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REPOR T

This paper presents some important topicscosmetics brands
should be aware of when registering or filing their cosmetics
for general trade in China.

HAVE A CLEAR STRATEgy ABouT youR
DOMESTIC RESpONSIBLE AgENT (DRA)
Cosmetics brands must have a local representative in China
that is a Chinese entity in order to be approved for general
sales. Known as the Domestic Responsible Agent, the DRA
submits the regulatory approval application and is the point-
of-contact for the brand with the regulator for continuing
compliance and communications.
Applicants have 3 broad options (see Figure 1):
1. Own subsidiary
2. Third-party agency service
3. Distributor.
Establishing your own subsidiary is an appropriate
long-term strategy but it can be expensive and BE AWARE oF SPECIAL VS gENERAL
time-consuming until volumes are large. The subsidiary CoSMETICS APPRoVAL PRoCESSES
must also employ compliance staff who are up to date Cosmetics are classified into “special” and “general” cosmetics
with regulations and can respond to regulator requests. for the purposes of approval for general trade in China.
Selecting a distributor as your DRA initially appears as • “Special” cosmetics include sun protection, hair dyes, hair
the easy option, but the author cautions companies to perming, anti-hair loss, and freckle removal and whitening,
do so only after fully considering the available options. and cosmetics that claim new effects.
As the DRA is the entity that submits the application dossier • “general” cosmetics are cosmetics other than “special”
which contains detailed and confidential information about cosmetics.
the products, such as the formula and production process, “general” cosmetics go through a filing or notification
this choice has major intellectual property protection risks. process that in the author’s experience takes 3-6 months,
What’s more, the DRA also controls the online account which including document preparation and sample shipment to
must be set up to submit the approvals. This means that you China for local testing. Their certificates are valid indefinitely.
will continue to be wholly reliant on the distributor’s continued Whereas “Special” cosmetics go through a registration
cooperation for adding/deleting arrival ports and consignees process that takes 8-12 months in the author’s experience.
(especially other distributors), or to change the DRA itself. Their registration must be renewed every 5 years.
Selecting a third-party agency is a sensible option to retain For all cosmetics categories, the approval process
your independence and better manage IP risks. has an order to follow: firstly appoint the DRA, as legal
It’s a neutral solution allowing you to maintain full control representative person for overseas companies as described
over your NMPA online account, and guarantees above, secondly submit all required documentation
your independence for future decisions, including and test reports to the provincial MPA or NMPA (special
adding/deleting ports and consignees, or DRA changes. cosmetics). Once the acceptance is published online, the
Another practical point to consider: the overarching newly approved cosmetics can be imported into China.
regulator for cosmetics in China is the National Medical
Product Administration or NMPA, however there are
also provincial-level regulators called Medical Product
Administration (MPA), such as the Beijing or Hubei MPA.
This is important because notifications or filings of “general”
cosmetics (see next point to understand this definition)
are made to one of the provincial-level MPAs.
However, if you wish to change your DRA for
a given cosmetic product from one province
to another this will require the DRA in the first province
to cancel the product’s notification certificate.
Then you will need to apply to re-notify in the new province.
This clearly means you need a fully cooperative
DRA from the outset.

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