Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’

Stakeholder no.

Section No.

Comment and rationale

Proposed change / recommendation

of the prescription would be independent of the owner of the drug. (e.g. owned by the EMA) Key question: are there specific primary care related viewpoints on patient-focused drug development? The reflection paper starts with what seems a new paradigm – the patient’s perspective -. An immediate reaction could be early approval of medications and vaccines before completion of their clinical trials on clinical complications. But “patients’ perspective is also the relevance of safety and efficacy”. It is also difficult for primary care to communicate news of treatment when there is no consensus and potentially growing uncertainty, with fear of potential new disruptions to come. Since the Covid pandemic started we have learned more about the disease and diagnosis regarding treatment, similarly to when HIV started and within a decade became a treatable condition and patients are safely managed as any other chronic diseases. Patients group were part of developing treatment. Covid19 also brings its new cultural stigma, - elderly and isolation - . The progress in understanding the disease came with its set of constraints. The EU has got an existing system that provide feedback, the current dilemma is: it must be timely and in full details but on the other hand provided as quick as possible. Patients’ cultural needs, and specific understanding of symptoms or value are part of primary care work, which is sometimes helped with sociology ethnology or

Overview of comments received on 'ICH reflection paper on proposed ICH guideline work to advance patient focused drug development’ (EMA/CHMP/ICH/415588/2020) EMA/194133/2021

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