India Preparing for the Issuance of Written Confirmations

GmpForEver

As of 2 July 2013 each consignment of APIs to Europe must be accompanied by a written confirmation. This document shall prove the GMP compliance of the APIs delivered. Moreover, the exporting country has to control the API manufacturers concerned according to the EU GMP Standard (ICH Q7 or an equivalent standard). In many countries where APIs are manufactured, there are neither GMP requirements equivalent to those established in the EU nor systems suitable to the monitoring of API manufacturers. Today, the most significant manufacturing countries are India and China. Since the publication of the new requirements regarding the Written Confirmation on GMP Compliance concerns have been expressed that China and India won't be able to deliver all APIs to Europe. This would have a huge impact on the manufacture of medicinal products in Europe as many APIs aren't manufactured in Europe any longer.

The Indian website "Drug Regulations" reported on 14 January about the first concrete steps regarding Written Confirmations taken by India. The article quotes a statement made by the Pharmaceutical Export Promotion Council of India according to which the EU authorities have been informed by the Embassy of India about the designation of the Central Drug Standards Control Organization (CDSCO) as competent authority of India for the purpose of issuing the Written Confirmations. Reports were already published in September 2012 regarding this step. At that time, the Pharmaceuticals Export Promotion Council of India released an "Important Clarification" containing the announcement of this step which is now achieved.

Yet, the designation of a competent authority is only a small step. Indeed, India has to comply with a range of requirements to be able to issue Written Confirmations - among other things GMP requirements equivalent to those established in the EU and regular monitoring. In addition, the Indian authority have to inform immediately the respective EU authorities about major deviations observed during GMP inspections regarding GMP non-compliance. As the Indian GMP requirements are not equivalent to the European ones, it seems almost impossible to issue Written "GMP" Confirmations.

静夜思雨

建议也贴出中文哦。{:soso_e113:}

GmpForEver

静夜思雨 发表于 2013-2-8 13:57
建议也贴出中文哦。

翻译了一下大概意思：
自2013年7月2日，所有出口到欧盟的API都有附带一个“书面确认函”，这个函证明符合GMP。出口国必须按EU-GMP控制原料药的生产。但在一些API生产国家，没有等同的GMP要求和系统。作为原料药出口大国中国和印度，也必须出具这个书面确认函，否在就不能再往欧盟出口API。在印度的药品法规网站上，印度药品出口促进协会已经按照欧盟要求，印度大使馆通知欧盟官方由CDSCO机构作为发放书面确认函的权威机构。然而这只是一小步，实际上，印度官方必须立即通知EU官方一些GMP检查不符合项涉及的一些主要问题。因为印度GMP要求与欧盟的不能等效，看起来发放书面的GMP确认函是不太可能的。

youngzhou

谢谢楼主分享

静夜思雨

GmpForEver 发表于 2013-2-8 14:30
翻译了一下大概意思：
自2013年7月2日，所有出口到欧盟的API都有附带一个“书面确认函”，这个函证明符合 ...

谢谢！祝新年快乐！

大奕贻

看帖子的都发表一下看法












武破乾元