TGA加入EDQM的CEP评估过程

清歌一曲月如霜

澳大利亚治疗产品管理局（TGA）设置为加强与欧洲局合作的药品和保健管理局（EDQM）的质量。
在2014年5月澳大利亚被接纳为EDQM的程序适用性的欧洲药典（CEPS）的专着认证的评审员。
该认证程序CEP证书的专着评估是否适合来控制化学纯度，微生物质量和传染性海绵状脑病（TSE）的风险（如相关），用于覆盖了欧洲药典专论的任何物质。
TGA陪审员将参与提交的厂家，获得CEP应用的科学评估。这将使澳大利亚与我们的国际同行领先，以更明智的和一致的监管决定在国际上共享信息，技能和经验。
澳大利亚是少数几个国家，承认CEP证书在其评估过程的仿制药的欧洲成员国以外之一。与来自不同司法管辖区的监管机构制定共同的标准一起工作，指导和监管要求将减少向市场推出的治疗产品，确保澳大利亚人及时获得高质量的药品的时间。
来源：
TGAThe Australian Therapeutic Goods Administration (TGA) is set to strengthen its collaboration with the European Directorate for the Quality of Medicines and HealthCare (EDQM).
In May 2014 Australia was accepted as an assessor in the EDQM's procedure for the Certification of Suitability to the monographs of the European Pharmacopoeia (CEPs).
The certification procedure for CEPs assesses the suitability of monographs to control the chemical purity, microbiological quality and transmissible spongiform encephalopathy (TSE) risk (if relevant) for any substance covered by a European Pharmacopoeia monograph.
TGA assessors will take part in the scientific assessment of applications submitted by manufacturers to obtain a CEP. This will allow Australia to share information, skills and experience with our international colleagues leading to more informed and consistent regulatory decisions internationally.
Australia is one of a handful of countries outside of European member states that recognises CEPs in its evaluation processes for generic medicines. Working together with regulators from different jurisdictions to develop common standards, guidelines and regulatory requirements will reduce the time to market for therapeutic products ensuring Australians have access to quality medicines in a timely manner.
Source:
TGA

郝小琴

TGA是明智di，谢谢蒲友的分享。

冰城

很晦涩啊，了解下

syhorchid

值得借鉴