BRB ☆ Canada, 2017-07-20 17:44 (2468 d 14:42 ago) Posting: # 17581 Views: 16,897 |
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Hello all, to anyone's knowledge does the CFDA allow for FDA or EMA reference scaling? I tried looking into the current Chinese regulatory documents: http://www.sfda.gov.cn/WS01/CL1751/147583.html but I could not find anything which mentions it, particularly in Annex 3 which seems to focus on the PK and stats analysis. If anyone can provide some guidance, it would be appreciated. Thank you! BRB |
Helmut ★★★ Vienna, Austria, 2017-07-21 00:09 (2468 d 08:17 ago) @ BRB Posting: # 17584 Views: 15,742 |
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— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
BRB ☆ Canada, 2017-07-21 00:33 (2468 d 07:53 ago) @ Helmut Posting: # 17585 Views: 15,769 |
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Thank you Helmut. Finding information about the CFDA requirements is quite a challenge. It makes finding information about ANVISA requirements seem like a walk in the park Do you, or does anyone know where I could find more details about reference scaling for the CFDA? Is it similar to EMA scaling as mentioned in the quoted post? Is there anything in the public domain available that can verify this, or am I asking too much??? Thanks again! BRB |
Shuanghe ★★ Spain, 2017-07-21 20:09 (2467 d 12:16 ago) @ BRB Posting: # 17588 Views: 15,819 |
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Hi, ❝ Finding information about the CFDA requirements is quite a challenge. It makes finding information about ANVISA requirements seem like a walk in the park I'm a native speaker and it's difficult for me to find useful information as well. So I guess it's not the issue of the language. ❝ Do you, or does anyone know where I could find more details about reference scaling for the CFDA? Is it similar to EMA scaling as mentioned in the quoted post? Is there anything in the public domain available that can verify this, or am I asking too much??? Not in public domain but I do have a copy of the appendix 9011 from Chinese Pharmacopeia 2015 that was mentioned in my post. I've sent it to Helmut so if he has some spare time to upload it to guidance collection then you'll have it. I'm not sure if this is the verification you referred to. There's not much new information about BE since the reform from CFDA is quite recent. They do have some training material (given by CFDA staff) which is free to download (rar file), all in Chinese obviously. Both FDA and EMA method was mentioned but they didn't say which one they prefer. Helmut, By the way, I thought about sending the guideline to you by forum's private message but I couldn't find a way to attach any document so I use email instead. Is it so by design or my IT skill need to be improved? — All the best, Shuanghe |
Helmut ★★★ Vienna, Austria, 2017-07-21 20:25 (2467 d 12:01 ago) @ Shuanghe Posting: # 17589 Views: 15,730 |
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Hi Shuanghe, ❝ By the way, I thought about sending the guideline to you by forum's private message but I couldn't find a way to attach any document so I use email instead. Is it so by design or my IT skill need to be improved? Your skils are fine. By design (see there). The forum is under constant attack by bad bots. I block about 25/day (80,000 since Nov 2012). Would need a major rewrite of the forum’s scripts to allow attachments in the contact form and/or uploading binary files. Sorry. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Helmut ★★★ Vienna, Austria, 2017-07-21 21:23 (2467 d 11:03 ago) @ BRB Posting: # 17590 Views: 15,818 |
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Hi BRB, ❝ […] It makes finding information about ANVISA requirements seem like a walk in the park :) I have given up to find sumfink useful at ANVISA’s site. Some of my Portuguese friends told me that the site is terrible. ❝ Do you, or does anyone know where I could find more details about reference scaling for the CFDA? THX to Shuanghe: Appendix 9011. Appetizers (original and translate): 9011 药物制剂人体生物利用度和生物等效性试验指导原则中国药典2015 In short, that’s the EMA’s approach:
— Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Shuanghe ★★ Spain, 2017-07-24 20:47 (2464 d 11:39 ago) @ Helmut Posting: # 17601 Views: 15,589 |
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Hi all, ❝ • The GMR-restriction of 80.00–125.00% (mandatory in all other jurisdictions) is not mentioned. Forgotten? I think they would prefer the word "implied" since most of the contents are just copied from EMA's guideline. — All the best, Shuanghe |
yicaoting ★ NanKing, China, 2017-08-22 18:49 (2435 d 13:37 ago) @ BRB Posting: # 17731 Views: 15,284 |
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❝ To anyone's knowledge does the CFDA allow for FDA or EMA reference scaling? I tried looking into the current Chinese regulatory documents: Hi BRB I work in China. On this issue, from my experience with CFDA, they like to adopt US FDA's RSABE guidance. We have submit such dossier using US FDA's method to CFDA. Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! [Helmut] |
Helmut ★★★ Vienna, Austria, 2017-08-22 18:59 (2435 d 13:27 ago) @ yicaoting Posting: # 17732 Views: 15,376 |
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Hi Zhang Yong, ❝ On this issue, from my experience with CFDA, they like to adopt US FDA's RSABE guidance. ❝ We have submit such dossier using US FDA's method to CFDA. That’s interesting given Shuanghe’s post above and followings – which point towards the EMA’s method. Strange. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
Shuanghe ★★ Spain, 2017-08-29 15:12 (2428 d 17:14 ago) @ Helmut Posting: # 17750 Views: 15,180 |
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Hi Helmut, ❝ That’s interesting given Shuanghe’s post above and followings – which point towards the EMA’s method. Strange. As I mentioned in previous post, initially it seems that CFDA adopted EMA's method by their guideline in 2015 as an appendix of the Chinese Pharmacopeia; however, the newer guideline was published in 2016 and it's basically a copy of FDA's guidance. That's one of the reasons I said that "FDA beats EMA in China". The confusion/uncertainty comes from the fact that, unfortunately, RSABE was only mentioned in 2015 guideline but not in 2016 guideline. Though it's not clear from guideline perspective, in practice, I had a feeling that Zhang Yong might be right about CFDA's preference of FDA method though no one can be sure unless they submitted such method and the dossier was approved. Hi Zhang Yong, From the context I understood that you only submitted dossier to CFDA. What's their opinion? The dossier is approved or are you still waiting for the possible "deficient letter" (or whatever name they call it in china)? For BRB, I think that if you really want to be sure that the correct method is used, it might be worthwhile to contact CFDA. — All the best, Shuanghe |
yicaoting ★ NanKing, China, 2017-08-29 20:51 (2428 d 11:35 ago) @ Shuanghe Posting: # 17752 Views: 15,369 |
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❝ From the context I understood that you only submitted dossier to CFDA. What's their opinion? The dossier is approved or are you still waiting for the possible "deficient letter" (or whatever name they call it in china) Hi Shuanghe Yes, our submission is under review now. But we believe that CFDA will like to accept FDA's method. The drug product is listed on FDA's Drug Product Specific BE Recommendation List. As far as we know, (I am working in a big Pharma in China) CFDA is putting more and more emphasis on learning the list. The reviewer usually gives us suggestion and requirement according to FDA's BE recommendations, especially those drugs are clearly listed and those with more special properties such as HVDs and NTIDs. As you know, a lot of reviewers (such as He Ruyi serves as CSO for CFDA now) come back to CFDA from FDA these years, this definitely will has some influence on the CFDA's attitude to many issues in drug application review. BTW, are you working in China now? |