On September 12, 2024, the Pharmaceutical and Medical Device System Subcommittee (the "Subcommittee") of the Japanese Ministry of Health, Labor and Welfare ("MHLW") convened and established a discussion timeline for the amendment of the Pharmaceuticals and Medical Devices Act ("PMD Act"). The PMD Act is administered by the MHLW and establishes the framework for regulating pharmaceuticals, cosmetics, in-vitro diagnostic reagents, and medical devices in the Japanese market. The timeline features topics that the Subcommittee plans to focus on and discuss specific amendments to the PMD Act for the remainder of 2024, including:
- Access to medicines, such as drug loss and supply shortages – establishment of a safe and rapid approval system;
- Implementation of legal compliance and quality assurance initiatives in response to new pharmaceutical technology;
- Review of the registration and certification system for medical devices; and
- Review of pharmacy and pharmaceutical sales systems' digitalization progress in response to the declining birthrate and aging population.
On October 3, 2024, the Subcommittee reconvened and presented proposals for amendment as well as improvement in current regulatory practice for three of the key themes highlighted above.
1. Drug Loss and Supply Shortage Alleviation
The term "drug loss" has been used in Japan to describe the problem where drugs approved overseas are not available in Japan due to complicated approval processes. The MHLW has been seeking to address problem and encouraging foreign pharmaceutical companies to apply for regulatory and marketing approval in Japan.
During the October 3 meeting, the Subcommittee approached this issue from several angles. Firstly, the development of pediatric medicine has been challenging due to low patient numbers and small market for the pharmaceutical product. To encourage innovation and development of pediatric medicine, the Subcommittee proposed adding a best efforts requirement for a pediatric drug development plan during the clinical development process, as well as further lengthening the reexamination period from 10 years to 12 years.
In addition, the Subcommittee presented several proposals to ensure patient access to drugs with "high medical necessity". Citing the Accelerated Approval process in the U.S. and the Conditional Approval process in the E.U., which are both meant to facilitate the approval process for drugs that fulfill unmet medical needs, the Subcommittee proposed a conditional approval program where drugs may receive conditional approval after demonstration of clinical efficacy in phase II clinical trial, subject to further evaluation of efficacy and safety after the drug enters the market. Since existing requirements for the demonstration of efficacy and safety during clinical trials could be too onerous when the number of clinical trial participants are low, the Subcommittee proposed to amend the PMD Act so that drugs with high medical necessity can be conditionally approved when the effectiveness outweighs the risk of unconfirmed efficacy.
Additionally, to improve access to pharmaceutical products when there is a lack of supply of approved drugs, the Subcommittee called for the establishment of a prompt review and approval process for substitute products that are currently being used in foreign countries. However, the Subcommittee also noted that such foreign product approval should only be temporary and granted when there is a significant medical impact due to a short supply of approved pharmaceutical products.
2. Streamlining the registration and certification process for medical devices
Recognizing the increased demand on in vitro diagnostic products such as testing kits for COVID-19, the Subcommittee emphasized the need for regulations that help ensure the reliability and performance of such products after they have entered the market. One of the Subcommittee's proposals states that for in vitro diagnostic reagents that detect viruses that have a particularly high mutation rate, post-marketing regulations should be established for information collection, evaluation, and reporting by manufacturers and distributors. In addition, the Subcommittee introduced a system similar to the re-evaluation of drugs, where marketing approval can be removed if post-marketing performance cannot be guaranteed.
Another focus of the Subcommittee is the practical application of Software as a Medical Device (SaMD). Recognizing that SaMD can alleviate burdens on medical workers and promote medical care equity, the Subcommittee proposed to continue the trial implementation for the priority examination of SaMD and expand the priority examination process to medical devices with the similar functions as SaMD. Additionally, for SaMD categorized by the PMD Act as a Class II medical device that posts low risks to the human body, the Subcommittee proposed shortening the clinical trial or clinical performance evaluation process when certain requirements are met.
3. Enhance the ability for local pharmacies to meet rising healthcare demand
In addition to the above themes, the Subcommittee also presented proposals to build up the functionalities of local pharmacies and pharmacists to better support the healthcare needs of an aging Japanese population. Local pharmacies that carry out "health support programs" such as nutrition consultation services and promotion of preventative health practices can receive certification from the MHLW as a "health support pharmacy". The Subcommittee also envisions an information sharing network between local hospitals, pharmacies, and clinics so that patients' prescription information can be effectively communicated.
The Subcommittee and MHLW will continue to review themes presented in the September 12 discussion timeline during the remainder of 2024, with the goal of presenting amendments to the PMD Act to the National Diet by early 2025. Medical device and pharmaceutical companies that are interested in marketing their products in Japan are strongly encouraged to follow the remaining Subcommittee meetings and review its proposed amendments to the PMD Act.
The authors want to thank Mr. Miguel Kitamura, the founder of KitamuraLaw, for contributing to this article.
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