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[欧盟药事] 印度块进一步扩大非物质文化遗产的协调India blocks further Expansion of the ICH...

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药徒
发表于 2014-7-15 13:55:06 | 显示全部楼层 |阅读模式

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印度块的进一步扩大,因此国际协调会议(ICH)的成功。再加上一些患者群体,国家要避免世界卫生组织(WHO)将继续参与非物质文化遗产的过程。
非物质文化遗产是已经提交到监管标准的制药行业协调组织。它成立于1990年,成员包括美国(FDA),欧洲(EMA/欧盟委员会)和日本(厚生劳动省)药品监督管理机构以及三个区域协会(PhRMA,EFPIA,JPMA的行业协会)。世界卫生组织,欧洲自由贸易联盟(EFTA)和加拿大卫生部参加所谓的观察员。制药厂商和协会联合会(IFPMA)的指导委员会表示为无投票权成员。
公司自成立以来,非物质文化遗产一直是一个成功的故事。虽然最初只规定了统一的是相关的市场营销授权/批准的药物,一些GMP的有关文件在质量领域的后来发展为好。这些措施包括ICH Q7(GMP原料药),ICH Q8药物开发(由设计质量),ICH Q9质量风险管理,Q10药品质量体系和ICH Q11开发和生产原料药,这是所有与GMP相关​​的协调要求。这完成了统一的质量方针的范围广泛,与第一季度开始稳定,并继续与Q2分析验证,杂质Q3,Q4药典,生物技术产品和Q6规格Q5的质量。此外,还有在其他领域,如安全性和有效性的统一准则。
印度现在阻止世卫组织持续成功的统一是惊人的第一眼。毕竟,它必须在所有国家的利益,以确保高的药品安全标准,以阻止各国建立自己的法规而带来安全收益,但会增加药物的费用。
印度支持通过各种病人群体的努力。批评是,除了当局还行业组织的代表在ICH指导委员会(如上文所述)。因此,印度怀疑脑出血统一的滥用。推理背后是ICH可能建立标准,只帮助了世界领先的制药公司,以保护他们的药物对来自第三世界的低成本替代品。
其中在对非物质文化遗产这一举措组批评也是印度中央药品标准控制组织(CDSCO)。这很有趣,因为这个组织被批评就产生了所谓的确认书(GMP符合性声明导入药物进入欧盟)。而从欧盟和FDA检查员印度业务进行了多次检测到严重的GMP问题,CDSCO还公布笔试(GMP)在其网站上的确认(根据ICH Q7或同等学历)对于已经评定为不符合GMP标准的同样公司。同样的组织现在认为,ICH的标准太高。
根据患者组世界医师组织和人民健康运动的许多非物质文化遗产制定的标准不添加的药品质量保证的任何值,只会增加生产医药产品的成本。
这将是多不幸,如果ICH协调努力减缓由于这一倡议。非物质文化遗产提供给病人的安全做出了巨大贡献。非物质文化遗产的努力和标准导致对药物降低监管成本。批评者还欠证明,ICH法规人为地提高标准。这将是致命的,如果该标准的药物安全性会在一些国家被下调之下那些在ICH地区。
资料来源:印度时报的文章:印度阻挠大型制药企业推动世卫组织集会


India blocks the further expansion and therefore the success of the International Conference on Harmonisation (ICH). Together with some patient groups, the country wants to avoid that the World Health Organisation (WHO) continues to be involved in the ICH process.
The ICH is an organisation that has committed to the harmonisation of regulatory standards in the pharmaceutical industry. It was founded in 1990. Members are the drug regulatory agencies in the United States (FDA), in Europe (EMA/EU Commission) and in Japan (MHLW) as well as the industry associations of the three regions (PhRMA, EFPIA, JPMA). The WHO, the European Free Trade Association (EFTA) and Health Canada take part as so-called observers. The International Federation of pharmaceutical manufacturers & associations (IFPMA) is represented in the Steering Committee as a non-voting member.
Since its inception, the ICH has been a success story. While initially only rules were harmonised that were relevant for marketing authorisation/drug approval, a number of GMP relevant documents in the area of quality were developed later as well. These include ICH Q7 (GMP for APIs), ICH Q8 Pharmaceutical Development (Quality by Design), ICH Q9 Quality Risk Management, Q10 Pharmaceutical Quality System and ICH Q11 Development and Manufacture of Drug Substances, which are all relating to the harmonisation of GMP relevant requirements. This completed the extensive range of harmonised quality guidelines, beginning with Q1 Stability and continued with Q2 Analytical Validation, Q3 Impurities, Q4 Pharmacopoeias, Q5 Quality of Bio-technological Products and Q6 Specifications. In addition there are harmonised guidelines in other areas such as safety and efficacy.
That India now prevents the WHO from continuing the successful harmonisation is amazing at first glance. After all, it must be in the interest of all countries to ensure a high drug safety standard and to prevent countries from establishing their own regulations which bring no security gain but increase the cost of medicines.
India is supported in its efforts by various patient groups. The criticism is that in addition to authorities also industry organisations are represented in the ICH Steering Committee (as stated above). Thus, India suspects a misuse of ICH harmonisation. The reasoning behind is that ICH might establish standards that help only the world's leading pharmaceutical companies to protect their drugs against low-cost alternatives from the third world.
Among the group of critics in this initiative against ICH is also the Indian Central Drug Standard Control Organisation (CDSCO). This is interesting because this organisation was criticised with regard to generating the so-called Written Confirmations (GMP Compliance Statement for importing drugs into the EU). While repeatedly severe GMP problems were detected in Indian operations from EU and FDA inspectors, the CDSCO still published Written (GMP) Confirmations on their website (based on ICH Q7 or equivalent) for the same companies that were already evaluated as non-GMP compliant. That same organisation now argues that ICH standards are too high.
According to the patient group Medicus Mundi and People's Health Movement many ICH established standards do not add any value for the quality assurance of medicines and only increase the costs for the production of medicinal products.
It would be more than unfortunate if ICH harmonisation efforts slowed down due to this initiative. The ICH provided an enormous contribution to patient safety. ICH efforts and standards resulted in reduced regulatory costs for medicines. Critics still owe proof that ICH regulations artificially raise standards. It would be fatal if the standards for drug safety would be lowered in some countries beneath those in ICH regions.
Source: The Times of India article: India thwarts Big Pharma push at WHO assembly
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药徒
发表于 2014-7-15 13:57:04 | 显示全部楼层
这是得有多脑残?
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药徒
发表于 2014-7-15 14:43:59 | 显示全部楼层
楼主这是要闹哪样
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药士
发表于 2014-7-15 15:35:01 | 显示全部楼层
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药生
发表于 2014-7-19 20:47:10 | 显示全部楼层
好吧,印度人嫌ICH标准协调的太高。   
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药徒
发表于 2014-7-20 20:35:37 | 显示全部楼层
这个是什么题目啊
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大师
发表于 2014-7-20 20:50:56 | 显示全部楼层
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