- Enhancement of quality and safety assurance
The Ministry of Health, Labour and Welfare (MHLW) has recently become aware of cases in which the leadership of companies (particularly the Responsible Officers of Marketing Authorization Holders) failed to respond to violations of the PMD Act despite awareness of them. In some cases, the Responsible Officers were even primarily responsible for the violations. Prior to the 2025 Amendment, the PMD Act only set out the duties of key managers (e.g., General Marketing Compliance Officers) and did not have strict rules regarding unlawful behavior by these individuals. The 2025 Amendment introduces rules under which the MHLW may order a company to change its Responsible Officer to prevent or reduce a risk to human health in the event that the Responsible Officer has caused a violation of the PMD Act. These rules are expected to enter into effect within two years of the promulgation of the 2025 Amendment (i.e., no later than 14 May 2027).
Further, the 2025 Amendment moves a Marketing Authorization Holder's obligation to appoint a Quality Manager and Safety Manager from ministerial ordinances (i.e., the GQP Ordinance and the GVP Ordinance) to the PMD Act itself. This change is intended to clarify the roles and responsibilities of these key managers and enhance company control over quality and safety assurance. It is expected to enter into effect within two years of the promulgation of the 2025 Amendment (i.e., no later than 14 May 2027).
To address concerns about the risk to public health posed by a pharmaceutical company’s failure to quickly collect and analyze information and take action, the 2025 Amendment introduces rules requiring a Marketing Authorization Holder to establish an adverse event information collection plan with respect to pharmaceutical products specified by the MHLW and implement the plan.
- Reinforcement of ethical drug, etc. supply system stability
Prior to the 2025 Amendment, the PMD Act lacked clear provisions on the management of supply systems. In response to incidents of manufacturing misconduct and prolonged pharmaceutical shortages, the 2025 Amendment introduces a system to support pharmaceutical supply stability.
First, the 2025 Amendment requires the appointment of a "Supply System Manager" (kyokyu kanri sekininsha) to introduce and oversee a system to ensure supply stability. Pharmaceutical companies are also now required to notify the Minister of Health, Labor and Welfare of shipment suspensions and supply adjustments. In the event of a supply shortage, the Minister of Health, Labor and Welfare may request that manufacturers and distributors cooperate to increase production, adjust sales or secure alternative products.
In addition, a new marketing authorization change category has been introduced. Formerly, marketing authorization holders were required only to notify the Minister of Health, Labour and Welfare of minor changes to their marketing authorizations. However, the approval of the Minister of Health, Labour and Welfare was required for more significant changes — including changes to manufacturing methods, etc. — and the approval process was time-consuming. Under the 2025 Amendment, changes that are not expected to significantly impact quality and are considered to pose moderate risk can be approved through a simple and expeditious procedure expected to take approximately 40 days. Further, companies can now report minor changes in manufacturing methods, etc. that are expected to have little impact on quality to the Minister of Health, Labour and Welfare on an annual basis. These measures are expected to improve procedural efficiency and thereby contribute to pharmaceutical supply stability.
The 2025 Amendment includes another measure to address supply shortages of approved drugs, etc. that would significantly impact medical care. In such cases, the 2025 Amendment allows special exceptions for substitutes distributed in foreign countries (e.g., priority approval review, etc.) and allows such substitutes to be distributed with foreign-language labeling for a certain period of time. Lastly, a new national fund has been established to support the quality and stable supply of generic drugs.
All of these changes to the marketing authorization system are expected to enter into effect no later than three years from the date of the 2025 Amendment's promulgation (i.e., no later than 14 May 2028).
- Improvement of pharmaceutical research and development
In the past, the Japanese drug approval process has lagged behind those of other countries, and development of therapeutic drugs for rare diseases and pediatric diseases has stagnated. The conditional approval system has therefore been revised under the 2025 Amendment to expedite commercialization of innovative drugs.
The existing conditional approval system was considered ineffective due to its limited applicability and the low number of approvals granted under it. The 2025 Amendment redesigns the system to allow conditional approval of drugs, medical devices and in vitro diagnostic products whose clinical efficacy in the treatment of serious diseases for which no appropriate alternative treatment exists can be reasonably predicted at the exploratory study stage.
In addition, to address stagnation in pediatric drug development, the 2025 Amendment requires marketing authorization holders to make efforts to formulate development plans for pediatric drugs. The 2025 Amendment also establishes a fund to support research and development of innovative new drugs and expedite their introduction. These measures are expected to strengthen Japan's pharmaceutical research and development capabilities and give patients treatment options without delay.
The revisions to the conditional approval system and the pediatric drug development system are expected to enter into effect within one year of the date of the promulgation of the 2025 Amendment (i.e., no later than 14 May 2026).
- Strengthening pharmacy functions
Japan's aging population is increasing demands for medical care. The 2025 Amendment includes changes intended to improve the efficiency of pharmacy operations and promote proper use of pharmaceuticals.
Specifically, the 2025 Amendment allows some dispensing operations to be outsourced and remote sales of OTC drugs are permitted even at pharmacies without full-time pharmacists. In addition, sales methods have been reviewed for drugs that have the potential for abuse and ceilings have been set on the quantities sold to young people in order to ensure proper use of these drugs.
These changes are expected to enter into effect within two years of the promulgation of the 2025 Amendment (i.e., no later than 14 May 2027).
Key takeaways
As mentioned above, this amendment was passed on 14 May 2025 and the new systems will come into effect in phases. Pharmaceutical companies and related businesses will need to take action in accordance with the enforcement date of each system while closely monitoring relevant notices and guidelines that may be issued by the MHLW.
