shahajan baig
☆    

India,
2021-08-31 14:49
(98 d 05:29 ago)

Posting: # 22556
Views: 1,185
 

 RLD identification in EU region in view of Brexit [Regulatives / Guidelines]

Dear Member,

Hope everyone is safe and healthy in this pandemic situation.

I wanted to know about RLD identification & selection in EU region since we do not have any specific source like in USFDA which provides the orange book data or OGD guidance. Also, we don't have several product-specific guidance in EU regions. Ao in such conditions how can we identify & select RLD in EU region? Also please guide me about how Brexit impacted DCP and CP in EU union for the selection of RLD.

A response will be highly appreciated

Regards,

SHAHAJAN BAIG
dshah
★    

India/United Kingdom,
2021-08-31 16:40
(98 d 03:38 ago)

@ shahajan baig
Posting: # 22557
Views: 1,158
 

 RLD identification in EU region in view of Brexit

Dear Shahajan Baig!
There is no RLD in EU region. Applicant can use a reference medicinal product (RMP) authorized in European reference product or the intended market of application, provided that any other requirements for the application type is fulfilled.
For MHRA after Brexit- please visit https://www.gov.uk/guidance/reference-medicinal-products-rmps
for further information.
Regards,
DShah
Helmut
★★★
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Homepage
Vienna, Austria,
2021-09-24 15:36
(74 d 04:41 ago)

@ dshah
Posting: # 22594
Views: 553
 

 MHRA: No ‘own’ BE GL?

Hi DShah,

» For MHRA after Brexit- please visit https://www.gov.uk/guidance/reference-medicinal-products-rmps

I was curious about the [image] state of affairs.
The MHRA’s website is a mess. Funny enough I discovered this goody. Still the EMA’s BE-GL. I beg your pardon…

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Ohlbe
★★★

France,
2021-09-09 22:55
(88 d 21:23 ago)

@ shahajan baig
Posting: # 22563
Views: 812
 

 RLD identification in EU region in view of Brexit

Dear shahajan baig,

» I wanted to know about RLD identification & selection in EU region since we do not have any specific source like in USFDA which provides the orange book data or OGD guidance.

The reference product is defined in Directive 2001/83/EC, Article 10, 2°(a) as a medicinal product authorised under Article 6, in accordance with the provisions of Article 8. Article 8, 3°(i) states that the application dossier should include results of pharmaceutical (physico-chemical, biological or microbiological) tests, pre-clinical (toxicological and pharmacological) tests and clinical trials.

Practical translation:
- the reference product has to be authorised in the EU;
- it has to be authorised based on a full dossier. You can't use a generic as reference product.

It is quite easy to find out which product is the reference product for those authorised, say, in the past 15 years, especially if they went through the centralised procedure. If you're trying to make a generic of a very old product, you may struggle.

» Also please guide me about how Brexit impacted DCP and CP in EU union for the selection of RLD.

Very simple. You can't take the reference product from the UK market to do a BE trial for an application in the EU. See point 1.3 in this Notice to stakeholders.

Regards
Ohlbe
shahajan baig
☆    

India,
2021-09-10 16:44
(88 d 03:34 ago)

@ Ohlbe
Posting: # 22565
Views: 706
 

 RLD identification in EU region in view of Brexit

Dear Ohlbe,

Thank you so much for your valuable response, additionally I wanted to know if there will be no RLD available in EU region for a parenteral solution so how can we proceed for biowaiver for the particular parenteral product because for biowaiver we need to prove similarity between active substances as per GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **) which states that:

"Bioequivalence studies are generally not required if the test product is to be administered as an aqueous intravenous solution containing the same active substance as the currently approved product, However, if any excipients interact with the drug substance (e.g. complex formation), or otherwise affect the disposition of the drug substance, a bioequivalence study is required unless both products contain the same excipients in very similar quantity and it can be adequately justified that any difference in quantity does not affect the pharmacokinetics of the active substance"

So how would we proceed in such cases?? shall we proceed with an available different dosage form of the same strength??

Regards,

SHAHAJAN BAIG
Helmut
★★★
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Homepage
Vienna, Austria,
2021-09-10 20:22
(87 d 23:56 ago)

@ shahajan baig
Posting: # 22566
Views: 724
 

 No ‘RLD’ in the EEA

Hi Shahajan,

» […] I wanted to know if there will be no RLD available in EU region…

Lacking an ‘Orange Book’, there is no ‘Reference Listed Drug’ in the [image] European Economic Area.
[image] = [image] [image] [image] [image] [image][image] [image] [image] [image] [image] [image] [image] [image] [image] [image] [image] [image] [image][image] [image] [image] [image] [image] [image] [image] [image] [image]
EEA = [image] + [image] [image] [image]
Read Ohlbe’s post again.

» …for a parenteral solution so how can we proceed for biowaiver for the particular parenteral product because for biowaiver we need to prove similarity between active substances as per GUIDELINE ON THE INVESTIGATION OF BIOEQUIVALENCE (CPMP/EWP/QWP/1401/98 Rev. 1/ Corr **) which states that: […]

Can you be more specific? ‘Parenteral’ is any route of administration which is not oral.
Only – given certain conditions – for aqueous intravenous solutions a biowaiver is possible.

» So how would we proceed in such cases?? shall we proceed with an available different dosage form of the same strength??

See above.

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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