Newsletter Volume 38, Number 1, 2023


The Pharmacokinetics Society of Japan Newsletter: Regulatory Science Information

1. Guideline Update (Trends from July 2022 to January 2023)

 ICHE8(R1) “General Guidelines for Clinical Trials” was issued by the Ministry of Health, Labour and Welfare of Japan (MHLW).
(, updated February 2, 2023)

International Trends in Regulatory Harmonization Activities ( )

 The International Conference on Harmonization of Pharmaceutical Regulations (ICH) was held in Incheon on November 13-16, 2022.

 Among the three topics of ICH M13: Bioequivalence Studies for Immediate Release Oral Solid Drugs, ICHM13A (generic study design) has reached Step 2 and ICHM13B (biowaiver of different content formulation) will start in January 2023. ICHM15: A concept paper on general principles for Model Informed Drug Development (MIDD) was approved by the General Assembly, which started the discussion of overarching general principles and considerations for the use of MIDD. The next ICH meeting is scheduled to be held face-to-face in Vancouver on June 10-13, 2023.

ICH Guideline (Pharmacokinetics) Development Status ( )
M12 Drug Interaction Studies Step 3 Scheduled for Step 4 in 2024/04
M13. Bioequivalence for Immediate-Release Solid Oral Dosage Forms M13A: Step 2 Scheduled for Step 4 in 2024/05
M13B to be studied in 2023/01 and M13C in 2024/07
M15 Model-informed Drug Development Step 1 Scheduled for 2024Q2/Q3 Step 2
E11A Paediatric Extrapolation Step 3 Scheduled for Step 4 in 2024Q1
S12 S12 Biodistribution for Gene Therapy Product Step 3 Scheduled for Step 4 in 2023/05

Step 4: Adopted as a guideline by the regulatory members of the ICH Annual Meeting. Step 4: Adopted as a guideline by the regulatory members of the ICH Assembly, which will be incorporated into the regulatory framework through the necessary national procedures in each country/region.

Step 3: Expert working groups discuss and revise the draft guideline based on public comments in each country/region.

Step 2: Step 2a: Technical document and Step 2b: Draft guideline are adopted at the Plenary Meeting. Public comments will be made in each country/region.



For details, please refer to the following