Cancer patent in bed with doctor by her side explaining something in her notes

The EMA guidance is always invaluable when designing a clinical development program for products destined for the European market, and useful when preparing for Scientific Advice.
We have until February 15th to make comments on two related guidance documents from the EMA.

First, the pending 6th revision of the EMA guidance on Clinical Evaluation of Anticancer Medicinal Products can be seen here.

The previous revision focussed on the collection and reporting of safety data and its effect on the benefit-risk evaluation. This revision updates the guidance on oncology study design, such as “master protocols” where more than one investigational drug and/or more than one oncology indication is addressed within the same overall trial structure, i.e. umbrella and basket trials. It also deals with the use of biomarkers to identify an appropriate target population.

Additionally, an appendix is being prepared on section 4.8 (the undesirable effects section) of the Summary of Product Characteristics (SmPC) for an oncology product. Take a look at this paper.

The EMA guidance on anticancer medicinal products is grouped together on their website.

Contact us at Agos Pharma for help if needed.

#SME #regulatoryaffairs #EMA #Oncology #ScientificAdvice #Protocol Assistance #MAA

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