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. They also must be delivered to patients with consistent quality levels in compliance with pharmaceutical regulations and relevant laws in and outside Japan. It is also important to collect data accurately on whether the expected benefits and safety are being demonstrated in treated patients and analyze the data to facilitate further safe and proper use of the pharmaceutical products through prompt feedback of safety information to healthcare professionals and patients. A pharmaceutical manufacturer has an important responsibility to patients, healthcare professionals and all people to ensure that pharmaceutical products and product information are at proper quality levels.

The Quality and Reliability Assurance Division, working for realization of Taihoʼs 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. These activities are carried out mainly by the four departments listed at right, 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 trends in various pharmaceutical regulations and medical fields 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 involved in various areas including development, marketing application, post-marketing research, and surveillance policies to promote prompt and accurate regulatory actions 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 the voices of healthcare professionals 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 Taihoʼs quality policy and the laws and regulations in and outside of Japan. The department makes continuous effort in leading and improving Taihoʼs 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 Taihoʼs quality assurance system in light of pharmaceutical regulatory requirements and relevant legislation with strict standards in and outside Japan by conducting various types of audits as well as by providing direction, awareness and education internally. Through these activities, the department ensures Taihoʼs reliability as a global company.

Pharmacovigilance Department

The Pharmacovigilance Department collects and evaluates product safety information from around the world throughout the day and night, from the early stage of drug development through to market launch and beyond. The department conducts risk management of investigational new drugs and Taiho pharmaceutical products marketed in and outside Japan, in cooperation with relevant departments internally as well as affiliated companies including overseas subsidiaries. By ensuring the safety of patients in clinical trials and promoting proper drug use after launch, the department is contributing to the discovery and development of drugs at Taiho.