THE NMPA DIFFERENTIATES BETWEEN "GENERAL" AND "SPECIAL" COSMETICS

COSMETICS

A China NMPA (National Medical Products Administration) approval is complex and can take from a few months to a year, depending on the specific product. The exact costs and the timeframe depend, among other things, on the type of cosmetics, the ingredients and the tests to be carried out in China.

In China, a distinction is made between "special" and "general" cosmetics.

  • "Special" cosmetics are subjected to more extensive testing as part of the registration. Products include: sunscreen, hair dye, spot removing/whitening, anti-hair loss, hair perming, and cosmetics that claim new effects.
  • Manufacturers of "general" cosmetics have to undergo a filing procedure. "General" cosmetics are those other than "special" cosmetics. More details on the filing procedure can be found in our cosmetics brochure.
  • Baby cosmetics are not considered as a separate category; however, as soon as a product targets babies or children, the cost and the timeframe for the registration tend to be higher due to additional sample tests and application dossier requirements.

A Historical Breakthrough

After three decades of waiting, the Cosmetic Supervision and Administration Regulation (CSAR), the important overarching cosmetics regulation, came into force on January 1, 2021. During the transitional period, the applicants should continue to follow the existing regulations as long as the regulations supporting and interpreting the CSAR have not been released yet or only exist in draft form.

Since January 1, 2021, deodorants, hair growing, depilation, body slimming, and breast enhancement products, which used to be “special” cosmetics, cannot register with NMPA anymore. If products with these functions were registered prior to the introduction of the CSAR, they are granted a transition period of 5 years. During the transition period, production, import and sales can continue. After the transition period, they will not qualify as “special” cosmetics anymore.

From January 1, 2021 onwards, soaps with efficacy claims of “special” cosmetics are required to register as “special” cosmetics and obtain a registration certificate.

According to CSAR, toothpaste will need to be filed as “general” cosmetics in future.

The process of China NMPA filing ("general" cosmetics) and registration ("special" cosmetics) is demanding. Even large companies make mistakes. Cisema provides solutions customised for your products. Our experienced consultants guide you through the entire regulatory process in China until receipt of certificate, including identifying whether your cosmetics are "special" or "general", analysing the formula and packaging for China conformity, and preparing the application documents in Chinese. The NMPA certificate for "special" cosmetics is valid for 5 years, while the certificate for "general" cosmetics is valid indefinitely. Learn more about the process of China NMPA filing and registration including timelines in our brochures.

The DRA for cosmetics is responsible for the registration/filing, supervision of the tests, regulatory aspects during the application for approval, as well as partial responsibility for product safety and post-market surveillance.

Cosmetics manufacturers who intend to appoint a distributor as DRA should be aware of the related risks. Should your distributor refuses to hand over the original certificates to you or does not maintain your NMPA online account according to your wishes, you will unfortunately find yourself in a dependency, which can prevent you from changing the DRA, appointing new distributors, applying for change or renewal of your NMPA certificates and consequently importing your products.

You will learn about the responsibility scope and criteria for choosing the right DRA for your company in our brochures.

🞂 Are you a manufacturer and want to sell your cosmetics in China for the first time?

🞂 You may already sell your cosmetics in China online via CBEC but now wish to enter China via the general trade?

🞂 Are you unsure if your ingredients are China compliant?

🞂 Would you like to know how much time and costs you have to anticipate for the China NMPA registration or filing of your cosmetics?

🞂 Are you unsure who to appoint as your Domestic Responsible Agent (DRA)?

🞂 Wondering how many test samples you need to provide to Chinese laboratories?

🞂 Would you like to know if the packaging of the test samples must already look like the final product?

🞂 Do you have any concerns about revealing the exact manufacturing method and ingredients of your cosmetics as part of the registration?

🞂 You may already have certification for your cosmetics, but will it expire soon?

🞂 You don't know how a recently released regulation affects you?

🞂 Do you have a question regarding the QMS (quality management system) requirements in China?

Which services can Cisema support you with?

Cisema offers a full scope of services to companies seeking NMPA approval, ensuring the most efficient route to China NMPA filing and registration for your cosmetics.

Our range of services includes the following services:

  • Single ingredient check
  • Formula check
  • New ingredient registration obligation introduction

🞂 Category check ("special" and "general")

🞂 Full-cost calculation including timeline

🞂 “General” cosmetic filing

🞂 “Special” cosmetic registration

🞂 Ingredients, claims and packaging review for compliance with Chinese regulations

🞂 Provision of document checklist and templates, including review and advice on the correct completion of the registration documents

🞂 Test sample import and logistics

🞂 Test arrangement and coordination in China

🞂 Translation and notarization of documents into Chinese

🞂 Chinese label drafting according to NMPA requirements

🞂 NMPA application dossier preparation and submission

🞂 Support the technical review and respond to supplementary notice

🞂 Close follow-up and timely response during the whole filing/registration process

🞂 Handover of NMPA certificate

🞂 Advice on applicable legislation and relevant regulations

🞂 Correspondence and coordination between you and the Chinese authorities in technical and cultural terms

🞂 Legal representation in China as DRA for regulatory affairs

🞂 Post-approval regulatory support, e.g.  change applications, DRA changes, and renewals

 

We preferably support companies from the start of the application process, as we believe that major mistakes can be prevented right at the beginning of the China NMPA registration process. Errors in the application usually lead to significant delays and increase in effort and expenses for the applicant.

Find out how we can help your market entry into China. To obtain further relevant information, we recommend our exclusive brochures.

APPOINTING A DOMESTIC RESPONSIBLE AGENT (DRA)

According to NMPA regulations, foreign cosmetics companies shall appoint a legal entity in China as their DRA.

The DRA plays a central role in the approval process and post-market surveillance and should therefore be chosen very carefully. The most important selection criteria are his experience in regulatory matters, related product standards and relationship with test laboratories and the relevant authorities.

Foreign companies usually have three options: 

  • Company's subsidiary in China
  • Distributor
  • Independent professional partner like Cisema

Cosmetic companies should be aware of possible risks and advantages associated with their DRA choice. When using a professional partner, such as Cisema, cosmetics companies preserve full control over their NMPA online account, its maintenance and subsequently the certificates. Certain confidential information, such as the production process and formula, is not shared with distributors. Cosmetics companies preserve the flexibility to change and add distributors at any time. All necessary activities related to post-market surveillance and the reporting of undesirable events are supported by specialists.

Service offer for DRA

Cisema can assume the role of DRA for your cosmetics in China: 

🞂 Apply for and manage the NMPA (National Medical Product Administration) filing system online account.

🞂 Facilitate the communication between the Beijing MPA (Medical Product Administration) and the foreign manufacturer.

🞂 Establish a product quality and safety management and records system together with the foreign manufacturer.

🞂 Convey relevant regulation changes to the foreign manufacturer truthfully and accurately.

🞂 Coordinate the import of the product and maintain sales records in China.

🞂 Create the annual inspection report to meet the annual checking requirements of NMPA.

🞂 Store product samples and records at the DRA office site for potential official Beijing MPA checks.

🞂 Receive information on adverse events due to quality related issues and provide feedback to the foreign manufacturer and report back to the related department of the Beijing MPA.

🞂 Bear joint responsibility for after sales service and product quality together with the foreign manufacturer.

 

Request our service offer if you would like to nominate Cisema as your DRA.

We are at your disposal

Contact

Do not hesitate to contact us if you have further questions or to request a non-binding offer.
You can contact us at +1 (0)773-449 5169 (US & Americas) or + 49 (0)89-4161 7389-00 (EU and worldwide) or via email.

To obtain further relevant information we recommend you
to visit our knowledge area or our registration page for exclusive information brochures.

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