EMA to Give Free Advice to Academia Developing Treatments for Rare Diseases
The agency will be waiving fees for scientific advice for academia developing orphan drugs.
The European Medicines Agency (EMA) announced on June 23, 2020 that it would be waiving all fees for scientific advice for academia developing orphan medicines. The decision comes as part of the agency’s initiative to encourage the develop of treatments for rare diseases.
It is important for drug developers to interact with EMA early on in the process in order to understand regulatory requirements and ensure accurate evidence of a drug’s benefits and risks, according to the agency. Academia, however, has indicated to EMA that the fees for protocol assistance make it difficult to interact with the agency. EMA, therefore, has decided to include academia in its list of organizations that are eligible for free assistance, effective June 19, 2020.
Those that may qualify for free assistance include public or private higher education establishments that award academic degrees; public or private non-profit research organizations; or international European interest organizations. Applicants should not be financed or managed by private for-profit organizations in the pharmaceutical sector or have a concluded agreement with pharmaceutical companies regarding sponsorship or participation in a specific research project requesting fee exemption.
Source: EMA
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
