Pharmacovigilance

Figure 1. MTID PV Participation in the ASEAN–Japan RMP Symposium

MTID Pharmacovigilance System - A Commitment to Patient Safety

According to the definition by World Health Organization (WHO) and Indonesian FDA (BPOM) Pharmacovigilance (PV) encompasses all activities related to the detection, assessment, understanding, and prevention of adverse reactions or any other medicine-related problems. Pharmacovigilance activities are conducted to ensure patient safety and the appropriate use of medicinal products throughout their lifecycle.

In line with Indonesia’s BPOM Regulation No. 15 of 2022, which requires pharmaceutical companies to ensure the safety of marketed medicines, PT Mitsubishi Tanabe Pharma Indonesia (MTID) has established a PV system to monitor and ensure the safety of its products.

MTID PV system is defined as a system used by a company to fulfil its legal tasks and responsibilities in relation to PV and designed to monitor the safety of authorized medicinal products and detect any change to their risk-benefit balance. The PV system is described by its structure, processes, and outcomes which is realized in a PV quality system. 

As a part of Tanabe Pharma Corporation (TP) Group Companies, MTID formulates quality objectives upon global policy of Drug Safety Management, action guidelines for PV units and the applicable regulatory requirements for PV and drug safety activities in all stages of product life cycle safety management.

The overall quality objectives of a MTID PV system are:

  • Complying with the legal requirements for PV tasks and responsibilities;
  • Preventing the occurrence of adverse reactions/adverse drug reactions arising from the use of authorized MTID products within or outside the terms of marketing authorization or from occupational exposure;
  • Promoting the safe and effective use of MTID products, in particular through providing timely information about the safety of MTID products to patients, healthcare professionals and the public; and
  • Contributing to the protection of patients’ and public health.
Figure 2. Pharmacovigilance team conducted refreshing training

On October 16–17, 2025, MTID had the opportunity to undergo an inspection by BPOM to evaluate the implementation of PV at MTID, demonstrating that our PV system is fully operational. MTID remains committed to conducting PV activities diligently and ensuring full compliance with applicable regulations.

The successful implementation of PV at MTID relies on the active participation of every MTID member. From monitoring and reporting safety data to supporting risk management activities, each team member plays a vital role in maintaining the integrity and effectiveness of MTID PV system. Through close collaboration, we ensure that medicines are used safely and responsibly, and that patient safety remains our top priority in everything we do.

To support this commitment, MTID encourages the reporting of adverse reactions or any other medicine-related problems. If you receive a report regarding MTID product, you could report it to the MTID’s Pharmacovigilance Section through menu Contact Us. At MTID, Patient safety is not a choice, it is an obligation.