In May 2025, the "Act to Partially Amend the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (hereinafter referred to as the "PMD Act") was promulgated.

Along with measures to address "drug loss" and ensure a stable supply of pharmaceuticals, this amendment includes a review of regulations for "In-Vitro Diagnostics (IVD)" based on lessons learned from the COVID-19 pandemic. Changes that will significantly impact IVD business practices are planned.

Furthermore, from the perspective of clarifying the scope of test kits that fall under the regulatory net of the PMD Act for IVDs, a draft guideline regarding the scope of IVDs for test kits, etc., labeled as "for research use" recently underwent a public comment period, which has now concluded."

This article explains two topics that have a significant impact on practice: (1) an overview of the new draft guideline concerning the determination of classification for test kits labeled as "for research use," and (2) specific amendment items for IVDs in the amended PMD Act.

Overview of the Draft Guideline Concerning the Scope of "Research-Use" Test Kits, etc.

During the spread of COVID-19, a major issue that arose was that simple test kits not approved under the PMD Act were widely distributed in drugstores and on the internet under the label of "for research use," and were being used by consumers for self-diagnosis purposes. In response, the Ministry of Health, Labour and Welfare (MHLW) compiled the "Guidelines on the Scope of IVDs for Test Kits, etc. Labeled for Research Use (Draft)" and announced a policy to clarify the criteria for determining such classification.

(1) Shift from "Labeling" to "Actual Status" Judgment

Whether a product is classified as a pharmaceutical or medical device is defined by the "purpose" of the product. The determination of the existence of such a purpose should be made based on both the objective performance and usage of the product (actual status) and how the effects and usage of the product are presented in advertisements, etc. (labeling/presentation). However, until now, the classification of IVDs tended to place weight on whether "diagnostic purposes" were claimed (labeled) on the product, and there was an aspect where products were unlikely to be subject to regulation immediately if they were labeled "for research use." However, this draft guideline clarifies that determination will be made based on the objective actual status—"whether a general person can easily recognize it as an In-Vitro Diagnostic (something used for diagnosis)"—rather than simply whether it is labeled "for research use."

(2) Comprehensive Factors for Determination
 
Specifically, the determination will be made by comprehensively considering the following elements:

• Shape: Whether the kit format (such as swabs or cassettes) allows a general person without specialized knowledge to complete the process from specimen collection to result determination.
• Sales Method: Whether it is sold through channels easily accessible to the public, such as drugstores or e-commerce sites for general consumers.
• Labeling/Advertising: Whether expressions suggesting diagnostic results, such as "detects infection" or "see a doctor if positive," are used, or if quality is implied through the display of international certifications (FDA, etc.).

If a product is deemed to be provided for diagnostic purposes in practice based on these factors, it will be considered an "unapproved/unlicensed pharmaceutical" in violation of the PMD Act, even if it is labeled "for research use," and will be subject to administrative sanctions and criminal penalties.

(3) Future Schedule
 
This draft guideline is scheduled to be subject to public comment starting in January 2026, with a notice expected to be issued in early March of the same year. After the notice is issued, strict implementation is anticipated, making it urgent for related businesses to review their product sales channels and labeling.

Evolution of In-Vitro Diagnostics (IVD) Regulations under the Amended PMD Act

Under the amended PMD Act, which will be implemented in stages starting May 1, 2026, regulations are being streamlined and strengthened based on the characteristics of IVDs, such as "not being used directly on the human body" and "targets (viruses, etc.) undergoing mutations." The following four points are the main changes:

(1)    Post-Marketing Performance Maintenance and Revocation of Approval (Related to Articles 23-2-10-2 and 74-2)
 
Based on instances where existing test kits failed to react to mutant strains of COVID-19, marketing authorization holders are now newly obligated to confirm and evaluate whether performance is maintained in response to viral mutations, even after being placed on the market, and to report this to the government (Re-evaluation of Performance, etc.).

Furthermore, a mechanism has been introduced to revoke approval if post-marketing performance cannot be guaranteed, such as the inability to detect mutant strains because of the evaluation. This is a powerful measure like the re-evaluation system for pharmaceuticals, and companies are required to ensure quality throughout the entire product lifecycle.

(2) Establishment of Reliability Standards for Clinical Performance Studies (IVD version of GCP) (Related to Article 23-2-5) 

Until now, there were no clear legal standards, such as GCP (Good Clinical Practice) for pharmaceuticals, for "clinical performance studies (tests using specimens)" used in approval applications for IVDs. The amended Act includes a legal requirement that performance studies using clinical specimens must be collected and created in accordance with standards for ensuring data reliability (conforming to GCP) as a condition for approval. This necessitates more rigorous handling of contracts with medical institutions conducting the studies and in data management.

(3) Shift from "Adverse Reaction Reporting" to "Malfunction Reporting" (Related to Article 68-10) 

Since IVDs are legally classified as "pharmaceuticals," under the PMD Act in Japan, they were previously subject to "Adverse Reaction Reporting." However, the concept of "adverse reactions" (side effects) is not suitable for IVDs, which are not administered directly to the human body, and this was not aligned with international practice. With this amendment (and related ministerial ordinance amendments), the framework will shift to "Malfunction Reporting," like regulations in the U.S. and Europe and those for medical devices. As a result, performance deficiencies that cause incorrect diagnostic results (false positives/false negatives) will be reported under the appropriate category.

(4) Relaxation of Requirements for Manufacturing Managers (Related to Article 23-2-14)

The person in charge of an IVD manufacturing site (Manufacturing Manager) was required, in principle, to be a pharmacist. However, since the number of products that do not necessarily depend solely on the professional skills of a pharmacist is increasing due to advancements in biotechnology, a special exception has been established. In cases where securing a pharmacist is significantly difficult, "engineers who have completed specialized courses (biology, chemistry, etc.) at a university or similar institution" may also be recognized as Manufacturing Managers.

 

Impact on Practice and Required Actions

The current institutional reforms simultaneously demand stricter control at the entry point (classification determination) and higher sophistication in content (approval review and post-marketing management) for the In-Vitro Diagnostics (IVD) business. Companies are recommended to urgently verify the following points in particular:

1. Comprehensive Review of "Research-Use" Products: Confirm whether research reagents handled by your company are flowing into sales channels for general consumers and whether advertising expressions imply diagnosis and take corrective actions as necessary before the guideline notice is issued.

2. Establishment of Post-Marketing Performance Evaluation Systems: Develop internal processes to quickly perform tasks ranging from collecting mutation information to internal performance verification (wet tests, etc.) and reporting to the authorities (MHLW/PMDA). 

3. Review of GVP/GCP Standard Operating Procedures: Prepare for the revision of relevant Standard Operating Procedures (SOPs) in conjunction with the transition to malfunction reporting and the introduction of new GCP standards.

Our firm provides advice on regulatory compliance in the healthcare and life sciences fields based on the latest legislative amendments. If you have any questions, please feel free to contact us.

Note: This article is based on information as of the time of its writing (February 2025), and details may change depending on the status of the enactment of cabinet orders and ministerial ordinances related to enforcement.