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akinapally ☆ 2012-05-03 16:23 (5151 d 15:32 ago) Posting: # 8499 Views: 4,055 |
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Dear please give clear idea, ambiguity observed in this regard Which regulatory agencies provide facility approvals for conducting/submitting BA/BE studies. E.g. If CRO not having facility approval like (WHO, MOH Turkey or ANVISA) can we do study and can able to file for approval? |
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Helmut ★★★   Vienna, Austria, 2012-05-03 16:56 (5151 d 14:58 ago) @ akinapally Posting: # 8500 Views: 3,522 |
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Dear akinapally! ❝ Which regulatory agencies provide facility approvals for conducting/submitting BA/BE studies. ❝ E.g. If CRO not having facility approval like (WHO, MOH Turkey or ANVISA) Add Jordan Food and Drug Administration. Note that no facility approval process exists in the European Union and associated members states (Norway, Iceland, Liechtenstein). The same holds for Switzerland. You have to adher to the rules of GCP implemented in national drug laws. ❝ can we do study and can able to file for approval? Yes. Some European countries have a 100% inspection policy if a study is submitted to them as the reference member state in a MRP. So expect to see one of these guys sooner or later. — Dif-tor heh smusma 🖖🏼 Довге життя Україна! ![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png) Helmut Schütz ![[image]](https://static.bebac.at/img/CC by.png) The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes |
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Dr_Dan ★★ Germany, 2012-05-03 17:35 (5151 d 14:19 ago) @ Helmut Posting: # 8503 Views: 3,594 |
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Dear akinapally and Helmut If you pass a GLP inspection your site gets a GLP certificate since this inspection focuses on your system whereas a GCP inspection focuses on a specific study in order to assess conditions, practices or processes that affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. That's the big difference. As Helmut explained EU authorities can not issue such certificates as there is no legal base for this (see EMEA/INS/GCP/197226/2005). If you pass a GCP inspection it only tells you that the data obtained in the specific inspected study are valid and you will get an inspection report and nothing else. Kind regards Dan Edit: Document linked. [Helmut] — Kind regards and have a nice day Dr_Dan |
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Helmut ★★★ Vienna, Austria, 2012-05-03 18:03 (5151 d 13:52 ago) @ Dr_Dan Posting: # 8504 Views: 3,568 |
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Dear Dan! I agree 100%. Jordan’s FDA is particular since last year they refused to assess an application before they get the “GCP approval” of the CROs. One of the studies in the package was inspected by the Austrian authority and the lab was GLP-certified. Such a requirement is not stated in their own “Law of clinical studies”… One veiled lady of the JFDA asked about such a certificate at two conferences I was attending. Members of EMA’s PK Working Party told her that such a procedure does not (did not / will not) exist. Shaking her head in disbelief she was obviously not happy with the answer. I was the chairman that day and gave this example: Murder is against law but would you go to the ministry of justice and expect to obtain a certificate stating “Mr X is not a murderer”? Didn’t seem funny to her.  — 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 |
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ElMaestro ★★★ Denmark, 2012-05-03 23:27 (5151 d 08:28 ago) @ Dr_Dan Posting: # 8508 Views: 3,595 |
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Dear Dr_Dan, ❝ If you pass a GLP inspection your site gets a GLP certificate since this inspection focuses on your system whereas a GCP inspection focuses on a specific study in order to assess conditions, practices or processes that affect the rights, safety or well-being of the subjects and/or the quality and integrity of the data. That's the big difference. I agree but I see one additional level of complexity. I think we need to distinguish between system inspections and study inspections, and certifying bodies versus non-certifying bodies. If a lab passes the inspection from a certifying body then, yes, a GLP certifcate may be issued. The inspection will be of the system type, but the inspector is of course likely to ask for specific examples from studies along the way. In some countries GLP inspectors are only available from the certifying bodies which may not have anything to do with the Drug Agency. Sometimes drug agencies have their own GLP inspectors who accordingly don't certify the labs but 'just' inspect them. Most (all??) EU GCP inspections at the moment are study-linked, but the same is not the case with FDA inspections, I think. FDA also do GCP system audits. Along the same lines I don't think the EU statutes provide for non-system GCP inspection only. System GCP insps are possible but rare, perhaps due to budget constraints?! Finally, on basis of recent experience from my audits I hafta say that if I had 17 trillion billion euros that I could donate to good causes then GLP/GCP inspection at NMA's would receive a fairly decent portion. — Pass or fail! ElMaestro |
Ing. Helmut Schütz