Abhay Patil

2021-03-23 08:58
(28 d 12:43 ago)

Posting: # 22289
Views: 370

 Regulatory Submission in Europe in Absence of Reference product [Regulatives / Guidelines]

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

2021-03-23 09:51
(28 d 11:50 ago)

@ Abhay Patil
Posting: # 22290
Views: 324

 Regulatory Submission in Europe in Absence of Reference product

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.
Abhay Patil

2021-03-23 10:00
(28 d 11:41 ago)

@ dshah
Posting: # 22291
Views: 320

 Regulatory Submission in Europe in Absence of Reference product

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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