混乱据有关报道,全国现有兽用生物制品生产企业(车间)近50家,生产品种约200个,另外还有不计其数的大学、研究院(所)生产兽     

兽用生物制品质量的监管与监督检验管理

我国政府十分重视兽药管理工作,为加强兽用生物制品质量管理,现行的《兽药管理条例》是于2004年4月9日颁布,农业部根据《兽药管理条例》又制定了一系列配套法规和规范.但新《兽药管理条例》有关规定中存在一些问题,如"兽药"的概念容易引起混淆和误解,对"兽药"的释义不利于动物药品的有效管理;兽药监督范围扩大,而兽药监督执法主体范围缩小,监督执法任务更加艰巨,不利与兽药监督执法工作的开展;相关配套法规不健全,急需进行修订和完善.其中涉及产品生产工艺,不利于保护企业的技术保密,不利于兽用生物制品质量标准的完善和提高.现将兽用生物制品质量的监管与监督检验管理介绍如下.     

我国兽用生物制品批签发管理的现状与对策分析

介绍我国兽用生物制品批签发管理的现状，就目前我国兽用生物制品批签发管理工作中存在的问题进行了分析，并从完善批签发管理办法、加强GMP管理、加大执法力度以及加大从业人员的培训力度等四个方面提出了提高兽用生物制品批签发管理的应对措施。     

发达国家兽用生物制品注册管理现状及对我国的启示

加入WTO后,中国现有的兽用生物制品注册管理法规也必须与国际通行的相关规定相协调。参考美国、欧盟、加拿大等发达国家和地区兽用生物制品注册管理体系中关于注册管理方面的规定,笔者对我国兽用生物制品注册相关的管理机构和法律基础进行简要的比较研究,找出我国在兽用生物制品注册管理上与发达国家的差异,并提出相应的建议,为我国相关法律法规和规范的修订提供参考。     

浅析兽用生物品经营环节存在的问题及对策

兽用生物制品特别是疫苗，一直是畜禽预防传染病的最有效的武器，国家历来把兽用生制品的监督管理作为兽药管理的重中之重。但是随着养殖业的飞速发展，疫苗的使用量不断增大，作为特殊的兽药，生物制品的利润相对较高，因此与生物制品生产、经营相关的企业为了获取最大利润，常常是置国家法律、法规于不顾，给养殖业及公共卫生安全带来了极大隐患。     

解读《兽用生物制品经营管理办法》

兽用生物制品质量关系到动物疫病防控，关系到畜牧业持续稳定健康发展，关系到食品卫生安全，更关系到公共卫生安全和生物安全，所以应当对其严格管理。农业部一贯重视兽用生物制品管理工作，1996年4月25日发布了《兽用生物制品管理办法》（农业部令第6号），2001年9月17日对其进行了修订并发布了2号令，2004年11月1日根据《中华人民共和国行政许可法》规定予以废止。2004年11月1日施行的《兽药管理条例》，对兽用生物制品管理提出了一些新的要求。《兽药管理条例》规定，对兽用生物制品实行批签发管理制度，对强制免疫所需兽用生物制品实行定点生产制度，同时授权农业部制定强制免疫兽用生物制品经营管理办法。关于兽用生物制品生产环节的管理，由《兽药生产质量管理规范》、《兽用生物制品批签发管理办法》等办法规范和明确。但是，由于兽用生物制品具有对储存、运输条件要求严格的特性，所以，加强兽用生物制品经营环节管理，对保证兽用生物制品质量，保证动物疫病防控工作有效开展具有重要意义。正是基于这些考虑，农业部根据《兽药管理条例》规定，制定了《兽用生物制品经营管理办法》，对兽用生物制品的经营行为进行规范和管理。     

关于进口兽用生物制品监管方面的思考

自2007年《兽药进口管理办法》实施以来,我国在进口兽药管理方面取得了重要进步,但在进口兽用生物制品方面仍存在监管盲区。部分执法人员对进口兽用生物制品的范围、种类、经销关系等认识不足,导致监管思路不明确,执法浮于表面,存在监管漏洞。本文分析了进口兽用生物制品的范畴、国内市场种类、经销主体及经销关系,提出了进口兽用生物制品的基层执法思路,并对进口监管方面存在的问题进行了讨论,以期为优化进口兽用生物制品监管政策提供参考。     

2005年后我国兽用生物制品业面临的选择

改革开放以来我国畜禽疫病得到了有效的控制，畜产品质量与产量显著提高。畜禽疫病的防制离不开兽用生物制品，兽用生物制品质量的好坏直接影响畜禽疫病的防疫工作，我国政府十分重视兽用生物制品的质量，加强了对兽用生物制品的研制、生产、经营、进出口、使用和监督管理工作。农业部已规定2006年1月1     

《兽用生物制品管理办法》即将实施

为了提高兽用生物制品的质量和防疫效果,进一步加强兽用生物制品的管理工作,农业部常务会议于1996年4月25日讨论通过了《兽用生物制品管理办法》,并已在今年10月1日正式实施。 此办法共分为总则、生产管理、经营管理、新生物制品管理、进出口管理、使用管理、质量管理、附则等8个部分,对兽用生物制品的生产、经营、进出口等作了明确规定。从生产、经营、使用的根源抓起,采用现代化手段堵塞漏洞,加强兽用生物制品的监督管理,必将有效扼制目前国内兽用生物制品生产、经营、使用混乱,假劣兽药     

兽用生物制品经营管理办法

第一条为了加强兽用生物制品经营管理,保证兽用生物制品质量,根据《兽药管理条例》,制定本办法. 第二条在中华人民共和国境内从事兽用生物制品的分发、经营和监督管理,应当遵守本办法. 第三条本办法所称兽用生物制品,是指以天然或者人工改造的微生物、寄生虫、生物毒素或者生物组织及代谢产物等为材料,采用生物学、分子生物学或者生物化学、生物工程等相应技术制成的,用于预防、治疗、诊断动物疫病或者有目的地调节动物生理机能的兽药,主要包括血清制品、疫苗、诊断制品和微生态制品等.     

Heartworm in dogs in Canada in 1984

In late December 1984, 1853 institutional veterinarians and small and mixed animal clinics across Canada were sent a questionnaire in order to assess the status of Dirofilaria immitis in Canada in 1984 and 35% of them responded. Veterinarians reported that 97,794 dogs were blood-tested to check for microfilariae and 1417 dogs (1.45% of those tested) were found with heartworm. Another 34 dogs were amicrofilaremic, but were diagnosed as having heartworm disease, to give the total number diagnosed in 1984 as 1451 (1.48%). Heartworm was reported from all provinces except Prince Edward Island and Newfoundland but most (1310) of the cases were in Ontario. In Quebec, 126 cases were reported mostly from west of Montreal.

Heartworm was found most frequently in companion dogs over three years of age maintained mainly outdoors in rural areas. About 27% of the cases were observed with clinical signs of heartworm disease and 72% had a history of not having left Canada. Southwestern Ontario continued to be the primary focus of the infection.

     

Heartworm in dogs in Canada in 1983

In late December 1983, 2 800 veterinarians across Canada were sent a questionnaire in order to assess the status of heartworm disease in Canada in 1983 and 26% of them responded. Veterinarians reported that 59 504 dogs were blood-tested to check for microfilariae and 771 dogs (1.30% of those tested) were found with Dirofilaria immitis. Heartworm disease was diagnosed in all provinces except New Brunswick and Newfoundland but most (733) of the cases were in Ontario.

Heartworm disease was found most frequently in companion dogs over three years of age maintained mainly outdoors in rural areas. About 31% of the cases were observed with clinical signs of heartworm disease and 64% had a history of not having left Canada. Southwestern Ontario continues to be the focus of the infection and most of the dogs there had not left the province previously.

     

Heartworm in dogs in Canada in 1991

In late November 1991, 1883 clinics in Canada were sent a questionnaire to assess the status of Dirofilaria immitis in dogs in 1991 and there was a 60.0% response. There were 344,031 dogs tested for heart-worm (HW), 627 were found infected and the prevalence of HW infection was 0.18%. There were 417 dogs with HW in Ontario, 116 in Manitoba, 38 in Quebec, 53 in British Columbia, three in Alberta, and one in Nova Scotia. In British Columbia, all of the infected dogs but one were from the Okanagan valley which, as from 1991, is a new focus of infection in Canada. Most dogs with HW had not been on preventive medication in 1990, and the prevalence among dogs tested and unprotected was 0.59%. That prevalence was considerably higher in endemic areas. Companion dogs, over three years of age and maintained primarily outdoors in rural areas, were most frequently infected. One cat was diagnosed with D. immitis and 33 dogs had Dipetalonema reconditium.     

Heartworm in dogs in Canada in 1985

In late December 1985, 1485 institutional veterinarians and small and mixed animal clinics across Canada were sent a questionnaire in order to assess the status of Dirofilaria immitis in Canada in 1985 and 44% of them responded. Veterinarians reported that 137,300 dogs were blood-tested to check for microfilariae and 1210 dogs were found with heartworm. Another 36 dogs were amicrofilaremic but diagnosed with heartworm disease to give the total number diagnosed in 1985 as 1247 (0.91%).

Heartworm was reported from all provinces except Prince Edward Island, Newfoundland and Saskatchewan but most (1126) of the cases were in Ontario. Southwestern Ontario continued to be the primary focus of the infection in Canada. From Quebec, 91 cases were reported mostly from and around Montreal. From Manitoba, 19 cases were reported from Winnipeg and surrounding areas. Heartworm was found most frequently in companion dogs over three years of age maintained mainly outdoors in rural areas. About 28% of the cases were observed with clinical signs of heartworm disease and 78% had a history of not having left Canada.

     

Heartworm in dogs in Canada in 1988

In late November 1988, 1581 small and mixed animal clinics and institutional veterinarians across Canada were sent a questionnaire in order to assess the status of Dirofilaria immitis in Canada in 1988, and 46% of them responded. Veterinarians reported that 181,577 dogs were blood-tested for heartworm disease and 367 dogs were found with D. immitis microfilariae. Another 60 dogs were amicrofilaremic but diagnosed with heartworm disease to give the total number of cases diagnosed in 1988 as 441 (0.24%).     

Heartworm in dogs in Canada in 1989

In late November 1989, 1732 clinics and institutional veterinarians were sent a questionnaire to assess the status of Dirofilaria immitis, and 51.7% responded. Of 247,716 dogs tested, 394 had D. immitis microfilariae and 51 were amicrofilaremic for a total of 445 cases and heartworm prevalence of 0.17%. Most (408) of these dogs had no preventive medication and the prevalence among dogs tested and unprotected was 1.01%. That prevalence was considerably higher in endemic areas. Thirty-seven dogs with heartworm had preventive medication. Heartworm was most frequent in companion dogs over three years of age maintained outdoors in rural areas. About 75% of the cases had never left Canada, 26% had clinical signs and 125 were not treated.

Heartworm was reported from British Columbia, Manitoba, Ontario, Quebec, Nova Scotia and Newfoundland, but 383 cases were in Ontario. South-western Ontario was the primary focus of infection. There were 33 cases in Quebec and 24 in Manitoba, mainly found in and around Metropolitan Montreal and Winnipeg respectively.

     

Heartworm in dogs in Canada in 1987

In late November 1987, 1246 institutional veterinarians and small and mixed animal clinics across Canada were sent a questionnaire in order to assess the status of Dirofilaria immitis in Canada in 1987, and 50% of them responded. Veterinarians reported that 165,428 dogs were blood tested for heartworm disease and 511 dogs were found with D. immitis microfilariae. Another 78 dogs were amicrofilaremic but diagnosed with heartworm disease to give the total number of cases diagnosed in 1987 as 589 (0.35%).     

Heartworm in dogs in Canada in 1986

In late December 1986, 1224 institutional veterinarians and small and mixed animal clinics across Canada were sent a questionnaire in order to assess the status of Dirofilaria immitis in Canada in 1986; 46% of them responded. Veterinarians reported that 150,989 dogs were blood-tested for microfilariae and 869 dogs were found with heartworm. Another 65 dogs were amicrofilaremic but diagnosed with heartworm disease and one was found with heartworm at necropsy to give the total number diagnosed in 1986 as 935 (0.62%).

Heartworm was reported from Manitoba, New Brunswick, Ontario and Quebec, but most (810) of the cases were from Ontario. South-western Ontario continued to be the primary focus of the infection in Canada. There were 103 cases reported from Quebec, mostly from and around Montreal, and 21 cases from Manitoba, from Winnipeg and surrounding areas. Heartworm was found most frequently in companion dogs over three years of age maintained mainly outdoors in rural areas. About 33% of the cases were observed with clinical signs of heartworm disease and 81% had a history of not having left Canada.