Quality and Reliability Assurance Division

Ensuring the reliability of the Taiho brand worldwide and protecting the safety of patients everywhere

Pharmaceutical products contribute best to the treatment of patients when used in an appropriate dose and manner and must be delivered to patients with consistent quality levels in compliance with pharmaceutical regulations and related laws in and outside Japan. It is also important to conduct accurate data collection and analysis on whether the expected benefits and safety are being demonstrated in treated patients and to facilitate further safe and proper use of the pharmaceutical products through prompt feedback of safety information to clinicians and patients. For these reasons, a pharmaceutical manufacturer has an important responsibility towards patients, healthcare professionals and all people to ensure that pharmaceutical products and product information are at proper quality levels.

Taiho's Quality and Reliability Assurance Division, working to realize Taiho's corporate philosophy — "We strive to improve human health and contribute to a society enriched by smiles" — carries out a variety of pharmacovigilance and quality assurance activities from a global perspective throughout the product life cycle, from research and development through marketing application submission and approval to market launch and beyond, in order to deliver high-quality pharmaceutical products and product information to patients and healthcare professionals worldwide. Specific pharmacovigilance and quality assurance activities are carried out mainly by the following four departments in close cooperation. The members of these departments work day in and day out to ensure that world-class Taiho brand products make a difference for patients worldwide.

Regulatory Affairs Department

The Regulatory Affairs Department monitors various regulatory trends related to pharmaceutical products and medical care in and outside Japan and provides advice and directions to other departments to ensure compliance with pharmaceutical regulations and related legislation. With its regulatory expertise, the department is also directly involved in various areas including development, marketing application, post-marketing research, and surveillance policies with implementation of immediate and accurate regulatory compliance throughout, from pharmaceutical development to market launch and beyond on a global scale.

Plant Quality Assurance Department

The Plant Quality Assurance Department verifies that product quality is being ensured in an appropriate manner and also translates voices of clinicians and patients into improvement of product quality to ensure delivery of safe, high-quality pharmaceutical products to patients worldwide. In order to accomplish this responsibility, the department ensures that products from Taiho production sites worldwide are manufactured and shipped to the market under appropriate quality management systems in accordance with Taiho’s quality policy and the laws and regulations in and outside of Japan. The department makes continuous effort in leading and improving Taiho’s production processes. It also assures product quality through close cooperation with pharmaceutical raw material suppliers in and outside of Japan as well as through close interdepartmental cooperation.

Clinical and Research Quality Assurance Department

The Clinical and Research Quality Assurance Department verifies appropriateness of implementation and operation of Taiho's quality assurance system in light of pharmaceutical regulatory requirements and relevant legislation with strict standard in and outside Japan through conducting various types of audits as well as through providing awareness, direction, and education internally. Through these activities, the department ensures Taiho's reliability as a global company.

Pharmacovigilance Department

The Pharmacovigilance Department conducts assessment of the balance between risks and benefits of Taiho brand products at every stage of pharmaceutical life cycles from clinical development to on-market stages based on analysis of data collected from various sources ranging widely from pharmaceutical basic research to healthcare professionals, patients, and other individuals. The department reaches out to patients to promote and manage proper use of Taiho products in cooperation with other related departments as well as with affiliates and partners worldwide.