Japan’s PMDA and Malaysia’s NPRA have launched a six-month clinical trial regulatory reliance pilot, with eligible clinical trials expected to shorten the CTIL/CTX review time in Malaysia.
For pharmaceutical companies planning multi-regional clinical trials (MRCT) in Asia, new regulatory collaboration between Japan and Southeast Asian markets is emerging as a new point of connection.
On September 21, 2026, the Malaysian National Medicines Regulatory Agency (NPRA) officially announced the launch of a six-month pilot project for the Clinical Trial Reliance Pathway in collaboration with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
The pilot is planned to be implemented from October 2026 to March 2027, aiming to improve the efficiency of clinical trial application review by referencing the regulatory evaluation results already completed by the PMDA, while maintaining NPRA’s regulatory responsibilities and public health oversight.
What is “regulatory dependence”?
Regulatory Reliance is not simply “endorsing” the approval results of another country.
The core idea is that regulatory agencies, while bearing their own ultimate regulatory responsibilities, should appropriately utilize scientific evaluations already conducted by other trusted regulatory bodies, thereby reducing redundant reviews and improving the efficiency of regulatory resource utilization
This mechanism is especially noteworthy for multinational clinical trials.
Under the traditional model, after the same clinical trial is submitted in different countries, regulatory agencies may need to review a large amount of similar clinical, non-clinical, and quality-related documentation. If regulators can refer to assessments already completed by other established regulatory bodies under certain conditions, it may be possible to reduce duplicate work and shorten overall development time.
This pilot between NPRA and PMDA is being launched against this backdrop.
How exactly will the pilot be implemented?
According to information released by NPRA, this pilot has a clear scope of application.
- Pilot period: 6 months
The project is expected to include:
Running from October 2026 to March 2027.
NPRA plans to include at least five clinical trial protocols, covering at least three different products or types of studies, such as:
- 生物制品（Biologics）
- New Chemical Entity (NCE)
- 仿制药（Generic Drugs）
- 草药产品（Herbal Products）
- First Human Trial (FIH)
- The most critical qualification requirement: PMDA has completed a 30-day review
The most noteworthy aspect of this pilot is the clear requirements for PMDA review status.
Clinical trial applications wishing to use this dependent pathway must have completed the PMDA’s standard 30-day review process.
In other words, applying for the Malaysian regulatory dependency pathway cannot be initiated before the PMDA review. If the PMDA has not completed the 30-day assessment at the time of application, it does not meet the eligibility requirements for this pilot.
In addition, the NPRA specifically states:
It must be the same clinical trial protocol
If the same investigational product (IP) is used but submitted to NPRA for a different clinical trial protocol, this dependency pathway cannot be applied.
NPRA aims to halve the review time
According to information currently released by NPRA, one of the pilot’s goals is to reduce the standard review time by about half. However, NPRA also emphasizes that it is still in the data collection stage, and the final ideal review time will be further determined based on pilot results. Therefore, rather than understanding it as an already fixed “fast-track approval channel,” a more accurate statement is:
This is a validatory pilot targeting regulatory dependence mechanisms for clinical trials.
NPRA will assess whether the mechanism can form a long-term regulatory path based on actual application data from the next six months.
What does this mean for multi-regional clinical trials in Asia?
This change is especially noteworthy for companies planning multi-regional clinical trials in Asia. In the past, when conducting clinical development in Asia, companies typically had to consider regulatory requirements, clinical trial application processes, and timelines for different markets such as Japan, South Korea, China, and Southeast Asia. This NPRA–PMDA pilot at least sends a noteworthy signal:
Asian regulatory agencies are exploring more systematic regulatory collaboration and mechanisms for assessing dependencies.
If this mechanism is implemented long-term in the future and further expanded to other product types or regulatory areas, companies conducting clinical development in Asia may have the opportunity to reduce redundant work through more rational regional filing sequences and regulatory strategies.
For example, for projects planning to enter both the Japanese and Malaysian markets, companies can consider the following during the early development phase:
- Clinical development sequence between Japan and Malaysia
- Alignment between PMDA review nodes and Malaysian CTIL/CTX application deadlines
- Consistency of clinical trial protocols across different markets
- Whether the qualification requirements for regulatory dependency mechanisms are met
- How to coordinate regional clinical trial application materials
This means regulatory strategies increasingly require comprehensive planning early in clinical development, rather than waiting for each market to be filed separately
Japan: Not only a single market, but also a key regulatory node for clinical development in Asia
This collaboration also has an angle worth noting for Chinese and other Asian pharmaceutical companies.
Japan has long been an important market for innovative drugs in Asia and a key member of the ICH system. As multi-regional clinical trials in Asia continue to increase, Japanese regulatory requirements and coordination with other Asian markets are receiving increasing attention.
For Chinese and other Asian innovative drug companies planning to enter the Japanese market, Japanese clinical development should not be seen merely as a standalone market filing issue. At the early stages of the project, considerations include:
How Japan’s clinical development strategy aligns with development plans across the entire Asian region.
The launch of the regulatory dependency pilot by NPRA and PMDA reflects this trend of regional collaboration.
Of course, the project is still in a six-month pilot phase. Whether a long-term mechanism will be established, how much review time will ultimately be saved, and whether it will expand to more countries and product types in the future remains to be seen.
What insights can companies planning to enter the Japanese and Asian markets take?
From the perspective of corporate clinical development, this regulatory development brings at least three noteworthy insights:
First, regional regulatory strategies need to be planned earlier.
If a company plans to conduct clinical development in multiple markets in Japan and Southeast Asia, coordination between clinical trial protocols and submission timelines in each country should be completed as early as possible.
Second, the value of MRCT is extending further from “multinational synchronous development” to regulatory collaboration.
As different regulatory agencies explore mechanisms like reliance and work-sharing, how companies design clinical trials and arrange regional submission sequences may directly impact overall development efficiency.
Third, the Japanese market entry strategy can be further integrated with the Asian clinical development strategy.
For innovative drug companies already planning to enter Japan, Japanese clinical development does not necessarily need to be planned in isolation. Japan’s regulatory pathways, clinical trial nodes, and regulatory collaborations with other Asian markets can all be incorporated into the overall regional development strategy.
CMIC’s perspective
The Asian innovative drug market is becoming increasingly interconnected.
From the clinical trial regulatory dependency pilot initiated by Japan’s PMDA and Malaysia’s NPRA, to the ongoing development of multi-regional clinical trials (MRCT) in Asia, collaboration among regulatory agencies is becoming a key factor affecting regional clinical development efficiency.
For innovative drug companies planning to enter the Japanese and Asian markets, market access planning should not begin with market registration but rather with the clinical development phase.
Coordinating clinical development, regulatory pathways, and submission schedules in Japan and other Asian markets early in the project helps companies better leverage the potential efficiencies brought by regional regulatory collaboration.
CMIC continues to monitor changes in clinical development and regulatory environments in Japan and the Asia-Pacific region, and supports innovative drug companies in developing clinical development strategies that connect the Japanese and Asian markets.
