Pharmacovigilance in Japan
How is it with the drug safety system in the “Land of the Rising Sun”? Read our guide to get a clear picture.
And of course, if you feel you need a local consultant, we’re here for you.
Current status of our Japanese pharmacovigilance services:
Local Person for Pharmacovigilance
AVAILABLE
Easily managed through Tepsivo Platform >
Local Literature Screening
AVAILABLE
Automated monitoring with Tepsivo Literature >
Who is the main PV authority in Japan?
RESPONSIBILITY FOR NATIONAL PV SYSTEM
The main authority on pharmacovigilance in Japan is the Pharmaceuticals and Medical Devices Agency (PMDA). The agency is responsible for overseeing the safety of pharmaceuticals and medical devices, including the monitoring and evaluation of adverse drug reactions (ADRs) post-marketing.
While the main authority resides in Tokyo, the PMDA has established regional branches, such as those in Kansai and Hokuriku.
Useful insights about the authority website
LIMITED CONTENT IN ENGLISH
The website offers an English version, and many pages are translated. However, some sections may only be available in Japanese.
If you’re unable to find what you’re looking for, we recommend accessing the website in its original Japanese version and using a translation tool. This approach will significantly increase your chances of locating the information you need.
Interesting website sections related to pharmacovigilance
DRUGS
A signpost that directs you into more concrete subsections regarding drugs, such as safety information, procedures regulations and more. Some of the subsections are also mentioned below.
FREQUENTLY ASKED QUESTIONS
This Q&A section is pretty useful, usually it just contains some general information, but here it includes some important link (such as Application for Product Approval or Accreditation of Foreign Manufacturers, …), so definitely recommended to visit this section.
DRUG REVIEW
General information about the process of reviewing the drugs, including intel on Master File System, Accreditation of Foreign Manufacturers or Regulatory information on the reviewed drugs (inconspicuous link at the end of the section about the drugs). For enter these mentioned subsection visit the panel on the right site on the linked page.
SCIENTIFIC PUBLICATIONS
All of these publications are sorted by years into individual categories, the vast majority is in English, but there is also a section with Japanese articles, studies etc.
FORMS TO DOWNLOAD
All forms in one place, all can be downloaded, sorted into individual categories, relatively easy to navigate there, when you choose the section thath you’re interested in, there usually appears a table with the form(s) you’re looking for.
APPROVED PRODUCTS
On this page you’ll find PDF tables containing the all the approved drugs within a certain period.
APPLICATION PROCEDURES
This section contains general information on applications, including some of the important forms, intel on fees, how to submit online etc.
Other important institutions & industry groups
MINISTRY OF HEALTH, LABOUR AND WELFARE (MHLW)
Central government ministry responsible for health policy in Japan. It oversees various bureaus and agencies that deal with specific aspects of healthcare, including: Health Policy Bureau, Health Service Bureau, Pharmaceutical and Medical Safety Bureau, etc.
In the section “White Paper & Reports”, you can find Annual Health, Labour and Welfare Report (last one is from 2022), which accessible also in English, though it is stated that the transaltion is unofficial due to the machine translation. There is also section called “Vital statistics”, where are summaries, that include numbers on Population, Live births, Deaths, Infant deaths and more, if you’d like more statistics, visit e-Stat.
Ministry’s website: https://www.mhlw.go.jp/english/
NATIONAL INSTITUTE OF PUBLIC HEALTH (NIPH)
The NIPH is a government research and training organization charged with improving public health in Japan. It conducts education, training, surveys and research to enhance health, healthcare and welfare in Japan.
On their website you can find a material (only in Japanese), which is an annual record of research achievements, including original texts, books, review articles etc. They also have their own journal called “Hoken Iryo Kagaku”, though once again it’s only in Japan.
NIPH’s website: https://www.niph.go.jp/en/information-en/
JAPAN PHARMACEUTICAL MANUFACTURERS ASSOCIATION (JPMA)
The JPMA is a major trade association representing the research-based pharmaceutical industry in Japan. It focuses on promoting the interests of its member companies, enhancing the pharmaceutical environment, and advocating for policies that support innovation and drug development.
Though the website does offer English version, we recommend to use the original one in Japanese, since it has more interesting content. From which we can mention the section “What’s new”, where important information regarding the industry are published. Then there is also Medication Guide for the General Public, where for example are nicely described different types of medicine or the process of drug development.
JPMA’s website: https://www.jpma.or.jp/english/index.html
JAPAN BIOINDUSTRY ASSOCIATION (JBA)
The JBA represents the biotechnology sector in Japan, including companies involved in biopharmaceuticals, agricultural biotechnology, and related fields.
Both versions of the website Japanese and English do not offer much interesting content. JBA publishes their own bimonthly journal “Bioscience and Industry (B&I)”, but as it seems it is not for free. The there is a section called “Bioventure Database”, which includes companies, that take part in the industry, you can see their list there along with main products & services and other additional information.
JBA’s website: https://www.jba.or.jp/
Some of the most important laws
Basic legislation
Assigns responsibilities for pharmacovigilance to marketing authorization holders, healthcare professionals, and citizens.
Guidelines
Good Vigilance Practice (GVP) Ordinance
The most important ordinance governing pharmacovigilance in Japan. It requires marketing authorization holders to have a safety management department, appoint qualified personnel, and establish standard operating procedures for pharmacovigilance activities.
Guidelines section on PMDA’s website
Here you can find some more guidelines on various topic sorted by area/field.
Local pharmacovigilance specifics
Useful abbreviations to know
If you want to study local materials about pharmacovigilance in Japan, following terms will be helpful for you to get familiar with:
PMD act: Pharmaceuticals and Medical Devices Act
→ key legislative on health policy
DMF (Drug Master File)
→ submit the detailed information of APIs to the Review Authority / in Japan the DMF is sometimes called just “Master File” or “MF”
PMDA (Pharmaceuticals and Medical Devices Agency)
→ main authority on pharmacovigilance
MHLW: Ministry of Health Labor and Welfare
→ government ministry responsible for health polic
Is Qualified Person Responsible for Pharmacovigilance needed?
In Japan, it is seems that it is not mandatory to have a local person specifically designated for pharmacovigilance activities, since it seems to be no mention of QPPV anywhere on the PMDA website, nor it seems that there is any other name for the role.
Here is a link for Outline of Post-marketing Safety Measures to get a bit clearer picture in this area.
How can be adverse events reported in Japan?
PMDA accepts reports of ADR from patients, medical professionals and companies. Each of these groups has a description of how to proceed with ADR reporting, sadly on in Japan.
The process of reporting varies, for example medical professionals seem to have online reporting, but companies do not.
Local medical journals to screen
Here are few examples of Japanese local literature that medical authorization holders should monitor:
JMA JOURNAL
Official journal of the Japan Medical Association, focusing on a wide range of medical topics, including clinical practice and health policy.
It aims to contribute to global medical standards through high-quality research and is an open-access platform for both Japanese and international authors.
ISSN: 2433-3298
JOURNAL OF THE JAPANESE SOCIETY OF INTERNAL MEDICINE
This journal publishes research focused on internal medicine, providing insights into clinical practices, case studies, and new treatment methodologies.
It serves as a vital resource for healthcare professionals seeking to stay updated on advancements in internal medicine.
ISSN: 1883-2083
JOURNAL OF JAPANESE ASSOCIATION FOR ACUTE MEDICINE
It focuses on acute care medicine, including emergency medicine and critical care.
This journal offers valuable research findings and clinical guidelines that help improve patient outcomes in urgent medical situations.
ISSN: 1883-3772
JAPANESE JOURNAL OF CLINICAL ONCOLOGY
This journal specializes in oncology, publishing original research, reviews, and clinical trials related to cancer treatment and prevention.
It is essential for oncologists and researchers looking for the latest developments in cancer therapies and patient care strategies.
ISSN: 1465-3621
Rather then spending your budget for hours of repetitive manual work to monitor those sources, we recommend to simply automate this task using our Tepsivo Literature solution.
Other interesting resources
Scientific publications regarding pharmacovigilance
This article shines a light on the growing recognition of pharmacovigilance in Japan, revealing surprising gaps in hospital pharmacists’ knowledge and attitudes toward reporting adverse drug reactions (ADRs).
Dive into the serious issue of drug-induced acute kidney injury (AKI), revealing insights from a comprehensive analysis of over 534,000 reports in Japan. Readers can expect to discover how different anti-infective medications impact kidney health.
Pharmacovigilance for Herbal and Traditional Medicines in Japan
This article explores the world of herbal products in Japan, including traditional Kampo medicines and non-Kampo alternatives, while shedding light on the safety concerns that have emerged over the years.
This study uncovers the surprising links between various medications and the risk of developing glaucoma, a condition that often goes unnoticed until it’s too late. By analyzing data from Japan’s national adverse drug event database, the researchers highlight specific drugs—especially steroids and certain antidepressants—that can trigger this serious eye condition, offering crucial insights for both healthcare providers and patients.
interesting resources
Centralized platform that provides information on Japanese health policy in both Japanese and English, you can find there information regarding medical insurance, healthcare system or drugs overall.
This page contains basic staticsits about Japan in various fields such as Population, Life expectancy or Health statistics.
Official statistics of Japan at glance, fully translated in English. Here is a link for graphs on the most importnant areas.
Do you need some help with putting the Japanese PV System together? We’re here for you.
And while you’re here…
…consider also our global end-to-end PV solution!
Thanks to the Tepsivo platform, you can get a full pharmacovigilance system in all countries you need – for a fraction of the usual budget.
Tepsivo Oy | Urho Kekkosen katu, 4-6 E, 00 100, Helsinki, Finland | VAT number FI31367614 | contact@tepsivo.com | +358 402 204 698 | Privacy policy
