Safety and Quality Assurance

ONO's Drug Reliability
Assurance Activities

From a patient standpoint, ONO conducts drug reliability assurance activities with global perspective through drug life cycle to constantly check for drug quality assurance and reflect opinions from healthcare professionals and patients on further quality improvement. In addition, we analyze and assess, based on latest scientific evidence, drug quality and efficacy and safety (adverse reaction) information collected from, e.g., reports from patients and healthcare professionals, literature, and surveys, to constantly provide updates to the frontline of healthcare.

Quality Assurance Policy

We not only meet the legal requirements as a marketing authorization holder, but also set out our own quality manual to establish a drug quality system and work to continuously improve systems so as to provide high-quality drugs from the viewpoints of patients, caretakers and healthcare professionals. In addition, we contribute to society through stable supply of pharmaceuticals that are assured to a high-quality standard.

Initiatives for Proper Use of Pharmaceuticals

We develop a risk management plan and collect and manage safety (adverse reaction) information for each pharmaceutical.
We assess collected data and information, and if necessary revise the cautions on package inserts and make announcements about proper use.
As safety information drastically increases inside and outside Japan after market launch of antineoplastic drugs, we assess such information based on opinions from external medical experts to promote the proper use of the drugs, e.g., by disseminating it through promotional materials, conference presentations, and medical journals.
In addition, the Corporate Regulatory Compliance Safety and Quality Assurance Division, containing a section responsible for data, also uses and utilizes medical databases to analyze pharmaceutical product profiles and safety information for proper use.

Maintenance of Product Recall System

We have a system in place to recall any products with efficacy, quality or safety problems and to promptly provide medical professionals with information on them. We also have relevant departments jointly conduct periodical drills in preparation for product recall to check that they can be executed quickly even in unexpected circumstances.