Regulations for Registration of Medicinal Products - Legislative History - Laws & Regulations Database of The Republic of China (Taiwan)

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Legislative History

Title：	Regulations for Registration of Medicinal Products CH
Announced Date：	2005-01-07
Amended Date：	2023-04-27
Category：	Ministry of Health and Welfare（衛生福利部）
Attachment：	Appendix1：Maximum Drug Package Size Dosage.pdf Appendix 1-1：Prescription Drug’s Package Insert Format.pdf Appendix 2：Documents for the Application forDrug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdf Appendix 3：Technical Documents for the Application for Drug Review and Registration of New Drugs, New Dosage Forms, New Administration Doses and New Unit Strengths.pdf Appendix 4：Documents for the Application for Drug Review and Registration of Generics.pdf Appendix 5：Technical Documents for the Application for Drug Review and Registration of Generics in the Dosage Forms of Liposome or Transdermal Absorption.pdf Appendix 6：Documents for the Application for Drug Review and Registration of Bio-Pharmaceutical Products.pdf Appendix 7：Technical Documents for the Application of Drug Review and Registration of Bio-Pharmaceutical Products.pdf Appendix 8：Documents for the Application of Drug Review and Registration of API.pdf Appendix 9：Technical Documents for the Application of Drug Review and Registration of API.pdf Appendix 10：Documents Required for the Application for Drug Review and Registration of Radiopharmaceutical Drugs.pdf Appendix 11：Technical Documents Required for the Application for Drug Review and Registration of New Drugs, New Dosage Forms and New Dose of Radiopharmaceutical Drugs.pdf Appendix 12.PDF Appendix 12.doc Appendix 12-1：Matters that Should be Applied for Changes of Manufacturing Process and Batch Size of Drug Product.pdf Appendix 12-2：Documents for the Application of Registration Changes of Manufacturing Process and Batch Size of Drug Product.pdf Appendix 13.pdf

1. Full text including 110 articles formulated and promulgated by the Executive Yuan, the Department of Health Order Wei-Shu-Yao No. 0930339211, on January 7, 2005; The Regulations shall be effective on the day of the publication.
2. Text of article 91 and 109 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0940000931, on February 25, 2005.
3. Text of article 74, 78 and 104 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0940327378, on September 15, 2005.
4. Article 40 related appendix 4 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0970312361, on May 13, 2008.
5. Text of article 24, 28 and article 42 related appendix 8, 9 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0970319688, on July 24, 2008.
6. Text of article 86 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0970003012, on September 12, 2008.
7. Text of article 22-1 added by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0980303366, on February 13, 2009.
8. Text of article 15 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0980360944, on July 20, 2009.
9. Text of article 38-1 added by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0980362080, on September 3, 2009.
10. Text of article 12 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0980360474, on September 14, 2009.
11. Text of article 6, 7, 9~11, 14, 17, 20, 24, 27, 28, 30, 37, 44, 45, 47, 48, 50, 52~55, 57, 58, 60~68, 70,73, article 39 related appendix 2, 3, article 40 related appendix 4, article 41 related appendix 6, 7, article 42 related appendix 8, article 43 related appendix 10 and appendix 11 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 0991412567, on December 9, 2010.
12. Text of article 6, 7, 38 and 38-1 amended; article 38-2~38-4 added by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1011401930, on May 8, 2012.
13. Text of article 72 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1011405753, on July 30, 2012.
14. Text of article 10,46,70 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1021405369, on July 30, 2013.
15. Text of article 74,77,78,83,91,104,109 amended by the Ministry of Health and Welfare Wei-Bu-Zhong-Zi No. 1021880127, on August 30, 2013.
16. Article 41 related appendix 6 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1031400506, on February 14, 2014.
17. Text of article 73 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1031403161, on May 7, 2014.
18. Text of article 46 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1041402706, on April 15, 2015.
19. Text of article 9, article 39 related appendix 2, article 40 related appendix 4 amended by the Executive Yuan, the Department of Health Order Shu-Shou-Shi No. 1041403238, on May 7, 2015.
20. Text of article 11, 12, 17, 20, 22-1, 32, 49, 53, 54, 55, 60, 73, 110, article 39 related appendix 2, article 40 related appendix 4, article 42 related appendix 8 amended by the Ministry of Health and Welfare Order Bu-Shou-Shi No. 1051400499, on April 6, 2016.
21. Text of article 74~76, 77, 78~109, 110, and the title of section 4, chapter 3 amended; article 76-1~76-8, 77-1, and 109-1 added by the Ministry of Health and Welfare Order Wei-Bu-Zhong No. 1061860969, on July 31, 2017.
22. Amended on December 5, 2017
23. Text of article 92-1 added by the Ministry of Health and Welfare Order Wei-Bu-Zhong No. 1061861892, on January 4, 2018.
24. Promulgared by Ministry of Health and Welfare Order Bu-Shou-Shi Zi No.1071410196, on February 14,2019
25. Text of article 74, 77-1 amended by the Ministry of Health and Welfare Order Wei-Bu-Zhong No. 1081861289, on October 7, 2019.
26. Text of article 75, 98, 104, 105, article 92 related appendix 13 amended; article 104-1 and 105-1 added by the Ministry of Health and Welfare Order Wei-Bu-Zhong No. 1091860732, on June 12, 2020.
27. Promulgared by Ministry of Health and Welfare Order Bu-Shou-Shi Zi No.1101407692, on September 14,2021
28. Text of Article 75, 81, 92, 92-1, 104-1 and 109-1 amended by the Ministry of Health and Welfare Order Wei-Bu-Zhong No. 1101861231 on September 28, 2021
29.Promulgared by Ministry of Health and Welfare Order Bu-Shou-Shi Zi No.1121401757, on April 27,2023.