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Adjusted fees for EMA applicants from April 1st

4月1日起EMA申请费用调整

European Pharmaceutical Review

5 March 2019

The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders, (the company or other legal entity that has the authorisation to market a medicine in one, several or all European Union Member States), that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2019.

欧洲药品管理局（EMA）提醒申请人和营销授权持有人（有权在一个、多个或所有欧盟成员国销售药品的公司或其他法人），除药物警戒程序外，所有申请的调整费用将于2019年4月1日生效。

The EMA’s definition of pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem.

EMA对药物警戒的定义是：与检测、评估、理解和预防不良反应相关，或与防止副作用和其他药物相关问题有关的科学活动。

Every year, the European Commission adopts a regulation adjusting the fees payable to the Agency with reference to the inflation rate in the European Union for the previous year. The 2018 inflation rate was 1.7 percent.

每年，欧洲委员会都会根据上一年的通胀率，通过一项法案，来调节支付给机构的费用。2018年通货膨胀率为1.7%。

The EMA will publish full details of the revised fees at the end of March, once the regulation has been adopted by the European Commission and published in the Official Journal of the European Union,which publishes legal instruments and other European Union documents. The Agency’s Management Board will decide on the implementation of the regulation at its March 2019 meeting.

欧洲管理局将在3月底公布修订后费用的全部细节，一旦该条款被欧洲委员会通过并在《欧盟官方公报》（专门公布法律文书和其他欧盟文件）上公布。该机构的管理委员会将在其2019年3月的会议室决定该条例的实施。

Fees charged for pharmacovigilance procedures in accordance with Regulation (EU) 658/2014 are expected to be revised in 2020, taking into account the 2018 and 2019 inflation rates.

根据条例（欧盟）658/2014，对药物警戒程序收取的费用预计将在2020年进行修订，该调整将同样考虑2018年和2019年的通货膨胀率。

本文内容取自 European Pharmaceutical Review

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