Bioequivalence and Bioavailability Forum

mittyri
★★

Russia,
2024-09-14 22:24
(128 d 19:42 ago)

Posting: # 24199
Views: 1,663

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?

CHMP/QWP/708282/2018. Draft guideline on quality and equivalence of topical products.
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.

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Kind regards,
Mittyri

Helmut
★★★

Vienna, Austria,
2024-09-18 10:22
(125 d 07:45 ago)

@ mittyri
Posting: # 24201
Views: 1,323

Patience…

Post reply

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.

❝ 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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

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

Ohlbe ★★★ France, 2024-09-18 12:26 (125 d 05:41 ago) @ Helmut Posting: # 24202 Views: 1,318	MWP Post reply
	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 ★★★ Vienna, Austria, 2024-10-03 13:44 (110 d 04:23 ago) @ Ohlbe Posting: # 24210 Views: 1,017	Final & published Post reply
	Dear Ohlbe and Mittyri, it was published last Monday (see there). — Dif-tor heh smusma 🖖🏼 Довге життя Україна! Helmut Schütz The quality of responses received is directly proportional to the quality of the question asked. 🚮 Science Quotes

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

Patience…

MWP

Final & published