The European Medicines Agency has released for public consultation the concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals.

The European Medicines Agency has released for public consultation the concept paper on the development of guidance on the non-clinical evaluation of radiopharmaceuticals.

The development and marketing authorisation of radiopharmaceuticals are regulated by the Directive 2001/83/EC for medicinal products for human use. Radiopharmaceuticals include radiodiagnostic as well as radiotherapeutic agents. Currently, there is no detailed guidance available specifically addressing non-clinical testing of radiopharmaceuticals other than the regulation of dosimetry (Directive 96/29/Euratom and 97/43/Euratom). Therefore, in addition to the general non-clinical requirements described in ICH M3(R2), ICH S9 and ICH S6(R1), the need for guidance expanding on the principles for non-clinical data generation in support of the specific clinical uses of radiopharmaceuticals was deemed appropriate.

The document open for consultation is available by clicking here.

Comments should be provided using this template.

The completed comments form should be sent to swp-h@ema.europa.eu.

Please note that the deadline for comments is 31. October 2017.

Please note that EMA may collect and further process some personal data of stakeholders and interested parties who submit contributions to the consultations. For more information, see Specific privacy statement for public consultations.

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With kind regards,

Ivan Sebest

Stakeholders and Communication Division

European Medicines Agency

30 Churchill Place

London, E14 5EU

United Kingdom