MFDS to Incorporate Patient Voices into New Drug Reviews... Establishes Guideline

Taking Quality of Life and Treatment Preferences into Account

Going forward, when reviewing applications for drug approval, regulators will use “patient experience” as a basis for evaluation, including the impact of a disease as experienced by patients themselves and their treatment preferences. The aim is to reflect patients’ actual needs, which cannot be captured by clinical trial data alone, in the development and approval of new drugs.

Ministry of Food and Drug Safety in Cheongju, North Chungcheong Province. The Asia Business Daily database.

On October 30, the National Institute of Food and Drug Safety Evaluation, under the Ministry of Food and Drug Safety, announced that it had established the “Guideline on Drug Approval and Review Based on Patient Experience Data.” Patient experience data refers to information capturing the experiences of patients and caregivers, including how a disease or treatment affects patients’ lives and their treatment preferences.

The guideline outlines the main types of patient experience data and how they can be used. Examples include patient-reported outcomes, in which patients report their own health status and quality of life; patient preference studies; patient engagement activities; and observational studies conducted through surveys. It also provides recommendations on how such data can be used at each stage, from early development through post-marketing, and considerations for generating and analyzing the data.

The data collected in this way will be used to supplement the evidence for assessing the benefits and risks of the clinical data that pharmaceutical companies submit with their approval applications. In developing the guideline, the Ministry of Food and Drug Safety gathered feedback through a collaborative framework involving the industry, academia, and patient groups.

A Ministry of Food and Drug Safety official said, “We expect this guideline to make it easier for companies to anticipate how they can use patient experience data. We also expect that incorporating the voices of diverse patients into approval reviews will improve the quality of regulatory decisions and help the development of new drugs for rare diseases, where treatment options are limited.”

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