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March 10, 2026
Approximately 5 minutes
Guideline for Liposome Drug Product Development in Japan
1. Background and policy intent
Liposome drug products are microvesicles with a lipid bilayer enclosing an aqueous compartment, encapsulating active substances to improve in vivo stability, pharmacokinetics, and intracellular behavior. Issued in March 2016, the guideline promotes appropriate development and prompt patient access by providing pharmaceutical and nonclinical/early clinical study information. It applies to products affecting stability and pharmacokinetics but excludes non-bilayer mixtures. Principles align with ICH guidelines and are applicable to post-marketing issues. Source: https://www.pmda.go.jp/files/000272266.pdf
2. Target products and eligibility types
Target products encapsulate active substances (low-molecular-weight chemicals, nucleic acids, peptides, proteins) in liposomes to influence stability/pharmacokinetics. Eligibility focuses on nanotechnology-based products reducing adverse reactions and improving efficacy via targeted delivery (e.g., EPR effect or ligands). Types include passive/active targeting liposomes. Source: https://www.pmda.go.jp/files/000272266.pdf
3. Consultation pathway before approval
Consultation with PMDA is recommended for individual development. The guideline outlines pre-approval considerations for CMC, nonclinical studies, and FIH trials, emphasizing QbD per ICH Q8(R2)/Q11. Source: https://www.pmda.go.jp/files/000272266.pdf
4. Approval application and review expectations
Applications require detailed characterization of quality attributes (particle size, zeta potential, loading efficiency). Review focuses on control strategies, stability per ICH Q1A(R2)/Q5C, and comparability for changes per ICH Q5E. Expectations include validated methods and risk-based assessments. Source: https://www.pmda.go.jp/files/000272266.pdf
5. Procedure after approval (post-marketing obligations)
Post-approval involves monitoring lipid degradation and quality attributes. The appendix addresses manufacturing changes requiring comparability assessments, potentially including nonclinical/clinical studies. Source: https://www.pmda.go.jp/files/000272266.pdf
6. Practical considerations and positioning versus other pathways
Practically, use multiple lots for characterization and in vitro tests reflecting physiological conditions. Versus standard drugs, liposomes require specific PK measurements (encapsulated/unencapsulated). Positioning integrates with ICH for global consistency. Source: https://www.pmda.go.jp/files/000272266.pdf
7. Effective date
Issued as PSEHB/ELD Notification No. 0328-19 on March 28, 2016. Source: https://www.pmda.go.jp/files/000272266.pdf
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