According to the “Cosmetics Supervision and Administration Regulations,” the filing of imported cosmetics refers to the process of imported cosmetics manufacturers filing with the State Council Drug Administration and submitting the corresponding information and supporting documents to obtain approval. Specifically contains the following steps:
1.After signing the agent filing contract, foreign manufacturers must provide basic information and samples for inspection as soon as possible to carry out the subsequent filing work. The preparation time may vary for each manufacturer, but usually, it takes about 15 days to complete this task.
Regarding preparing the basic information, various documents and certificates are required, such as the company’s business license, the product’s quality management system certification, the product’s production license, etc. These documents and certificates are the critical basis for proving the strength of the company and the quality of the products and must be guaranteed to be accurate and reliable. In addition, you also need to prepare product technical documents, including product manuals, product specifications, product formulations, and so on.
Regarding preparing samples for inspection, it is necessary to prepare them according to the standards and requirements agreed in the agent declaration contract. Usually, they must be sent to the laboratory for testing within the specified time. In this process, the quality of the samples must be guaranteed to ensure the accuracy and reliability of the test results.
2.In conducting the pre-declaration risk assessment, foreign manufacturers’ basic information and samples will first be scrutinized in detail. These data and samples are an essential basis for risk assessment. When reviewing the primary data, attention will be paid to the manufacturer’s qualifications, reputation, historical performance, and other information. For example, the manufacturer’s production capacity, product quality, and compliance with local regulatory requirements are all critical indicators for assessment. At the same time, an in-depth investigation will also be conducted on the manufacturer’s credibility, including its contractual fulfillment status and the status of commercial disputes. This information can help determine whether the manufacturer can take risks.
Comprehensive tests will be conducted on the samples’ quality, safety, and efficacy. These tests include but are not limited to, biological tests, chemical tests, and so on. It will be based on the test results to determine whether the sample meets the requirements of local regulations and the risks it may face.
3.Sample inspection is an essential part of the cosmetic import process; according to the import of general cosmetics and imported cosmetics, the corresponding test must be carried out for particular purposes of the inspection time. The inspection time for available cosmetics is usually 5-10 working days, while the inspection time for special-purpose cosmetics is more extended and may take 15-30 working days. These timeframes may vary depending on product type, quantity, importing country, mode of transportation, etc.
During the sample inspection process, cosmetics must be thoroughly inspected for appearance, ingredients, labeling, packaging, and safety. These inspections require various instruments and methods, such as gas chromatography, high-performance liquid chromatography, ultraviolet-visible spectrophotometer, microbial detector, and so on, to ensure the product’s quality and safety.
4.Customs declaration information: Imported cosmetics must submit the following information when declaring customs. First, the imported non-special use cosmetics filing application form contains the basic information about the product, the use of the effect, and so on. It is an essential document in the process of customs clearance. Secondly, the product formula is also an important part, which describes in detail the composition and use of the product, for the quality and safety of the product have a vital role. In addition, the product quality standard is also one of the information to be provided; it is the guarantee and standardization of product quality to ensure that the quality and safety of the product are in line with the relevant national standards.
At the same time, the Chinese name of the product naming basis is also one of the information that must be provided; it is the product name of the norms and standards to ensure the accuracy and legitimacy of the product name. In addition, the product’s original packaging (including product labels) is also one of the information that must be provided. The norms and standards for product packaging ensure the accuracy and legitimacy of the product packaging. Suppose the proposed packaging is designed specifically for the Chinese market. In that case, it is necessary to provide product design packaging (including product labels), which is also the norm and standard for product packaging, to ensure its accuracy and legitimacy. Finally, it is also necessary to provide the content of ingredients, etc., which is the standardization of product ingredients to ensure their accuracy and legitimacy.
5.The State Drug Administration is essential in China’s drug regulatory system. When a company wants to introduce its cosmetic products into the Chinese market, they must be reviewed and approved by the SFDA. This process requires much information, including cosmetic formulations, manufacturing processes, quality standards, and testing data.
After submitting the information, companies must wait for the SFDA to review the information. This process may take some time, depending on the completeness and readability of the information. The review will take a relatively short time if the information is complete, precise, and compliant. Otherwise, it may take longer to wait for additional information or revisions.
The accreditation process includes a detailed analysis and evaluation of the information and possible interviews or on-site inspections. The NDA reviews all submitted data to determine the drug product’s safety, efficacy, and quality controllability. This process requires a high degree of specialized knowledge and skills and an in-depth understanding of regulatory statutes.
6.Querying the filing information is a common way to obtain information related to imported cosmetics. Through the filing number, we can inquire about all the information related to the cosmetic product, including the product name, manufacturer, importer, list of ingredients, expiration date, and import approvals.
For consumers, knowing detailed information about a product can help them better choose the right product for them. For example, people who are allergic to certain ingredients or have particular skin types can check the filing information to know the list of ingredients of the product so as to avoid purchasing products that are not suitable for them. In addition, consumers can also check the filing information to determine the authenticity of the products and avoid buying counterfeit or substandard products.
To facilitate consumers’ and regulators’ checking of the filing information, relevant regulatory authorities will provide online search platforms. These platforms usually provide a detailed search function, which allows users to make inquiries based on keywords such as filing number and product name. At the same time, these platforms will also provide detailed help documents and customer service support to help users better understand and use the query function.