Polynucleotides: Approval in Europe, Korea, USA and Russia
Table of Contents
In short: How polynucleotides are regulated varies greatly by country. In Europe and Switzerland, they are considered medical devices and are monitored accordingly. In South Korea, they have been established for years, and "salmon DNA" is now standard. In the USA, however, polynucleotides as injections for aesthetics are not approved – only topical products are sold as cosmetics there. In Russia, preparations such as Plinest are registered and very common. (As of 2026.)
At alestetics® at Zurich HB: We work with polynucleotides from PolyPhil™, usually in 3 sessions. PolyPhil™ costs CHF 500 per ampoule here, the 3-session plan CHF 1’200. First, we measure your skin in the free AURA 3D skin analysis.
Anyone looking into polynucleotides will find contradictory statements: sometimes it's stated they are "not approved," and other times they are in use everywhere. Both can be true – depending on which country is being discussed. We'll sort it out.
First off: What does "approved" actually mean?
An important point first. Countries regulate such products differently. In many regions, injectable polynucleotides are considered Medical device – then they undergo a conformity assessment and can be used with appropriate labelling. In other systems, such as the USA, the hurdle for injectable preparations is a Medicinal product type authorisation, which these products haven't had until now. That's why the same preparation can be available in one country and not permitted in another.
Europe and Switzerland: Medical Devices
In the European Union, injectable polynucleotides are considered medical devices and bear a CE mark in accordance with the applicable Medical Device Regulation. They are therefore an integral part of aesthetic medicine.
In Switzerland, medical devices are supervised by Swissmedic. CE-marked products that meet Swiss requirements are used. For practitioners, this means: polynucleotides are regularly available here and are used in a medical-aesthetic context. The one we use PolyPhil™ is a CE-certified medical device.
Korea: The Motherland of "Salmon DNA"
South Korea is a leader in polynucleotides. Preparations like Rejuran have been established, intensively used, and studied there for years. The Korean regulatory authority oversees this market, and "salmon DNA" treatment is part of everyday cosmetic medicine. A large part of the international recognition of polynucleotides can be attributed to the Korean market.
UK: Not approved as an injection
The situation in the USA is different – and this surprises many. Injectable polynucleotides are not approved for aesthetic use there (as of 2026). What is available are topical products: creams and serums with related active ingredients (PDRN) are sold as cosmetics, because cosmetics in the USA do not require prior approval.
This leads to a paradoxical situation: a trend originating in Korea and Europe is not available as a treatment in the USA. American women who want polynucleotides therefore often go abroad. It is a good example of how "not approved in the USA" does not mean "ineffective" - it simply reflects a different regulatory system.
Russia: registered and very common
In Russia, polynucleotide preparations such as Plinest are registered and well-established in the market. The treatment – often called "biorevitalization with polynucleotides" there – is widespread and popular. Consequently, there is a great familiarity with the name Plinest, which regularly leads to questions when customers come to Switzerland. We explain why it is PolyPhil instead of Plinest here in the article. Plinest or PolyPhil?.
A look into history: PDRN since 1994
The basic idea is not new. The related DNA fraction PDRN was already approved in Italy in 1994 for wound healing – for example, for poorly healing wounds. From this medical application, today's use in skin rejuvenation has developed. Therefore, polynucleotides are not a trendy product without history, but an active principle with decades of foundation.
The overview
| Region | Status (as at 2026) |
|---|---|
| EU | Medical device with CE marking, established |
| Switzerland | Medical device under Swissmedic supervision, available |
| Korea | Established for years, very widespread |
| United States of America | Not approved for injection; only topical products as cosmetics |
| Russia | registered, widely used (incl. Plinest) |
What that means for you in Zurich
In Switzerland, you can receive polynucleotides within a regulated framework. In the alestetics® At the clinic at Zurich HB, we work with the CE-certified PolyPhil™. Whether the treatment is right for you, we will clarify in advance in the free AURA 3D skin analysis.
Read on
- Plinest or PolyPhil? The Mastelli connection
- What are polynucleotides?
- Polynucleotides or hyaluronic acid: which is better for skin quality?
Are polynucleotides approved in Switzerland?
Are polynucleotides approved by the FDA?
Why are polynucleotides not available in the USA, but are in Europe?
Since when has this active ingredient existed?
Is Plinest approved in Russia?
Written by
Alexandra Stroganova
Founder of alestetics® · Pre-ageing specialist
Medical cosmetologist · Certificate of competence V-NISSG · Lymph therapist · since 2021
Alexandra founded alestetics® in Zurich in 2021. She works according to the ‘pre-ageing’ philosophy: improving skin quality early on, rather than trying to conceal it later.
Find out more about Alexandra and the team →