Abhay Patil
☆    

India,
2021-03-23 08:58
(255 d 08:21 ago)

Posting: # 22289
Views: 6,488
 

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

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
dshah
★    

India/United Kingdom,
2021-03-23 09:51
(255 d 07:28 ago)

@ Abhay Patil
Posting: # 22290
Views: 6,314
 

 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.
Regards,
Dshah
Abhay Patil
☆    

India,
2021-03-23 10:00
(255 d 07:19 ago)

@ dshah
Posting: # 22291
Views: 6,338
 

 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]
drgunasakaran1
★★  
avatar

2021-05-20 07:20
(197 d 10:58 ago)

@ Abhay Patil
Posting: # 22360
Views: 3,221
 

 Regulatory Submission in Europe in Absence of Reference product

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 S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.
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