1. INTRODUCTION

The new route is introduced as part of an initiative by the National Pharmaceutical Regulatory Agency (NPRA) to expand the scope of its facilitated registration pathway, in addition to the existing verification and abbreviated routes. This initiative aims to strengthen regulatory efficiency, enable faster access to quality, safe, and effective products, and leverage prior approvals granted by trusted reference authorities, while maintaining NPRA’s regulatory oversight and public health safeguards.

As an initial step, NPRA is conducting a pilot study focusing on pharmaceutical products (including new drug products, biologics, and generics) approved by the United States Food and Drug Administration (US FDA) and the European Medicines Agency (EMA) through the centralised procedure, as well as the decentralised procedure (limited to generic products only). The pilot will allow NPRA to test and refine the recognition procedure before extending the pathway to products approved by other reference agencies.

 

2. OBJECTIVES

The objectives of this pilot study are to:

• evaluate the proposed procedure and eligibility criteria for the new route under the Facilitated Registration Pathway (FRP) prior to its formal incorporation into the next revision of the FRP guideline;
• support the National Pharmaceutical Regulatory Agency (NPRA) in operationalising the new route within the FRP framework, with eligibility criteria distinct from those of the existing routes;
• facilitate faster access to eligible products by leveraging prior regulatory approvals and scientific assessments from reference agencies;
• reduce duplication of full regulatory review while maintaining NPRA’s oversight and final decision-making authority.

 

3. ELIGIBILITY CRITERIA

An application may be considered under the new route, provided that all of the following criteria are met:

3.1     The product has obtained marketing authorisation from the United States Food and Drug Administration (US FDA) or the European Medicines Agency (EMA) through the centralised procedure, or through the decentralised procedure (limited to generic products only).

Note:

The classification of certain products by the US FDA, EMA or other regulatory agencies may differ from that of NPRA. Applicants are required to submit applications according to the applicable product category in Malaysia.

A tentative approval granted by the US FDA due to existing patent or exclusivity protections may also be taken into consideration, where relevant.

Applicants are advised to submit a classification application if there is any uncertainty regarding the classification.

3.2     The application must be submitted to NPRA via the QUEST system within three (3) months from the date of approval by the chosen reference agency. The three (3)-month validity period shall be calculated from the date of the first complete submission of the dossier to NPRA. Any incomplete dossier shall not be accepted for screening and shall not constitute a valid submission date for the purpose of this requirement.

3.3     The product submitted to NPRA is identical to the product approved by the chosen reference agency, including but not limited to the following:

a)   active ingredient(s);

b)   strength(s);

c)   dosage form;

d)   route of administration;

e)   indication(s) and posology*;

f)   formulation composition; and

g)   container closure system**.

* The proposed indication should be based on broadly comparable population demographics, disease profiles, and expected public health outcomes between Malaysia and the chosen reference agency under the New Route. For generic and biosimilar products, the proposed indications and posology shall be in line with the Malaysian reference product.

** A different container closure system may only be considered if supported by robust justification and supporting data.

3.4     All manufacturing, packaging, testing, and batch release sites for both drug product and the drug substance are identical to those approved by the chosen reference agency. A secondary repacker that has not been approved by the chosen reference agency may be considered, provided that appropriate justification is provided. Any such secondary repacker must hold a valid GMP certificate recognized by NPRA, such as one issued by a PIC/S member authority.

3.5     For generic medicines/hybrid, the comparator product used for the bioequivalence (BE) study should be the same as the Malaysia Comparator Product. If a BE study submitted to the National Pharmaceutical Regulatory Agency (NPRA) via this route was conducted at a BE centre not listed under the NPRA compliance programme or outside the NPRA validity period, a BE Study Desktop Audit application is not required. However, evidence of the chosen reference agency’s assessment of the BE study must be provided during the evaluation of the application.

3.6     A product that has been approved under exceptional circumstances such as conditional marketing authorisation (e.g. the present state of scientific knowledge is insufficient to provide comprehensive information) or equivalent approval process is not eligible for this pathway. Additionally, products requiring a more stringent assessment as a result of differences in local disease patterns and/or medical practices (e.g. some anti-infectives) will not qualify under this pathway.

 

4. REGULATORY REQUIREMENTS

4.1     Dossier Submission

a)  The applicant shall submit a dossier identical in content to that approved by the chosen reference agency, together with a cover letter confirming participation in the pilot study under the New Route.

b)  A Declaration of Sameness by the Product Registration Holder (refer Appendix I) shall be submitted, confirming that:

• The dossier content is identical to the chosen reference agency-approved dossier; and
• No data have been added, modified, substituted, or omitted except to meet Malaysian-specific requirements such as ASEAN Stability Data, labeling, and Risk Management Plan.

c)  The unredacted assessment report from the chosen reference agency must be submitted during screening. For products approved by the US FDA, the Public Assessment Report, including the question-and-answer (Q&A) document, may be submitted under this route. In cases where the assessment report is not available during screening, the report may be submitted within two (2) weeks after payment confirmed; failing which, the application cannot be considered under this pilot.

4.2     Evidence of approval

Evidence of approval by the chosen reference agency shall be provided in the form of approval letter or equivalent document. For products approved by the chosen reference agency with post-market commitments, the corresponding post-market commitments shall apply, and the applicant is required to provide full details of the commitments imposed.

 4.3     Product Labelling Requirements

Product labelling shall comply with Malaysian regulatory requirements as stipulated in the Drug Registration Guidance Document (DRGD).

 4.4     Risk Management Plan (RMP)

4.4.1   Where applicable, the Risk Management Plan approved by the chosen reference agency shall be implemented in Malaysia without modification.

4.4.2   The applicant shall submit:

a)  the chosen reference agency-approved RMP;

b)  a declaration confirming that no modification has been made to the RMP.

c)  Malaysia-Specific Annex (MSA)

4.4.3   NPRA may require additional risk minimisation measures where justified based on local public health considerations.

4.5     Stability Data (ASEAN Climatic Zone IVb), where applicable

4.5.1   Stability study should comply with the ASEAN Guidelines on Stability Study of Drug Product and the category-specific stability requirements stipulated in the DRGD.

4.5.2   A minimum of 12 months real time and 6 months accelerated stability data respectively should be provided at the point of submission.

4.6     Declarations

The applicant shall submit signed declarations, as set out in Appendix I, confirming the following:

• that the dossier is identical to that approved by the chosen reference agency;
• acknowledgement that any undisclosed discrepancy may result in regulatory action; and
• that the proposed indication for the product does not require a more stringent assessment based on Malaysia’s local disease patterns and/or medical practices.

4.7     Cover Letter

A cover letter describing the application and clearly stating the intention to participate in this pilot study must be attached under E14.                         

 

5.      TIMELINE

5.1     The administrative processing regulatory timeline for applications submitted under this pathway is sixty (60) working days, commencing from the confirmation of payment following acceptance of the screening.

5.2     The timeline excludes clock-stops attributable to applicant response time.

5.3     The maximum number of correspondences between NPRA and the applicant under this route shall be limited to three (3) rounds.

 

6.      GENERAL PROVISIONS

NPRA retains the authority to:

• reject applications that do not meet the eligibility criteria or regulatory requirements; and
• take regulatory action to safeguard public health.