Overview:

European Medicines agency (EMA) updates their executive decision for orphan drug development of waiving fees for academic organization. This update is a part of EMA’s 2017 collaboration with the academia which became eligible from 19th June 2020.

Prior to this incentive, fees imposed before the update ranged from €44,400 to €89,000 for initial scientific advice. For follow-up scientific advice it ranged from €22,400 to €44,400. Fees reduction for scientific services are provided under article 7 of Regulation (EC) 2049/2005 on SMEs.

Fee Reduction Incentives 

Protocol assistance

100% reduction to the total applicable fees

Scientific services

100% reduction to the total applicable fees

Inspections (Pre-Authorization)

100% reduction to the total applicable fees

Application for a MA

100% reduction to the total applicable fees

Post- authorization activities

100% reduction to the total applicable fees

Inspections (Pre-Authorization)

90% reduction to the total applicable fees

Eligibility

Both public and private institutes of higher education who award academic degrees and conduct research are eligible for fees waiver. For eligibility, the organization should not have a final agreement with a pharmaceutical company for sponsorship.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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