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Abhay Patil ☆ India, 2021-03-23 09:58 (1397 d 11:56 ago) Posting: # 22289 Views: 8,077 |
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Hi, We would like to know the regulatory submission in Europe in absence of Refrence product in europe. Reference product (RLD) is available in other countries like Singapore, Australia, NZ but not available in Europe (also not in uk ) Its a Fixed dose combination but all Individual dosage are available in Europe both Refernce as well as Generic and also under WEU category Need your guidance to overcome this matter Thanks and regads Abhay Patil |
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dshah ★★ India, 2021-03-23 10:51 (1397 d 11:04 ago) @ Abhay Patil Posting: # 22290 Views: 7,590 |
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Hi Abhay Patil! In absence of Innovator product in EU and UK market for FDC, you may have to do BE against individual drug substance innovator product. Please see Guideline on clinical development of fixed combination medicinal products. Regards, Dshah |
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Abhay Patil ☆ India, 2021-03-23 11:00 (1397 d 10:54 ago) @ dshah Posting: # 22291 Views: 7,638 |
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Thank you for your quick feedback. The Individual product are present in Europe for more than 20 years and their equivalent Generics too available and filed under WEU. so in such case is it necessary to do BABE study Warm regards Abhay Patil 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! [Ohlbe] |
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drgunasakaran1 ★★  2021-05-20 09:20 (1339 d 13:34 ago) @ Abhay Patil Posting: # 22360 Views: 4,497 |
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Dear Abhay Patil, ❝ The Individual product are present in Europe for more than 20 years and their equivalent Generics too available and filed under WEU. so in such case is it necessary to do BABE study Yes. We need to conduct studies even though equivalent Individual Product Generics are available in the EU Market. — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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