ICH Q4指导原则简介
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摘要
本文简要介绍了国际人用药品注册技术协调会(ICH)Q4指导原则提出的背景意义、组织架构、附件的制定流程、附件内容和使用方法,以期为我国药监机构加入ICH后的中国药典的编制提供帮助。
引文
[1] ICH. Specifications:Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products:Chemical Substances Q6A[EB/OL].[2018-12-24].http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q6A/Step4/Q6Astep4. pdf.
[2] ICH. Specifications:Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q6B[EB/OL].[2018-12-24]. http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Step4/Q4B_Guideline. pdf.
[3] ICH. Q4 Pharmacopoeias[EB/OL].[2018-12-24].http://www. ich. org/products/guidelines/quality/article/quality-guidelines. html.
[4] ICH. Frequently Asked Questions Q4B:Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions[EB/OL].[2018-12-24]. http://www. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Q4B_Frequently_Asked_Questions_26.April. pdf.
[5] ICH. ICH Q4B Expert Working Group[EB/OL].[2018-1-23]. http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Presentation/Q4B_Presentations. pdf.
[6] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B[EB/OL].[2018-12-24]. http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Step4/Q4B_Guideline. pdf.
[7] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on residue on ignition/sulphated ash general chapter Q4B Annex 1(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_1/Step4/Q4B_Annex_1_R1_Step4. pdf.
[8] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter. Q4B Annex 2(R1)[EB/OL].[2018-12-24]. https://www.ich. org/fileadmin/Public_Web_Site/ICH Products/Guidelines/Quality/Q4B_Annex_2/Step4/Q4B_Annex_2_R1_Step4. pdf.
[9] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination:Sub-Visible Particles General Chapter.Q4B Annex 3(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH Products/Guidelines/Quality/Q4B_Annex_3/Step4/Q4B_Annex_3_R1_Step4.pdf.
[10] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products:Microbial Enumerations Tests General Chapter Q4B Annex 4A(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_4A/Step4/Q4B_Annex4A_R1_Step4.pdf.
[11] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products:Tests for Specified Micro-Organisms General Chapter Q4B Annex 4B(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_4B/Step4/Q4B_Annex4B_R1_Step4.pdf.
[12] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products:Microbiological Examination of Non-Sterile Products:Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceuticals for Pharmaceutical Use General ChapterQ4B Annex 4C(R1)[EB/OL].[2018-12-24]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_4C/Step4/Q4B_Annex4C_R1_Step4.pdf.
[13] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q4B Annex 5(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_5/Step4/Q4B_Annex5_R1_Step_4.pdf.
[14] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 6[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Q4B_Annex_6_Step_4. pdf.
[15] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 7(R2)[EB/OL].[2018-12-24].https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_7/Step4/Q4B_annex_7_R2_.pdf.
[16] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter Q4B Annex 8(R1)[EB/OL].[2018-12-24].https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_8/Step4/Q4B_Annex_8_R1_Step_4.pdf.
[17] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter Q4B Annex 9(R1)[EB/OL].[2018-12-24].https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_9/Step4/Q4B_Annex_9_R1_Step_4.pdf.
[18] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 10(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_10/S tep4/Q4B_Annex_10_R1_Step_4.pdf.
[19] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter Q4B Annex 11[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_11/Step4/Q4B_Annex_11_Step_4.pdf.
[20] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter Q4B Annex 12[EB/OL].[2018-12-24].https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_12/Step4/Q4B_Annex_12_Step_4.pdf.
[21] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density of Powders General Chapter Q4B Annex 13[EB/OL].[2018-12-24]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_13/Q4B_Annex_13_Step_4.pdf.
[22] 1CH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter Q4B Annex 14[EB/OL].[2018-12-24]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_annex_14/Q4B_Annex_14_Step_4.pdf.
[23]张伟,丁建华,李茂忠,等.药品注册的国际技术要求[M].第1版,北京:中国医药科技出版社,2012:31-142.
[2] ICH. Specifications:Test Procedures and Acceptance Criteria for Biotechnological/Biological Products Q6B[EB/OL].[2018-12-24]. http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Step4/Q4B_Guideline. pdf.
[3] ICH. Q4 Pharmacopoeias[EB/OL].[2018-12-24].http://www. ich. org/products/guidelines/quality/article/quality-guidelines. html.
[4] ICH. Frequently Asked Questions Q4B:Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions[EB/OL].[2018-12-24]. http://www. ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Q4B_Frequently_Asked_Questions_26.April. pdf.
[5] ICH. ICH Q4B Expert Working Group[EB/OL].[2018-1-23]. http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Presentation/Q4B_Presentations. pdf.
[6] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Q4B[EB/OL].[2018-12-24]. http://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Step4/Q4B_Guideline. pdf.
[7] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on residue on ignition/sulphated ash general chapter Q4B Annex 1(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_1/Step4/Q4B_Annex_1_R1_Step4. pdf.
[8] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Extractable Volume of Parenteral Preparations General Chapter. Q4B Annex 2(R1)[EB/OL].[2018-12-24]. https://www.ich. org/fileadmin/Public_Web_Site/ICH Products/Guidelines/Quality/Q4B_Annex_2/Step4/Q4B_Annex_2_R1_Step4. pdf.
[9] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Test for Particulate Contamination:Sub-Visible Particles General Chapter.Q4B Annex 3(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH Products/Guidelines/Quality/Q4B_Annex_3/Step4/Q4B_Annex_3_R1_Step4.pdf.
[10] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products:Microbial Enumerations Tests General Chapter Q4B Annex 4A(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_4A/Step4/Q4B_Annex4A_R1_Step4.pdf.
[11] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products:Tests for Specified Micro-Organisms General Chapter Q4B Annex 4B(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_4B/Step4/Q4B_Annex4B_R1_Step4.pdf.
[12] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Microbiological Examination of Non-Sterile Products:Microbiological Examination of Non-Sterile Products:Acceptance Criteria for Pharmaceutical Preparations and Substances for Pharmaceuticals for Pharmaceutical Use General ChapterQ4B Annex 4C(R1)[EB/OL].[2018-12-24]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_4C/Step4/Q4B_Annex4C_R1_Step4.pdf.
[13] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Disintegration Test General Chapter Q4B Annex 5(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_5/Step4/Q4B_Annex5_R1_Step_4.pdf.
[14] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 6[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B/Q4B_Annex_6_Step_4. pdf.
[15] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Dissolution Test General Chapter Q4B Annex 7(R2)[EB/OL].[2018-12-24].https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_7/Step4/Q4B_annex_7_R2_.pdf.
[16] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test General Chapter Q4B Annex 8(R1)[EB/OL].[2018-12-24].https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_8/Step4/Q4B_Annex_8_R1_Step_4.pdf.
[17] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Tablet Friability General Chapter Q4B Annex 9(R1)[EB/OL].[2018-12-24].https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_9/Step4/Q4B_Annex_9_R1_Step_4.pdf.
[18] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Polyacrylamide Gel Electrophoresis General Chapter Q4B Annex 10(R1)[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_10/S tep4/Q4B_Annex_10_R1_Step_4.pdf.
[19] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Capillary Electrophoresis General Chapter Q4B Annex 11[EB/OL].[2018-12-24]. https://www. ich. org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_11/Step4/Q4B_Annex_11_Step_4.pdf.
[20] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Analytical Sieving General Chapter Q4B Annex 12[EB/OL].[2018-12-24].https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_12/Step4/Q4B_Annex_12_Step_4.pdf.
[21] ICH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bulk Density of Powders General Chapter Q4B Annex 13[EB/OL].[2018-12-24]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_Annex_13/Q4B_Annex_13_Step_4.pdf.
[22] 1CH. Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Bacterial Endotoxins Test General Chapter Q4B Annex 14[EB/OL].[2018-12-24]. https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q4B_annex_14/Q4B_Annex_14_Step_4.pdf.
[23]张伟,丁建华,李茂忠,等.药品注册的国际技术要求[M].第1版,北京:中国医药科技出版社,2012:31-142.