Introduction to Japan’s Regulatory Budget Proposal
According to the news (PMDA審査官増員、手数料にも補助 医薬局・25年度概算要求 | 日刊薬業 – 医薬品産業の総合情報サイト (jiho.jp)) released by NIKKAN YAKUGYO on Aug/28/2024, in the latest budget proposal for fiscal year 2025, the Pharmaceutical and Food Safety Bureau of Japan’s Ministry of Health, Labour and Welfare (MHLW) has requested ¥11.2 billion, an increase of ¥1.9 billion compared to the previous year. A key focus of this budget is addressing the drug lag and loss issues in Japan by supporting pharmaceutical companies through consultation fee subsidies and increasing the number of reviewers at the Pharmaceuticals and Medical Devices Agency (PMDA).
Enhanced Support for Unapproved and Orphan Drugs
One of the major initiatives within this budget includes ¥141 million to support a program to evaluate and promote the development of unapproved and off-label drugs without waiting for requests from medical societies. In line with this, seven new reviewers will be hired at PMDA to accelerate the evaluation of orphan drugs, partially funded by government subsidies.
Consultation Fee Waivers and Subsidies for Drug Development
The government plans to waive consultation fees for pediatric drug development to encourage more pharmaceutical companies to participate, particularly those developing pediatric and orphan drugs. Additionally, consultation fees will be subsidized by 50% for drugs related to the unapproved drug review system, orphan drugs, and investigator-initiated clinical trials. This effort aims to incentivize more companies to participate in developing critical therapies.
Expansion of PMDA’s International Presence
To facilitate drug development and regulatory submissions by overseas companies, including startups, Japan plans to expand PMDA’s US office by adding one more staff member. The budget for this expansion is set at ¥98 million, which will enhance PMDA’s ability to engage with foreign biotech companies and promote regulatory submissions in Japan.
This budget proposal underscores Japan’s commitment to reducing the drug lag and supporting the development of orphan drugs while enhancing international collaboration. For business development and regulatory professionals working outside Japan, these measures signal new opportunities for drug development and market entry in Japan.