mittyri
★★  

Russia,
2024-09-14 22:24
(50 d 03:13 ago)

Posting: # 24199
Views: 984
 

 Draft guideline on quality and equivalence of topical products – still stuck? [Regulatives / Guidelines]

Dear All!

may be someone can shed some light on the current status of guideline on quality and equivalence of topical products in EMA jurisdiction1?
The consultation period is over more than 5 years ago and no updates on EMA site so far.
Citing a paper with experts2:

❝ The principles defined in the EMA draft guideline on the quality and equivalence of topical products reflects the current state-of-the-art methods and are similar to those of the US-FDA. These principles have been applied in recent years and some products have been approved, which demonstrates that it is applicable; however, it could be convenient to widen the acceptance range according to the observed variability in the reference product.


Everything is good to go, little amendments required. So what?


  1. CHMP/QWP/708282/2018. Draft guideline on quality and equivalence of topical products.
  2. García-Arieta A. et al. Regulatory Requirements for the Development of Second-Entry Semisolid Topical Products in the European Union. Pharmaceutics. 2023; 15: 601. doi:10.3390/pharmaceutics15020601.

Kind regards,
Mittyri
Helmut
★★★
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Vienna, Austria,
2024-09-18 10:22
(46 d 15:15 ago)

@ mittyri
Posting: # 24201
Views: 785
 

 Patience…

Hi Mittyri,

❝ may be someone can shed some light on the current status of guideline on quality and equivalence of topical products in EMA jurisdiction?

Not me. :-D

❝ The consultation period is over more than 5 years ago and no updates on EMA site so far.

Well, some of the FDA’s guidances are in draft state for 20 years…

❝ Citing a paper with experts:

❝ ❝ […] it could be convenient to widen the acceptance range according to the observed variability in the reference product.


Already proposed in the draft, lines 708–715:

The acceptance criteria for equivalence parameters is that the 90% confidence interval for the ratio of means of the test and comparator products should be contained within the acceptance interval of 80.00 – 125.00%, unless justified.
Wider acceptance criteria for the 90% confidence interval, to a maximum of 69.84 – 143.19, may be accepted in the case of high within-subject or within-donor variability observed with low strength and imited diffusion drug products, and if clinically justified. The procedure in the Guideline on Investigation of Bioequivalence, “Section 4.1.10 Highly variable drugs or drug products” should be followed.


❝ Everything is good to go, little amendments required. So what?

Obviously the MWP (successor of the PKWP) has other priorities.

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Ohlbe
★★★

France,
2024-09-18 12:26
(46 d 13:11 ago)

@ Helmut
Posting: # 24202
Views: 760
 

 MWP

Dear Helmut and Mittyri,

❝ Obviously the MWP (successor of the PKWP) has other priorities.


I don't see it mentioned on the latest version of their 3-year work plan.

Regards
Ohlbe
Helmut
★★★
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Homepage
Vienna, Austria,
2024-10-03 13:44
(31 d 11:53 ago)

@ Ohlbe
Posting: # 24210
Views: 462
 

 Final & published

Dear Ohlbe and Mittyri,

it was published last Monday (see there).

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