Bioequivalence and Bioavailability Forum • RLD Requirement in all EU region

Compliance
★

India,
2013-06-03 09:43
(4769 d 10:09 ago)

Posting: # 10710
Views: 3,820

RLD Requirement in all EU region [Regulatives / Guidelines]

Dear All,

I have question regarding the selection of reference product for all Europe region. So if I select any reference product which is listed or authorized in UK market then the study conducted for MHRA can be submitted in other region of EU? or we have to select the reference product form each applicable Europe region for submission. we are looking for UK, France, Germany and other region of EU.

Second question is do we have any documentary proof which states that the regulatory criteria (guidance document of EU) of EU and reference product of EU region accepted by the TGA (Australia)for submission or we have to select reference product marketed in Australia only.

With addition to this we have few more market where we would like to work and searching information for Romania,Switzerland, Netherlands, Poland, Malaysia, Philippines, Indonesia,Vietnam

Your valuable suggestion are very well awaited.

Regards,

Compliance

Dr_Dan
★★

Germany,
2013-06-03 11:08
(4769 d 08:45 ago)

@ Compliance
Posting: # 10711
Views: 3,305

RLD Requirement in all EU region

Post reply

Dear Compliance

The product used as reference product in the bioequivalence study should be part of the global marketing authorisation of the reference medicinal product (as defined in Article 6(1) second subparagraph of Directive 2001/83/EC). The selection of the reference product used in a bioequivalence study should be based on assay content and dissolution data and is the responsibility of the Applicant.
In theory you have to perform a BE study with reference product marketed in Australia. In praxis it often is sufficient if you give evidence that the European product is the same as the Australian (qualitative and quantitative composition) and you can use the European BE study.
Romania, Netherlands, Poland = EU, Switzerland non-EU but associated, Malaysia, Philippines, Indonesia, Vietnam = Asia with own regulations.

Kind regards
Dan

Edit: Document linked. [Helmut]

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Kind regards and have a nice day
Dr_Dan

Compliance ★ India, 2013-06-12 10:25 (4760 d 09:28 ago) @ Dr_Dan Posting: # 10774 Views: 3,164	RLD Requirement in all EU region Post reply
	Dear Dr. Dan, Thank you for the same. Regards, Compliance