什么是中国兽药管理程序中主要的障碍

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What are the main obstacles in the Chinese vet med regulation process?

什么是中国兽药管理程序中主要的障碍

By Joseph Harvey

Published: 04 March 2015 10:54AM

In an ideal world, the approval process for veterinary medicines would beharmonized. However, this is not the case. Animal PharmEditor Joseph Harvey looks at the complicatedChinese regulatory system and how it differs from more familiar processesaround the globe.

在一个理想的世界，兽药的批准过程应该是和谐的。但是，这不是事实。Animal Pharm 编辑Joseph Harvey观察复杂的中国管理体系并和其与世界上众所周知的普遍程序有多么不同。

In April 2004, theState Council of the People's Republic of China released the Regulations onAdministration of Veterinary Drugs – a statute thatlargely still applies to this day following a review in 2013.

2004年4月，中华人民共和国国务院发布动物药品管理的相关法规（《兽药管理条例》）-该法规经过2013年的复审后至今仍然被广泛使用。

This regulationdecreed all new imported veterinary drugs to be registered with China's Centerof Veterinary Drug Evaluation, which part of the country's Ministry ofAgriculture (MOA) prior to entering Chinese market.

该法规规定所有的新的进口兽药在进入中国市场前，都必须在农业部的一个部门-中国兽药评审中心进行注册，

For veterinarydrugs to be imported to China for the first time, companies will need tosubmit:

对于第一次出口至中国的兽药，公司需要提交：

·        A document certifying the veterinary drugregulatory department of the country where the manufacturer is located hasapproved the production of the product

·        证明进口兽药已被兽药生产商所在国的兽药管理部门批准生产的相关文件。

·        A certificate issued by the veterinary drug regulatory department of thefirm's home country, certifying the drug conforms to the Good ManufacturingPractice regulations

·        由生产商所在国兽药管理部门颁发的，证明药品生产符合GMP法规的证书。

·        Data pertaining to method and process of manufacturing, quality standards,analytical method, results of pharmacological and toxicologicaltests, clinical trial reports and stability test reports

·        与制造方法和流程、质量标准，分析方法，药理学和毒理学试验结果、临床试验报告和稳定性试验报告相关的数据。

·        Data relating to withdrawal period, maximum residue limits, residueanalytical method and the basis for a veterinary drug used for food animals

·        与休药期、最大残留限度、药物残留分析方法和食品动物用兽药基础资料相关的数据

·        A sample copy of the label and package leaflet for the drug

·        药品标签和包装说明书的样本复印件。

·        A sample reference substance and standard substance of the drug

·        药品对照品和标准品样品。

·        The environmental impact report and measures for prevention and control ofpollution

·        环境影响报告和预防控制污染的措施

According to China'sChemical Inspection and Regulation Service (CIRS), when exportingveterinary biologics to China, applicants also need to provide the master seed bacteria(viruses or insects), cell lines and other relevantmaterials and data used in production – a key difference to Western regulatoryprocedures.

根据CIRS规定，当出口兽药生物制品至中国，申请者还需要提供原始种子菌（毒、虫），细胞系和其他生产用相关物料和数据—这是和西方管理程序最大不同。

Another importanthurdle, which has been a particularly difficult step for many companies aroundthe world, is the requirement that clinical trials for veterinary drugs need tobe carried out in China before the product can be sold there.

另一个重大的障碍（该障碍对于世界范围内许多公司也一直是一个特别困难的阶段）就是要求兽药产品在中国销售前，其临床试验必须在中国开展。

Authorities alsoneed the specific number of animals participating intrials to satisfy efficacy and safety requirements.

权威部门也需要特定数目的试验动物参与临床试验以满足药效和安全要求。

According to theMOA: "The documents should be provided with complete information, table ofcontents, page number, original test reports, original chromatograms and photosof test findings."

根据农业部规定：申请文件需要提供试验结果的完整的信息，目录、页数，原始试验报告，试原始图谱和照片。

Procedure list

程序表

According to theMOA, the procedure for registering a veterinary medicine in China is asfollows:

根据农业部规定：

1.   Acceptance of submitted documents

提交文件的接收

2.   Evaluation fee

评审费用

3.   Technical evaluation from the MOA Veterinary Drug Evaluation Center

农业部兽药评审中心技术检定

4.   Experimental evaluation – in light of suggestions made during thetechnical evaluation, the applicant needs to submit samples of the drug todesignated quality testing agencies

试验评定-根据技术检定中做出的建议，申请者需要提交药品样品至指定的质量检测机构

5.   Verification tests

核实检测

6.   On-site inspection

现场检查

7.   Approval issuance

批准发布

The estimatedpromised time frame of this process is 60 working days, with a maximum of 120 workingdays for technical evaluation or experimental evaluation, and a maximum of 150working days for special testing.

该流程估计的一般批准时限为60个工作日，最多120个工作日的技术检定或试验评审时限和最多120个工作日的特殊试验时限

According to theMOA, the registration charge for each product is RMB 6,000 ($960).

根据农业部的规定，每个产品的注册费用为6000人民币（960美元）.

Domestic regulatory preference forcing creation of JVs

China tends togive business and regulatory preferences to local manufacturers – the reasonwhy many major Western firms are forming joint ventures with Chinese companiesinstead of taking on R&D work entirely themselves.

中国倾向于给予本国生产企业商业和政策上的优惠——这也是为什么许多西方大公司和中国企业组建合资公司，而不是完全自己开展R&D工作的原因。

Many of theleading animal health companies based in the US or Europe have recently struckjoint venture deals with veterinary medicine manufacturers in China. Therefore,the firms avoid some of the rigorous Chinese regulations.

许多坐落在美国和欧洲领先动物保健公司最近已致力于和中国兽药生产企业建立合资公司，因此，这些公司避免了许多严厉的中国法规限制。

Zoetis has a team dedicated to pushing through product approval in China and thewider Asia-Pacific region.

Zoetis拥有一支团队致力于推动在中国和泛亚太地区的药品批准。

According to PhilipLehrbach, director of regulatory affairs in Asia Pacific for Zoetis,who spoke at last year's IBC Asia Animal Health conference: "We have two initiativesin China. One is our portfolio of imported products, which involves a lot ofcoordination for regulatory dossiers and stability data. The other is ourjoint-venture manufacturing site."

据Philip Lehrbach，Zoetis亚太法规事务主任，他在去年的IBC亚洲动物健康大会演讲所说：我们在中国有两套行动方案，一是我们的进口药品组合，其涉及许多法规文件和稳定性数据协调，另一个是我们合资生产基地。

In 2008, PfizerAnimal Health (now Zoetis)formed ajoint venture with Jilin Guoyan Animal Health, a developer ofveterinary vaccines based in Huinan County.

2008年，辉瑞动物保健（现在的Zoetis）和吉林Guoyan动保保健公司在惠南县组建了一专门从事兽药疫苗研发的合资公司

At the conference,Mr Lehrbach highlighted the regulatory process in China forveterinary products as a particularly difficult pathway. On an optimistic note,he said: "There are winds of change. There have beencries from the industry for a diversity of products. To do this we need toovercome differences with the authorities."

在大会上，Lehrbach先生强调中国兽药产品的法规程序是一个特别困难的过程。在乐观的氛围基调下，他说：“那里有了一系列改变，行业一直呼吁有多样化的产品，为了达到这个目的，我们需要克服和权威监管部门的差异。”

Full details ofthe MOA's 2009 Regulations on Administration of Veterinary Drugscan beviewed here. These regulations include provisions for R&D ofnew veterinary drugs, manufacturing, marketing and distribution.

关于农业部2009年兽药行政法规的详细资料可以在这里参阅。这些法规包括新兽药R&D，生产、市场销售和分销的条款。

Joseph Harvey |Editor, Animal Pharm

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