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Tina ★ India, 2013-04-22 13:40 (4423 d 17:36 ago) Posting: # 10452 Views: 7,237 |
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Should a European Reference Product be always used for MRP/DCP? If the innovator is the European Reference Product and is not available in a member state, can the generic (which had compared itself with the ERP) available in the member state be used for MRP/DCP application with the member state as the RMS? If the generic is marketed only in one member state, it would have been the company's decision to market in that MS. However, they have still compared with the innovator? Does EMA require only a innovator to be compared as the reference? Thanks in advance for the guidance. |
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Helmut ★★★   Vienna, Austria, 2013-04-22 15:09 (4423 d 16:07 ago) @ Tina Posting: # 10455 Views: 6,700 |
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Hi Tina! ❝ Should a European Reference Product be always used for MRP/DCP? Yes – or more precise: “must” not “should”. ❝ If the innovator is the European Reference Product… There is no “European Reference Product” – unless the innovator product was authorized by the Centralized Procedure. In an MRP/DCP the reference marketed in any country of the EEA can be used. ❝ … and is not available in a member state, can the generic (which had compared itself with the ERP) available in the member state be used for MRP/DCP application with the member state as the RMS? No way.* ❝ If the generic is marketed only in one member state, it would have been the company's decision to market in that MS. However, they have still compared with the innovator? ❝ Does EMA require only a innovator to be compared as the reference? Yes. For details see Section 4.1.2 of the BE GL.
— 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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Tina ★ India, 2013-09-24 16:08 (4268 d 15:08 ago) @ Helmut Posting: # 11551 Views: 5,970 |
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Dear Helmut, Thank you for the clarification. Instead of MRP/DCP, if the product were to be marketed only in one country and if the innovator isnt available in that country, are we justified in showing BE with the generic which is available in the country (which has showed BE with the innovator?) and is available in the market for more than 8 years. If the innovator product is a capsule and the proposed test are tablets and if innovator in not available in the proposed country, doing a BE study in the existing generic (tablets ) will reduce formulation (capsule vs tablet) associated any change in the release of the active from the formulation. I look forward to your reply |
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Helmut ★★★ Vienna, Austria, 2013-09-25 00:53 (4268 d 06:23 ago) @ Tina Posting: # 11554 Views: 6,004 |
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Hi Tina, ❝ Instead of MRP/DCP, if the product were to be marketed only in one country and if the innovator isnt available in that country, are we justified in showing BE with the generic which is available in the country (which has showed BE with the innovator?) and is available in the market for more than 8 years. No. By definition BE is based on a comparative bioavailability study where the reference is the innovator. See this old slide. You have two generics, the first test is BE to the innovator but the second test is not. If you would use the first test as the reference, test 2 would be “bioequivalent”. ❝ If the innovator product is a capsule and the proposed test are tablets… In the EU you can show BE for pharmaceutical alternatives as well. No problem. ❝ …if innovator in not available in the proposed country, doing a BE study in the existing generic (tablets ) will reduce formulation (capsule vs tablet) associated any change in the release of the active from the formulation. No way (see above). Even if you want to go for a national application, you can use a reference with a MA in any country of the EEA. If the innovator is not marketed in any member state, bad luck. — 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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Tina ★ India, 2013-09-27 20:02 (4265 d 11:14 ago) @ Helmut Posting: # 11570 Views: 5,815 |
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Dear Helmut, Thank you for the explanation. For the product on which I am working currently, the innovator is not available in the EU. Only 2 generics are available. The generics would have got their MA based on their BE with the reference. Considering the non-availability of reference, is it justified to use one of the generics as comparator? |
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Helmut ★★★ Vienna, Austria, 2013-09-28 11:40 (4264 d 19:36 ago) @ Tina Posting: # 11573 Views: 5,876 |
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Hi Tina, did you read my previous post? If yes, how did you come to the conclusion that it would be acceptable to refer to another generic? — 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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The Outlaw Torn ★ Europe, 2013-09-30 10:18 (4262 d 20:58 ago) (edited on 2013-09-30 13:01) @ Tina Posting: # 11576 Views: 5,832 |
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Dear Tina, I think you are indeed out of luck. I see two potential options. First, if you can find a reference product in another non-EU market and can provide evidence that it was based on the same global development that the European reference was based on when it was avaiable, then you can try to compare against this non-EU sourced reference product. Second, the only other option I see is going the well-established use route. However, well-established use applications apparently now require a BE study (as per scientific advice). Yes, it doesn't make sense, but... As you can see, both options appear to be long shots. But good luck nonetheless. Outlaw Torn |
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Tina ★ India, 2013-10-01 16:27 (4261 d 14:49 ago) @ The Outlaw Torn Posting: # 11581 Views: 5,790 |
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Dear Outlaw Torn, If we were to go through well-established use route and if a BE study is required, what will be the comparator product? Only generics are available as the reference is not available globally. Though not applicable in my case, how do we find the global development of a product other than the MAH. Sometimes the products are approved in different countries at different times.....different batch numbers.....different manufacturing process. I know a product which is approved in the EU and is still under assessment in the US. |
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The Outlaw Torn ★ Europe, 2013-10-02 10:03 (4260 d 21:13 ago) @ Tina Posting: # 11586 Views: 5,782 |
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❝ If we were to go through well-established use route and if a BE study is required, what will be the comparator product? Only generics are available as the reference is not available globally. Hi Tina, That's one of the reasons I said it doesn't make sense. For old products the reference product may no longer on the market, having been withdrawn due to a plethora of generics. And by asking for a BE study it takes the term "well-established use" to the level of now being an oxymoron (ie. by definition, it can no longer be well-established if it needs a BE study). My advice, just don't get scientific advice from Denmark on this as nice and helpful as those folks tend to be. ❝ Though not applicable in my case, how do we find the global development of a product other than the MAH. Maybe not global, but you have to show a European connection and sometimes it takes detective work to accomplish that. For example, we had to show that an Australian product was based on the same development as the European reference. In a convoluted way, we were able to find documentation that the European and New Zealand products were both manufactured in the same plant in Europe, and we were able to link the Australian product by way of showing that New Zealand distributed this particular drug to both its market and Australia. In addition, the quality people had some types of diffraction data that I don't understand, etc, etc, and microphotographs of the bead coating thickness, etc, etc. At the end of the day, EMA accepted that both came from the same development and we got a tap on the back from the guys upstairs.  |
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Tina ★ India, 2013-10-03 13:37 (4259 d 17:39 ago) @ The Outlaw Torn Posting: # 11594 Views: 5,746 |
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Dear outlaw Torn, Submission plan as a well-established use is a good plan as the reference was first licensed in the EU in 1960s. Will opt that route and see what happens next. Thank you for sharing means to find global marketing authorisation of the product. The plan should prevent duplicating the studies with different references from different ICH countries. Has anyone got experience with FDA accepting a study with EU reference and pharmaceutically proving global MAH Status. Kind regards, Tina. |
Ing. Helmut Schütz