Partnering for Success in Japan Pharmacovigilance
If you are a pharmaceutical manufacturer, healthcare provider, or life sciences organization operating in Japan, explore DDReg’s pharmacovigilance and drug safety services in Japan to ensure drug safety and regulatory compliance. From adverse drug reaction reporting to compliance with PMDA pharmacovigilance guidelines, the right PV partner shapes everything including signal detection, risk management planning, safety reporting, and successful market authorization.
Expert Pharmacovigilance Services for the Japan Market
The Pharmaceuticals and Medical Devices Agency (PMDA), in collaboration with the Ministry of Health, Labour and Welfare (MHLW), oversees post-marketing surveillance of medicinal products and medical devices in Japan. This includes implementing a unique three-pillar safety system encompassing safety review of medicinal products, post-marketing safety measures, and relief services for adverse health effects. Reporting of adverse events in Japan is voluntary and can be reported by healthcare professionals via email, fax, and post; the general public can report through the website; and marketing authorization holders (MAH) can report via electronic transmission, post, or over the counter. All this safety information, including adverse drug reactions and infections caused by medicines or medical devices, is collected and stored in the adverse drug reaction database (ADR-DB). Further, scientific analysis of this data is conducted to investigate the causal relationship, and the report of this investigation is then submitted to the MHLW to take further actions to safeguard the use of pharmaceuticals and medical devices. Recently, Japan has been implementing new techniques such as data mining methods and sentinel institution networks for accurate and quick responses to problems to prevent as well as predict safety concerns. Additionally, information on the proper usage of medicines and medical devices is available on the website for patient use.
Why Choose DDReg for Pharmacovigilance Services in Japan?
As a leading global contender, DDReg understands the significance of patient safety from clinical trials to post-marketing surveillance of medicinal products. As part of our safety services portfolio, we provide end-to-end pharmacovigilance services in Japan that include adverse drug reaction reporting, signal detection & management, aggregate report writing, and the development of customized pharmacovigilance plans/risk management plans in accordance with local requirements and good pharmacovigilance practices.
Our pharmacovigilance consulting services in Japan ensure compliance with PMDA pharmacovigilance guidelines, facilitating timely and accurate safety reporting and risk management. We offer comprehensive support throughout the product lifecycle, from clinical trials to post-marketing surveillance, ensuring the safety and efficacy of medicinal products in the Japanese market.
Our Pharmacovigilance Services in Japan Include:
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ICSR Processing & Submission
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Risk Management Plan (RMP)
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Aggregate Reports
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Signal Management
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Local Pharmacovigilance Services in South Africa
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