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India blocks further Expansion of the ICH Harmonisation
印度阻挠ICH统一化进一步延伸
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.
印度阻挠ICH的进一步扩大和成功。印度与一些患者组织一起，想要避免WHO继续涉入ICH进程。
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.
ICH是一个制药行业的法规标准协调组织，它创建于1990年，成员是美国、欧洲和日本药监局（FDA、EMA/EU委员会、MHLW），以及三地区的行业联合会（PhRMA, EFPIA, JPMA）。WHO、欧洲自由贸易联合会（EFTA）和加拿大卫生局参加作为观察方。制药企业国际联合会（IFPMA）作为筹委参加，不具有投票权。
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.
自其创始，ICH就非常成功。开始只是与上市许可/药品批准相关的一些法规被统一，后来建立了大量的GMP质量相关文件，其中包括ICH Q7（原料药GMP）、ICH Q8 药品研发（质量源于设计）、ICH Q9 质量风险管理、Q10 药品质量体系和ICH Q11 原料药研发和生产，都是与GMP相关要求统一有关的。这些指南在很宽的范围内统一了质量指南，从Q1 稳定性到Q2 检验方法验证、Q3 杂质、Q4 药典、Q5生物技术药品的质量和Q6质量标准。另外，还有其它方面的统一指南，如安全性和有效性。
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.
现在印度阻止WHO持续这些成功的统一活动，乍看似乎很令人吃惊。不管怎么说，统一是有利于所有国家保证其药品的具有较高的安全标准，防止有些国家建立其自己的法规，带来不安全因素，但是肯定会增加药品成本。
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.
印度这些行为得到许多国内患者组织的支持。批评的言论认为，除了药监局外，企业组织也是ICH筹委会的成员（如上所述）。因此，印度质疑ICH协调活动被滥用。其背后的原因是ICH可能会建立标准，只有助于世界领先的药企，保护其药品不受到来自第三世界国家低成本替代产品的冲击。
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.
印度中央药品标准控制组织（CDSCO）也在这些反对ICH倡议组织中。这是很有意思的，因为该组织刚刚因为出具所谓“书面证明”受到批评。即使欧盟和FDA检查官在印度的生产场所中重复发现严重的GMP问题，被认为是不符合GMP，CDSCO仍在其官网上公布着这些企业的书面证明。现在就是这个组织，居然辩称ICH标准太高了。
根据患者组织MEDICUS MUNDI和人民健康运动的说法，ICH建立的许多标准并未增加药品质量保证，只是增加了药品的生产成本。
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.
如果ICH协调的努力因此而放慢脚步，就不仅仅是不幸了。ICH对患者安全贡献巨大，ICH的努力和标准减少了药品法规成本。批评者无法证明ICH法规人为地抬高了标准。如果某些国家的药品安全标准降低至低于ICH区域的标准，会带来致使的后果。
来源：印度时报文件：印度阻挠大型制药公司在WHO推行ICH
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发表于 2014-7-24 22:09:48
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