{"id":28196,"date":"2018-08-08T01:00:00","date_gmt":"2018-08-09T03:54:12","guid":{"rendered":"http:\/\/www.05921.net\/index.php\/2018\/08\/09\/fda%e7%bb%86%e8%83%9e%e5%9f%ba%e5%9b%a0%e6%b2%bb%e7%96%97%e4%ba%a7%e5%93%81%e7%9b%91%e7%ae%a1%e6%83%85%e5%86%b5\/"},"modified":"2018-08-09T11:54:14","modified_gmt":"2018-08-09T03:54:14","slug":"fda%e7%bb%86%e8%83%9e%e5%9f%ba%e5%9b%a0%e6%b2%bb%e7%96%97%e4%ba%a7%e5%93%81%e7%9b%91%e7%ae%a1%e6%83%85%e5%86%b5","status":"publish","type":"post","link":"https:\/\/www.05921.net\/index.php\/28196\/","title":{"rendered":"FDA\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u76d1\u7ba1\u60c5\u51b5"},"content":{"rendered":"
\n

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\u5212\u91cd\u70b9\u4e86\uff01\u7f8e\u56fdFDA\u5173\u4e8e\u53ef\u590d\u5236\u9006\u8f6c\u5f55\u75c5\u6bd2\u68c0\u6d4b\u5f81\u6c42\u610f\u89c1\u7a3f\u7684\u89e3\u8bfb<\/span><\/a>\uff09\u505a\u4e86\u6df1\u5ea6\u89e3\u8bfb\u3002\u501f\u8fd9\u4e2a\u673a\u4f1a\uff0c\u5c0f\u7f16\u4e3a\u5927\u5bb6\u7cfb\u7edf\u68b3\u7406\u7f8e\u56fdFDA\u5173\u4e8e\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u7684\u76d1\u7ba1\u60c5\u51b5\u3002<\/h2>\n


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\u6839\u636eFDA\u5b98\u7f51\u7684\u4fe1\u606f\uff0c\u7ec6\u80de\u6cbb\u7597\u4ea7\u54c1\u5305\u62ec\u7ec6\u80de\u514d\u75ab\u6cbb\u7597\u3001\u80bf\u7624\u75ab\u82d7\u53ca\u5176\u5b83\u7528\u4e8e\u6cbb\u7597\u76ee\u7684\u7684\u81ea\u4f53\u6216\u5f02\u4f53\u7ec6\u80de\uff08\u5305\u62ec\u9020\u8840\u5e72\u7ec6\u80de\u3001\u80da\u80ce\u5e72\u7ec6\u80de\u3001\u6210\u4f53\u5e72\u7ec6\u80de\u7b49\uff09\u3002\u4eba\u7c7b\u57fa\u56e0\u6cbb\u7597\u662f\u6307\u901a\u8fc7\u6ce8\u5c04\u9057\u4f20\u7269\u8d28\u6765\u8c03\u63a7\u7279\u5b9a\u57fa\u56e0\u7684\u8868\u8fbe\u6c34\u5e73\uff0c\u4ee5\u8fbe\u5230\u6cbb\u7597\u76ee\u7684\u3002<\/span><\/p>\n


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\u76ee\u524d\uff0c\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u7531FDA\u7684\u751f\u7269\u5236\u54c1\u8bc4\u4f30\u548c\u7814\u7a76\u4e2d\u5fc3\uff08Center for Biologics Evaluationand Research\uff0cCBER\uff09\u76d1\u7ba1\uff0c\u5177\u4f53\u8d1f\u8d23\u673a\u6784\u662fCBER\u4e0b\u5c5e\u7684\u7ec6\u80de\u3001\u7ec4\u7ec7\u548c\u57fa\u56e0\u6cbb\u7597\u529e\u516c\u5ba4\uff08Office of Cellular\uff0cTissue and Gene Therapies\uff0cOCTGT\uff09\u3002\u53e6\u5916\uff0c\u9488\u5bf9\u8fd9\u7c7b\u4ea7\u54c1\u6709\u7279\u5b9a\u7684\u4e13\u5bb6\u59d4\u5458\u4f1a\uff0c\u753113\u4f4d\u5177\u6709\u6295\u7968\u6743\u7684\u59d4\u5458\u7ec4\u6210\uff08\u5305\u62ec\u4e3b\u5e2d\uff09\uff0c\u59d4\u5458\u4f1a\u6210\u5458\u5e94\u5f53\u662f\u7ec6\u80de\u3001\u7ec4\u7ec7\u548c\u57fa\u56e0\u6cbb\u7597\u65b9\u9762\u7684\u4e13\u5bb6\u3002\u6cd5\u89c4\u65b9\u9762\uff0c\u548c\u5176\u4ed6\u836f\u54c1\u4e00\u81f4\uff0c\u4f9d\u636ePublic Health Service Act\u548c\u8054\u90a6Food Drug and Cosmetic Act\u8fd9\u4e24\u4e2a\u6cd5\u6848\u3002<\/span><\/p>\n

\"FDA\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u76d1\u7ba1\u60c5\u51b5\"<\/p>\n


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\u884c\u4e1a\u6307\u5357<\/span><\/strong><\/p>\n

\u81ea1998\u5e74\u53d1\u5e03\u9996\u4e2a\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u884c\u4e1a\u6307\u5357\u4ee5\u6765\uff0cFDA\u9646\u7eed\u53d1\u5e03\u4e86\u51e0\u5341\u4e2a\u6307\u5357\uff0c\u76ee\u524d\u5b98\u7f51\u4e0a\u663e\u793a\u7684\u4e3a30\u4e2a\u3002\u5176\u4e2d\uff0c\u90e8\u5206\u6307\u5357\u7ecf\u8fc7\u66f4\u65b0\u5b8c\u5584\uff0c\u4e5f\u6709\u4e00\u4e9b\u6307\u5357\u56e0\u4e0d\u518d\u9002\u7528\u800c\u64a4\u9500\u3002<\/span><\/p>\n


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\u5c0f\u7f16\u5bf9\u8fd930\u4e2a\u6307\u5357\u8fdb\u884c\u521d\u6b65\u5206\u7c7b\uff0c\u5927\u81f4\u53ef\u4ee5\u5206\u4e3a6\u7c7b\uff08\u6307\u5357\u5217\u8868\u89c1\u6587\u672b\uff09\uff1a\uff081\uff09\u7ec6\u80de\u548c\u57fa\u56e0\u6cbb\u7597\u7684\u4e00\u822c\u539f\u5219\u3002\u5171\u8ba14\u4e2a\u6307\u5357\uff0c\u6d89\u53ca\u603b\u5219\u3001\u6709\u6548\u6027\u8bc4\u4f30\u3001\u52a8\u7269\u5b9e\u9a8c\u548c\u65e9\u671f\u4e34\u5e8a\u8bd5\u9a8c\uff1b\uff082\uff09\u57fa\u56e0\u6cbb\u7597\u3002\u5171\u8ba112\u4e2a\u6307\u5357\uff0c\u5728\u6240\u6709\u7c7b\u522b\u4e2d\u6570\u91cf\u6700\u591a\uff0c\u6d89\u53caCMC\u3001RCR\u68c0\u6d4b\u548c\u53d7\u8bd5\u8005\u8ddf\u8e2a\uff08\u8fd93\u5757\u5747\u542b\u65b0\u8001\u4e24\u4e2a\u7248\u672c\uff09\u3001\u8131\u843d\u7814\u7a76\u3001\u8f7d\u4f53\u8bbe\u8ba1\u3001\u73af\u5883\u8bc4\u4f30\u53ca3\u7c7b\u75be\u75c5\uff08\u8840\u53cb\u75c5\u3001\u773c\u79d1\u3001\u7f55\u89c1\u75c5\uff09\uff1b\uff083\uff09\u7ec6\u80de\u6cbb\u7597\u3002\u5171\u8ba16\u4e2a\u6307\u5357\uff0c\u6d89\u53caCMC\u3001\u4f9b\u4f53\u53ca4\u7c7b\u4ea7\u54c1\uff08\u6cbb\u7597\u7c7b\u764c\u75c7\u75ab\u82d7\u3001\u819d\u5173\u8282\u3001\u5fc3\u808c\u548c\u80f0\u5c9b\uff09\uff1b\uff084\uff09\u6700\u5c0f\u5316\u64cd\u4f5c\u7ec6\u80de\u7c7b\u4ea7\u54c1\u3002\u5171\u8ba15\u4e2a\u6307\u5357\uff0c\u6d89\u53ca\u81ea\u4f53\u4f7f\u7528\u53ca\u5f02\u4f53\u4f7f\u7528\u7684\u80ce\u76d8\/\u8110\u5e26\u6765\u6e90\u7684\u9020\u8840\u5e72\u7ec6\u80de\uff1b\uff085\uff09\u518d\u751f\u533b\u5b66\u7597\u6cd5\u3002\u5171\u8ba12\u4e2a\u6307\u5357\uff0c\u5173\u4e8e\u6cbb\u7597\u4e25\u91cd\u75be\u75c5\u7597\u6cd5\u7684\u52a0\u901f\u5ba1\u8bc4\u53ca\u76f8\u5173\u533b\u7597\u5668\u68b0\u7684\u76d1\u7ba1\uff1b\uff086\uff09\u6cbb\u7597\u7c7b\u86cb\u767d\u7684\u514d\u75ab\u539f\u6027\u68c0\u6d4b\u3002\u5c0f\u7f16\u89c9\u5f97\u5f52\u5230\u8fd9\u91cc\u7565\u6709\u4e0d\u59a5\u3002<\/span><\/p>\n


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\u5728\u8fd9\u4e9b\u6307\u5357\u4e2d\uff0c\u6700\u8ba9\u4eba\u5173\u6ce8\u7684\u662f351\u548c361\u7c7b\u4ea7\u54c1\u7684\u5212\u5206\uff0c\u524d\u8005\u6309\u836f\u7269\u7533\u62a5\uff0c\u540e\u8005\u4e34\u5e8a\u4e0a\u53ef\u4ee5\u76f4\u63a5\u4f7f\u7528\u3002\u56fd\u5185\u5bf9\u5e72\u7ec6\u80de\u7597\u6cd5\uff0c\u4e00\u76f4\u6709\u6309\u836f\u7269\u8fd8\u662f\u533b\u7597\u6280\u672f\u76d1\u7ba1\u7684\u4e89\u8bba\uff0c\u80cc\u666f\u5c31\u5728\u4e8e\u6b64\u3002\u76ee\u524d\uff0c\u56fd\u5185\u5916\u4e00\u4e9b\u5e72\u7ec6\u80de\u516c\u53f8\u7ed9\u60a3\u8005\u4f7f\u7528\u672a\u7ecf\u6279\u51c6\u7684\u5e72\u7ec6\u80de\u7597\u6cd5\uff0c\u94bb\u7684\u5c31\u662f\u8fd9\u4e2a\u6240\u8c13\u7684\u7a7a\u5b50\u3002\u5176\u5b9e\uff0cFDA\u5bf9361\u7c7b\u4ea7\u54c1\u6709\u4e25\u683c\u8981\u6c42\uff0c<\/span>\u6838\u5fc3\u6709\u4e09\u70b9\uff1a\u81ea\u4f53\u4f7f\u7528\u3001\u672a\u7ecf\u4f53\u5916\u57f9\u517b\u3001\u539f\u4f4d\u4f7f\u7528<\/strong><\/span>\u3002\u524d\u4e24\u70b9\u5bb9\u6613\u6ee1\u8db3\uff0c\u6700\u540e\u4e00\u70b9\u5f80\u5f80\u88ab\u4e0d\u6b63\u89c4\u7684\u673a\u6784\u6709\u610f\u7ed5\u8fc7\uff08\u5982\u8102\u80aa\u7ec4\u7ec7\u5206\u79bb\u7684\u5e72\u7ec6\u80de\u7528\u4e8e\u8001\u5e74\u75f4\u5446\u75c7\u7684\u6cbb\u7597\uff09\uff0c\u628a\u5e72\u7ec6\u80de\u5305\u88c5\u6210\u4e07\u80fd\u7684\u7075\u4e39\u5999\u836f\u3002\u76ee\u524d\uff0cFDA\u6b63\u5728\u52a0\u5927\u5bf9\u8fd9\u4e9b\u5e72\u7ec6\u80de\u8bca\u6240\u7684\u67e5\u5904\u548c\u6574\u987f\u529b\u5ea6\u3002351\u548c361\u7c7b\u4ea7\u54c1\u5982\u4f55\u5212\u5206\uff0c\u53c2\u7167\u4e0b\u9762\u8fd9\u5f20\u6d41\u7a0b\u56fe\u4fbf\u4e00\u76ee\u4e86\u7136\u3002<\/span><\/p>\n

\"FDA\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u76d1\u7ba1\u60c5\u51b5\"<\/p>\n


<\/span><\/p>\n

\u5df2\u4e0a\u5e02\u4ea7\u54c1<\/span><\/strong><\/p>\n

\u6839\u636e\u5b98\u7f51\u7684\u4fe1\u606f\uff0c\u76ee\u524dFDA\u5171\u6279\u51c619\u4e2a\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\uff08\u4e0d\u542b\u6279\u51c6\u540e\u9000\u5e02\u7684\uff0c\u5982FDA\u9996\u4e2a\u6279\u51c6\u7684\u81ea\u4f53\u8f6f\u9aa8\u7ec6\u80de\u4ea7\u54c1Carticel\uff09\uff0c\u5305\u62ec\u53bb\u5e74\u6279\u51c6\u7684\u4e24\u4e2aCAR-T\u836f\u7269\u548c1\u4e2a\u57fa\u56e0\u6cbb\u7597\u836f\u7269\u3002\u5176\u4e2d\uff0c\u8110\u8840\u6765\u6e90\u7684\u9020\u8840\u5e72\u7ec6\u80de\u7c7b\u4ea7\u54c1\uff08\u76f8\u5f53\u4e8e\u56fd\u5185\u7684\u8110\u5e26\u8840\u5b58\u50a8\uff09\u6700\u591a\uff0c\u4e3a8\u4e2a\u3002\u53e6\u5916\uff0cProvenge\u662f\u4e00\u79cd\u81ea\u4f53\u6811\u7a81\u72b6\u7ec6\u80de\u764c\u75c7\u75ab\u82d7\uff0c\u9002\u5e94\u75c7\u662f\u524d\u5217\u817a\u764c\u3002\u56fd\u5185\u7684\u4e09\u80de\u96c6\u56e2\u901a\u8fc7\u6536\u8d2d\uff0c\u83b7\u5f97\u8be5\u4ea7\u54c1\uff0c\u4f46\u5176\u5386\u53f2\u9500\u552e\u4e1a\u7ee9\u5e76\u4e0d\u7406\u60f3\u3002<\/span><\/p>\n

\"FDA\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u4ea7\u54c1\u76d1\u7ba1\u60c5\u51b5\"<\/p>\n


<\/span><\/p>\n

\u5c0f\u7ed3<\/span><\/strong><\/p>\n

\u5c0f\u7f16\u8ba4\u4e3a\uff0cFDA\u5bf9\u7ec6\u80de\u57fa\u56e0\u6cbb\u7597\u7c7b\u4ea7\u54c1\u6709\u4e00\u5957\u76f8\u5bf9\u5b8c\u6574\u7684\u76d1\u7ba1\u4f53\u7cfb\uff0c\u5e76\u6839\u636e\u6280\u672f\u53d1\u5c55\u60c5\u51b5\u4e0d\u65ad\u66f4\u65b0\uff0c\u4ece\u4ea7\u54c1\u7814\u53d1\u7684\u5404\u4e2a\u73af\u8282\u7ed9\u4e88\u4f01\u4e1a\u6307\u5bfc\uff0c\u5bf9\u4e8e\u5de5\u827a\u6210\u719f\u3001\u98ce\u9669\u6536\u76ca\u6bd4\u53ef\u4ee5\u63a5\u53d7\u7684\u4ea7\u54c1\u5219\u5927\u80c6\u6279\u51c6\u4e0a\u5e02\uff0c\u5728\u5168\u7403\u8d70\u5728\u524d\u5217\uff0c\u503c\u5f97\u6211\u56fd\u5b66\u4e60\u548c\u501f\u9274\u3002<\/span><\/p>\n


<\/span><\/p>\n

\u6307\u5357\u5217\u8868<\/span><\/strong>
\u4e00\u822c\u539f\u5219<\/span><\/p>\n

1. Considerationsfor the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry. 6\/2015<\/span><\/p>\n

2. Guidancefor Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products. 11\/2013<\/span><\/p>\n

3. Guidancefor Industry: Potency Tests for Cellular and Gene Therapy Products. 1\/2011. <\/span><\/p>\n

4. Guidancefor Industry: Guidance for Human Somatic Cell Therapy and Gene Therapy. 3\/1998<\/span><\/p>\n


<\/span><\/p>\n

\u57fa\u56e0\u6cbb\u7597<\/span><\/p>\n

5. Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Draft Guidance for Industry. July 2018<\/span><\/p>\n

6. LongTerm Follow-up After Administration of Human Gene Therapy Products; Draft Guidance for Industry. July 2018<\/span><\/p>\n

7. Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up; Draft Guidance for Industry. July 2018<\/span><\/p>\n

8. Human Gene Therapy for Hemophilia; Draft Guidance for Industry. July 2018<\/span><\/p>\n

9. Human Gene Therapy for Rare Diseases; Draft Guidance for Industry. July 2018<\/span><\/p>\n

10. Human Gene Therapy for Retinal Disorders; Draft Guidance for Industry. July 2018<\/span><\/p>\n

11. Recommendationsfor Microbial Vectors Used for Gene Therapy; Guidance for Industry. 09\/2016<\/span><\/p>\n

12. Designand Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry. 8\/2015<\/span><\/p>\n

13. Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry. 3\/2015<\/span><\/p>\n

14. Guidancefor FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs). 4\/2008<\/span><\/p>\n

15. Guidance for Industry: Gene Therapy Clinical Trials-Observing Subjects for Delayed Adverse Events. 11\/2006<\/span><\/p>\n

16. Guidance for Industry; Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors. 11\/2006<\/span><\/p>\n


<\/span><\/p>\n

\u7ec6\u80de\u6cbb\u7597<\/span><\/p>\n

17. Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs). 4\/2008<\/span><\/p>\n

18. Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry. 8\/2007<\/span><\/p>\n

19. Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines. 10\/2011.<\/span><\/p>\n

20. Guidance for Industry: Preparation of IDEs and INDs for Products Intended to Repair or Replace Knee Cartilage. 12\/2011.<\/span><\/p>\n

21. Guidance for Industry: Cellular Therapy for Cardiac Disease. 10\/2010.<\/span><\/p>\n

22. Guidance for Industry: Considerations for Allogeneic Pancreatic Islet Cell Products. 9\/2009<\/span><\/p>\n


<\/span><\/p>\n

\u6700\u5c0f\u5316\u64cd\u4f5c\u7c7b\u7ec6\u80de\u4ea7\u54c1<\/span><\/p>\n

23. Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff. Updated: December 2017<\/span><\/p>\n

24. Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Guidance for Industry. November 2017<\/span><\/p>\n

25. Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFRPart 1271; Guidance for Industry. 9\/2017<\/span><\/p>\n

26. Guidance for Industry: BLA for Minimally Manipulated, Unrelated Allogeneic Placental\/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System.3\/2014. <\/span><\/p>\n

27. INDApplications for Minimally Manipulated, Unrelated Allogeneic Placental\/UmbilicalCord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System – Guidance forIndustry and FDA Staff. 3\/2014.<\/span><\/p>\n


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\u518d\u751f\u533b\u5b66\u7597\u6cd5<\/span><\/p>\n

28. Evaluationof Devices Used with Regenerative Medicine Advanced Therapies; Draft Guidancefor Industry. November 2017<\/span><\/p>\n

29. Expedited Programs for Regenerative Medicine Therapies for Serious Conditions; Draft Guidance for Industry. November 2017<\/span><\/p>\n

\u5176\u4ed6<\/span><\/p>\n

30. Draft Guidance for Industry: Assay Development for Immunogenicity Testing of Therapeutic Proteins. 12\/2009<\/span><\/p>\n


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Armstrong\u3001\u533b\u836f\u5c40\u5916\u4eba\u3001Fairy\u3001<\/span>Jone\u3001<\/span>\u4e1c\u80dc\u897f\u725b\u3001Alpharesearcher\u3001MT\u3001\u767e\u8349\u3001Irene\u3001<\/span>Self Renew\u3001\u86cb\u767d\u5de5\u4eba\u3001At.Zhou\u3001Julia\u3001\u6e38\u65b9\u548c\u5c1a\u3001Grand\u3001\u5915\u9633\u6b66\u58eb\u3001\u5403\u74dc\u7fa4\u4f17\u3001Nathan\u3001\u795e\u7ecf\u5143\u3001Clear\u516e\u3001\u5357\u5c71\u5357<\/span><\/span><\/p>\n

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