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3月6日,从中国医药设备工程协会2013年年会上获悉,目前国家药品监督管理部门已初步确定,将以省为单位出具原料药出口欧盟证明文件,并对出口欧盟的原料药划定了监管范围,以应对今年7月2日正式实施的欧盟有关原料药进口的62号令,具体实施办法有望于3月底发布。出口监管升级2011年6月,欧盟通过了一项有关原料药进口的新指令2011/62/EU(62号令),要求出口到欧盟的原料药的国家或地区的监管部门必须出具生产企业每一批次产品均符合欧盟GMP标准的书面证明。该指令被国内原料药界视为具有重大“杀伤力”的外贸政策之一。中国医药保健品进出口商会相关数据显示,目前,我
March 6, learned from the annual meeting of China Pharmaceutical Equipment Engineering Association in 2013, at present, the State Drug Administration has tentatively determined that it will issue a certificate of export of raw material medicine to the EU on the provincial level and delineate the raw material drugs for export to the EU The scope of supervision in response to July 2 this year, the EU formally implemented the import of raw materials related to the 62nd order, the specific implementation measures are expected to be released by the end of March. Export Regulatory Upgrading In June 2011, the EU adopted a new Directive 2011/62 / EU on the import of bulk drugs (Decree 62), requiring regulators in the countries or regions that export to the European Union (EU) Batch of products are in line with the EU GMP standard written proof. The directive is regarded as one of the major “lethal” foreign trade policies by the domestic pharmaceutical raw material industry. China Medicines & Health Products Import and Export Chamber of Commerce data show that at present, I