EC 726/2004 の第 5 条第 3項の定 CHMP が作成したヒト用医 …

1 2021 1 29 EMA/409815/2020 EC 726/2004 5 3 CHMP / Domenico Scarlattilaan 6 1083 HS Amsterdam The Netherlands +31 (0)88 781 6000 European Medicines Agency, 2021. EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 2/16 .. 3 1.. 3 2. call for review .. 4 3. MAH 1 2 .. 5 4.. 6 5. 1 / 2 .. 7 6.. 8 7.. 8 8. MAH .. 9 9.. 10 10.. 10 11.. 12 12.. 13 13.. 13 14. MAA .. 14 15. MA.

2 15 16. CEP ASMF API MAH .. 15 17. 5 3 .. 15 18.. 16 EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 3/16 EC 726/2004 5 3 CHMP MAH API FP ICH M7(R1) cohort of concern( 1 MAH 2019 9 5 3 CHMP API 1,2 MAH 1 / 2 3 5 3 CHMP API Q2 5 3 CHMP EMA/189634/2019 2019 9 19 N- 1 2 1.)

3 MAH/ OTC 1 2 EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 4/16 Q10 Q12 MAH/ 2001/83/EC 23 I (EC) 726/2004 16 MAH/ API FP N- API FP FP 2001/83/EC 46 f GMP GMP MAH/ 5 3 API API Q2 2. call for review 2019 9 API MAH 5 3 CHMP 5 3 CHMP CMDh CMDh Questions & Answers on Biologicals 3 1 MAH API FP EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 5/16 2 MAH MAH 3 MAH

4 Q3 2001/83/EC 31 3. MAH 1 2 1 2019 9 26 MAA API 2021 3 31 1 API 2021 7 1 1 MAH 1 API FP 2 Q6 API MAH 1 2 FP API MAH FP API FP 1 API FP MAH 1 1 1 MAH

5 EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 6/16 1 2 2 Q6 API 2 3 Q13 2022 9 26 API 2 3 Q13 2023 7 1 API API 3 2 MAH Q10 2 1 Q10 ng ppm MAH EMA CMDh 4.

6 1. NaNO2 2. DMF DMAc NMP NaNO2 3. API EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 7/16 4. 5. 6. 7. 8. 9. Referral under Article 31 of Directive 2001/83/EC for ranitidine 2001/83/EC 31 6 3 10.

7 FP FP 11. API FP FP 5 3 CHMP 5. 1 / 2 1 2 MAH API FP MAA EMA CMDh 3 Org. Process Res. Dev. 2020, 24, 12, 2915 2926. EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 8/16 6. MAH MAH MAH ICH Q9 FMEA FMECA 7.

8 MAH/ API FP ICH Q9 ICH M7 5 3 CHMP API FP MAH/ API/FP MAH/ Q4 API MAH/ 5 3 CHMP API / FP MAH/ Q8 MAH 1 Q3 EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 9/16 8.

9 MAH MAH 2 FP FP API API API MAH FP API 10% 3 3 Official Medicines Control Laboratories European Directorate for the Quality of Medicines & HealthCare (EDQM ) API/FP LoQ LoQ / MS/MS DMF NDMA EC 726/2004 5 3 CHMP / EMA/409815/2020 Page 10/16 EDQM 5 3 CHMP 9.

10 LoQ LoQ AI LoQ AI 30% LoQ AI 10% AI 1 10. ICH M7 (R1) N- cohort of concern ( ) AI [TTC] ug/day AI 10 1 AI ICH M7 (R1) 5 3 CHMP LTL ICH S9 N- ICH Q3A(R2) ICH Q3B(R2) ICH S9 N- ICH M7(R1)