Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Dear All Associates,
This is my first day and first post, a warm Hello to all.
I have noticed USFDA has recently modified selection procedure for RLD products in the Orangebook Database.
Do EMEA / MHRA has formal procedure for selection of Reference products for BE studies.
To be more specific I want to know which product to be used as a Reference Product for Pracetamol 500 mg soft gelatin capsule intended for registration in EU market.
Regards.

There is no European equivalent to the Orange Book, however the MHRA are extremely helpful in advising on reference products.  Normally it's possible to register copy products by performing a BE study against a reference product under the provisions for generic medicines. Paracetamol is an outlier because it's so old that it doesn't have a reference product so this route isn't available.  Instead you will have to submit an application via the well established use route which absolves you from doing a BE study but obliges you to submit a thorough review of the scientific literature (peer-reviewed published studies on preclinical and clinical  efficacy and safety) on paracetamol.  As usual, it's essential to take advice from an EU consultant and speak to the MHRA at an early stage.

------------------------------
Steve Binysh
Acta Pharma Services Ltd
RUISLIP
United Kingdom
------------------------------

Original Message:
Sent: 16-Nov-2017 04:06
From: Anonymous Member
Subject: Selection procedure for EU Reference Prouct

This message was posted by a user wishing to remain anonymous

Dear All Associates,
This is my first day and first post, a warm Hello to all.
I have noticed USFDA has recently modified selection procedure for RLD products in the Orangebook Database.
Do EMEA / MHRA has formal procedure for selection of Reference products for BE studies.
To be more specific I want to know which product to be used as a Reference Product for Pracetamol 500 mg soft gelatin capsule intended for registration in EU market.
Regards.

Dear Steve,
Many thanks for the reply, I understood that paracetamol very old molecule and surely application can be considered as WEU criteria.
In this case a suitable choice could be to use oldest approval product if it is available in market.
A more precise logical question can we use soluble/effervescent tablet in the BE study for registration of Capsule (Soft), as both are belonging to Immediate Release dosage forms.

Again Many Thanks for your prompt reply.

------------------------------
Tushar Premchandani PHD


------------------------------

Original Message:
Sent: 17-Nov-2017 05:38
From: Steve Binysh
Subject: Selection procedure for EU Reference Prouct

There is no European equivalent to the Orange Book, however the MHRA are extremely helpful in advising on reference products.  Normally it's possible to register copy products by performing a BE study against a reference product under the provisions for generic medicines. Paracetamol is an outlier because it's so old that it doesn't have a reference product so this route isn't available.  Instead you will have to submit an application via the well established use route which absolves you from doing a BE study but obliges you to submit a thorough review of the scientific literature (peer-reviewed published studies on preclinical and clinical  efficacy and safety) on paracetamol.  As usual, it's essential to take advice from an EU consultant and speak to the MHRA at an early stage.

------------------------------
Steve Binysh
Acta Pharma Services Ltd
RUISLIP
United Kingdom

Original Message:
Sent: 16-Nov-2017 04:06
From: Anonymous Member
Subject: Selection procedure for EU Reference Prouct

This message was posted by a user wishing to remain anonymous

Dear All Associates,
This is my first day and first post, a warm Hello to all.
I have noticed USFDA has recently modified selection procedure for RLD products in the Orangebook Database.
Do EMEA / MHRA has formal procedure for selection of Reference products for BE studies.
To be more specific I want to know which product to be used as a Reference Product for Pracetamol 500 mg soft gelatin capsule intended for registration in EU market.
Regards.

Dear Tushar,

You suggest that the oldest approved product on the EU market should be used as reference product under an abridged application via the generic route. However, this is only possible if the reference product was originally licenced under the European legislation dating from 1968 so this possibility is not available if the reference is older than this date.

I sincerely recommend you ask an EU agency for advice on this matter as selction of an inappropriate legal basis for filing the marketing application will lead to a refusal to accept the dossier.

Steve

------------------------------
Steve Binysh
Acta Pharma Services Ltd
RUISLIP
United Kingdom
------------------------------

Original Message:
Sent: 17-Nov-2017 05:38
From: Steve Binysh
Subject: Selection procedure for EU Reference Prouct

There is no European equivalent to the Orange Book, however the MHRA are extremely helpful in advising on reference products.  Normally it's possible to register copy products by performing a BE study against a reference product under the provisions for generic medicines. Paracetamol is an outlier because it's so old that it doesn't have a reference product so this route isn't available.  Instead you will have to submit an application via the well established use route which absolves you from doing a BE study but obliges you to submit a thorough review of the scientific literature (peer-reviewed published studies on preclinical and clinical  efficacy and safety) on paracetamol.  As usual, it's essential to take advice from an EU consultant and speak to the MHRA at an early stage.

------------------------------
Steve Binysh
Acta Pharma Services Ltd
RUISLIP
United Kingdom

Original Message:
Sent: 16-Nov-2017 04:06
From: Anonymous Member
Subject: Selection procedure for EU Reference Prouct

This message was posted by a user wishing to remain anonymous

Dear All Associates,
This is my first day and first post, a warm Hello to all.
I have noticed USFDA has recently modified selection procedure for RLD products in the Orangebook Database.
Do EMEA / MHRA has formal procedure for selection of Reference products for BE studies.
To be more specific I want to know which product to be used as a Reference Product for Pracetamol 500 mg soft gelatin capsule intended for registration in EU market.
Regards.