Concept Paper on the Establishment of a Guideline on the Development and Manufacture of Synthetic Oligonucleotides

On 16 September 2022 the EMA published the draft guidance for consultation from 20 September 2022 to 20 December 2022.

This concept paper addresses the need to establish a Guideline on the Development and Manufacture of Synthetic Oligonucleotides. The number of clinical trial applications for human products and marketing authorization applications for synthetic oligonucleotides for both human and veterinary products has significantly increased over the last few years.

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