TOKYO - The revised Pharmaceuticals and Medical Devices Act, passed by Japan's Upper House on May 14th, will allow over-the-counter drugs to be sold at convenience stores if consumers first receive online guidance from licensed pharmacists or other qualified professionals.
The reform also includes new measures to address the growing social issue of drug overdoses, particularly among young people. To curb misuse, the law will introduce age-related restrictions on the purchase of certain OTC medications.
Japan's regulation of pharmaceuticals dates back to the late 19th century, with the introduction of the "Regulations on Handling and Sales of Medicines" in 1889. This laid the groundwork for systematic control of drug safety and efficacy. In 1943, during the wartime period, the Pharmaceutical Affairs Law (PAL) was enacted to bring a more comprehensive legal framework to drug regulation. This law was overhauled in 1948 and again in 1960 in response to postwar public health needs and international developments. The 1960 version, known as Law No. 145, became the core legal structure for drug and medical device regulation in Japan for decades. It aimed to ensure the quality, efficacy, and safety of pharmaceuticals, cosmetics, and medical devices, and governed their manufacture, sale, labeling, and advertisement.
As medical technology and international regulatory standards advanced, so too did the need for Japan to modernize its pharmaceutical laws. One of the most significant reforms came in 2002, when the PAL was amended to introduce a risk-based classification system for medical devices. This shift aligned Japan’s system more closely with global norms and placed greater emphasis on post-marketing surveillance rather than just pre-approval inspections. The 2002 revision also acknowledged the growing complexity of biotechnology and the necessity of maintaining rigorous safety protocols even after products entered the market.
A decade later, in 2013, another sweeping amendment was made in response to the rapid development of regenerative medicine and biologics. This amendment introduced a new category for regenerative medical products and established a conditional, time-limited approval system that enabled earlier patient access to innovative therapies while still ensuring safety through follow-up monitoring. In recognition of the broader scope of products now covered by the legislation, the law was renamed the Pharmaceuticals and Medical Devices Act (PMD Act). This revision marked a turning point by officially including regenerative medicine under its jurisdiction, facilitating faster innovation cycles and supporting Japan's ambition to become a leader in advanced medical technology.
To support the implementation and oversight of these changes, the Japanese government established the Pharmaceuticals and Medical Devices Agency (PMDA) in 2004. The PMDA became the central body responsible for product review, safety monitoring, and post-market surveillance. It works in collaboration with the Ministry of Health, Labour and Welfare (MHLW) to ensure regulatory compliance and respond to emerging public health risks. Over the years, the PMDA has grown in capacity and international presence, playing a key role in global drug safety initiatives and harmonization efforts with counterparts such as the U.S. FDA and the European Medicines Agency.
The most recent revision in May 2025 focuses on expanding consumer access to over-the-counter (OTC) drugs while strengthening measures against misuse, particularly among young people. With the rise in convenience-focused retail and the increasing social issue of drug overdoses among youth, the government amended the PMD Act to allow sales of OTC drugs in convenience stores, on the condition that buyers first receive online explanations from licensed pharmacists. At the same time, the amendment introduces age-based restrictions on certain products to address concerns over abuse.
Source: Kyodo
