Table 1.

Introduction status of risk-based approaches for NLR.

Country	Vaccines	PDMPs, antitoxins, and others
Indonesia	Introduced in 2001, lot release is required for both domestic and imported vaccines. Vaccine lot release includes appearance test, vaccine vial monitoring, label, leaflet, packaging review, SP, and certificate of analysis.	Lot release is not introduced for PDMPs, but the GMP of those products are strengthened. However, the guidelines for lot release of PDMPs is going to be discussed.
Japan	Introduced in 2009 (Reduction of test items based on risk assessment). It is under discussion to introduce reduction of testing frequency based on risk assessment.	Not introduced for PDMPs. However, the elimination of double-checking at the NCL in each test item is introduced based on past test results, the status of accuracy control such as availability of standard and reference products, and situation of standardization of each test item as appropriate.
Korea	Introduced in 2016 (Risk level 1, 2a, 2b, and 3)	Introduced in 2016 (Risk level 1, 2a, 2b, and 3)
Malaysia	Introduced in 2021, lot release requirements for locally manufactured vaccines (Phase 1, 2, and 3) include review of SP/test report and physical appearance test/other tests in OCABR/selected tests.	Introduced in 2021, lot release requirements for locally manufactured PDMPs (Phase 1, 2, and 3) include review of SP/test report and physical appearance test/other tests in OCABR/selected tests.
Philippines	Introduced in 2023 under FDA Order No. 2023-0302 (for plan testing of vaccines). Review of SP, Recognition/Acceptance of lot release from responsible NRA/NCL. All vaccines are procured/imported and mostly WHO prequalified.	Not introduced. Lot release certification covers only vaccines, toxoids, and immunoglobulins.
Vietnam	Introduced in 2019 (Risk level 1, 2, and 3) Review SP, inspect cold chain, and perform test in specification following yearly testing policy approved by NCL.	Introduced in 2019 (Risk level 1, 2, and 3) Review SP, inspect cold chain, and perform test in specification following yearly testing policy approved by NCL.