ANNOUNCEMENT
PILOT PROJECT FOR CTIL/CTX RELIANCE PATHWAY BETWEEN NATIONAL PHARMACEUTICAL REGULATORY AGENCY (NPRA), MALAYSIA AND PHARMACEUTICALS AND MEDICAL DEVICES AGENCY (PMDA), JAPAN
Following successful bilateral discussions initiated on 1st August 2025 and finalized on 28 January 2026, the National Pharmaceutical Regulatory Agency (NPRA) is pleased to announce the launch of a 6-month Pilot Project for the Clinical Trial Reliance Pathway in collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.
This pilot project aims to enhance regulatory efficiency, accelerate access to quality, safe, and effective investigational products, and optimize resources by leveraging the regulatory assessments conducted by PMDA. This pathway maintains strict NPRA regulatory oversight and public health protection while streamlining the approval process.
1. SCOPE AND TIMELINE OF THE PILOT PROJECT
- Duration: 6 months (Target: October 2026 - March 2027)
- Target Participation: 5 clinical trial protocols or more
- Product Scope: At least 3 different product/study types (e.g., Biologics, New Chemical Entities [NCE], Generic Drugs, Herbal Products, First-in-Human [FIH] trials)
- Eligibility Criterion: The clinical trial application must have completed the standard 30-day assessment process by PMDA, Japan.
2. REQUIRED DOCUMENTATION AND FORMS
Applicants participating in this pilot project must prepare and ensure the availability of the following documents:
i. A Letter of Intent (LOI) / cover letter to use reliance for the application.
ii. NPRA CTIL/CTX Application Form (N2-FR-07/3, N2-FR-08/3) & full documents as submitted for screening of standard CTIL application.
iv. Regulatory Reliance Review (RRR) Consent Form : Authorising the reliance mechanism.
3. SUBMISSION STEPS & BILATERAL PROCESS
The application follows a structured bilateral workflow between the applicant, NPRA, and PMDA:
i. Eligibility Check: The applicant/sponsor ensures that the specific clinical trial has successfully completed PMDA's 30-day evaluation.
ii. NPRA Initiation & Request: NPRA will submit a formal application request to PMDA. For this to occur, the applicant must provide NPRA with the documents stated above.
iii. Evaluation & Approval: NPRA will review the application based on PMDA's assessment inputs.
4. IMPLEMENTATION OUTCOMES
The data and outcomes gathered during this 6-month pilot will be analysed to establish permanent regulatory guidelines for future Clinical Trial Import License (CTIL) / Clinical Trial Exemption (CTX) applications and product registrations utilising the NPRA-PMDA reliance framework.
5. FREQUENTLY ASKED QUESTIONS (FAQ)
Q1: What happens if an application is submitted before PMDA completes its 30-day review?
A: The application will not qualify for the reliance pathway. The applicant may proceed via the standard CTIL/CTX pathway or wait until PMDA completes its evaluation.
Q2: Does NPRA accept applications with the same IP but a different protocol from the one that completed PMDA's 30-day review?
A: No. Applicants must ensure that it is the same protocol that has completed PMDA's 30-day review.
Q3: What is the expected timeline of completion compared to the standard review?
A: We aim to reduce the timeline of standard review by half, and we are in the midst of collecting data to determine the ideal timeline for this reliance pathway.