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上海義森生物有限公司:克霉唑雜質(zhì)B

2012

The eTACT project, the EDQMs’ anti-counterfeiting traceability service for medicines was launched. Ukraine became the first country to ratify the Medicrime Convention and the 38^th Member of the European Pharmacopoeia Convention and the Republic of Guinea and Singapore received observer status. The ISO 9001:2008 certificate was extended to cover the management of the elaboration, revision, correction and suppression of European Pharmacopoeia texts, their publication in printed and electronic format, as well as their distribution.

2011
On 24 June 2011, The EDQM signed a trilateral Memorandum of Understanding （MoU） with the State Administration of Traditional Chinese Medicine of the People's Republic of China （SATCM） and its National Key Institute of TCM Quality Control （NKI-TCM）.
The ISO 9001:2008 certificate was extended to the market surveillance of finished medicinal products and issuance of guidelines for the release of human immunological and blood derivative medicinal products.

2010
Memorandums of Understanding are signed with the National Institute of Food and Drug Safety Evaluation （NIFDS）, Korea Food and Drug Administration, and the Chinese National Institute of Food and Drug Control （NIFDC）, respectively.

The EDQM takes over responsibility for the establishment, preparation, storage and distribution of WHO International Chemical Reference Substances （ICRS）.

英國政府化學(xué)家實(shí)驗(yàn)室（Laboratory of the Government Chemist, LGC）成立于1842年，迄今已有近170年的歷史。自1870年以來，LGC即為法定的英國政府化學(xué)實(shí)驗(yàn)室，是食品安全領(lǐng)域政府和業(yè)界糾紛案件的法定仲裁者。LGC標(biāo)準(zhǔn)品公司是LGC有限公司重要組成部分，也是歐洲zui綜合全面的標(biāo)準(zhǔn)物質(zhì)提供者。LGC醫(yī)藥雜質(zhì)標(biāo)準(zhǔn)品不僅可用于藥物成分及劑型中雜質(zhì)的鑒別與控制，為藥物的申報(bào)與審批過程提供詳實(shí)可靠的數(shù)據(jù)，同時(shí)也用于分析方法的建立與驗(yàn)證，緊密地參與例行的質(zhì)控管理過程。