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Business & Regulation Standards & Regulation

Pro Bono Advice

Developers of potential therapeutics or vaccines for COVID-19 have been invited to contact the EMA as soon as possible to take advantage of the full fee waiver the agency is offering for fast-tracked scientific advice applications. The agency will identify products mature enough to benefit from the fast-track advice service, which includes preliminary informal comments, feedback on development programs as well as guidance on best methods, study designs, and the efficacy and safety of products.

In addition to the fast-track scientific advice service, the EMA also reminds drug companies that it has several other measures that can speed up the development of pertinent medicines, including the PRIME scheme (originally launched to enhance support for the development of medicines that target an unmet medical need), accelerated assessment, and conditional marketing authorization procedures.

The EMA is also working closely with other international regulatory bodies to identify effective therapeutics with prophylactic effects.

Further details

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About the Author

Maryam Mahdi

Associate Editor

After finishing my degree, I envisioned a career in science communications. However, life took an unexpected turn and I ended up teaching abroad. Though the experience was amazing and I learned a great deal from it, I jumped at the opportunity to work for Texere. I'm excited to see where this new journey takes me!

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