The drug regulatory authorities in Guangdong, Beijing, Jiangsu and other places have successively announced that the summary of the efficacy claims of the old products and the supplementary recording of the filing materials have been postponed until the end of the year, and the conditions of the person in charge of quality and safety have been relaxed. As soon as the news came out, many people in the industry sighed: "I can really breathe a sigh of relief."

These places have extended the time limit.

On May 1, it was the deadline for the supplementary summary and product information of the old product to submit the efficacy claim basis. However, considering the current epidemic situation, the Shanghai Food and Drug Administration requested the State Food and Drug Administration to extend the time limit, and the State Food and Drug Administration sent a reply on April 27, agreeing to appropriately relax, in principle, it should not exceed December 31, 2022. As a result, the time limit for Shanghai enterprises was extended by 8 months.

Following the announcement by the Shanghai Food and Drug Administration yesterday, Guangdong, Beijing, Jiangsu, and Chongqing Food and Drug Administration also issued separate documents today to further refine the requirements for the extended period. All mentioned that if the company cannot complete the work before May 1 due to the impact of the epidemic, it should submit a written statement to the local market supervision bureau and attach corresponding supporting materials, and complete it within 3 months after the impact of the epidemic is eliminated. beyond December 31, 2022.

According to the submission instructions and certification materials submitted by the local drug administrations, the extension can be applied for, and the industry generally believes that "the regulatory authorities need to explain what certification materials are required". The relevant person in charge of a cosmetic registration and filing service agency told Qingyan, "The specific documents depend on whether the Food and Drug Administration has issued a supporting template, but in many cases, companies are prepared according to the actual situation, and then modified according to the review opinions of the Food and Drug Administration."

At the same time, the Guangdong Food and Drug Administration also reminded enterprises that the cosmetics filing person and the domestic responsible person should conduct self-inspection and sorting of the filed products under their names in a timely manner, and the filing products that no longer carry out the evaluation of corresponding efficacy claims should be changed or cancelled in a timely manner.

The Beijing Food and Drug Administration mentioned that if the company fails to complete the supplementary report within the extension period, it will be ordered to make corrections within a time limit. If the supplementary record is completed as required within the time limit ordered to correct, the production and import can continue. If the relevant product is no longer produced or imported, and the relevant filing person does not plan to fill in the supplementary report, it should take the initiative to apply for the cancellation of the filing product within the correction period, and the listed product can be sold until the end of the shelf life.

It should be noted that the summary of efficacy claims is aimed at cosmetics that have been registered or filed between May 1, 2021 and December 31, 2021. Supplementary product information refers to submitting the product implementation standards and product label samples of the historical products on the original registration and filing platform, filling in the product formula of domestic ordinary cosmetics, and uploading the label pictures of the sales packaging of special cosmetics.

In addition, the epidemic situation in Shanghai is the most serious. Therefore, in addition to the summary of efficacy claims and product information, the Shanghai Food and Drug Administration has also relaxed the extension of the validity period of the special cosmetics registration certificate, the extension and change of the cosmetics production license, and the handling of personnel health certificates.

A game of chess across the country

In response to the reply letter from the State Food and Drug Administration to the Shanghai Bureau on April 27, many people in the industry understood that it was only applicable to the Shanghai area, so they suggested national unification. Policy of Guangdong Province" "Is the same treatment in Guangdong Province?".

As a major cosmetics province in China, Guangdong has more than 3,000 cosmetics licensed enterprises, occupying half of the country. The postponement all confirms that under the situation of generally facing the challenge of the epidemic, the whole country is bound to be a game of chess.

It is worth mentioning that Qi Liubin, deputy director of the Cosmetics Supervision and Administration Department of the State Food and Drug Administration, also publicly stated a few days ago, "I am actively researching, sorting out, analyzing, seeking truth from facts, and proposing corresponding coping strategies according to the development of the situation, and jointly overcome with the industry. Times are tough."

In addition, on April 27, the State Food and Drug Administration also issued a reply letter on the issue of the person in charge of cosmetic quality and safety. request".

Regarding the issue of the person in charge of quality and safety, the Guangdong Food and Drug Administration and the Beijing Food and Drug Administration also, in accordance with the content of the above-mentioned reply letter of the State Food and Drug Administration, made it clear that the person in charge of cosmetic quality and safety shall, on the premise of possessing relevant professional knowledge of cosmetic quality and safety, Experience in the production or quality management of drugs, medical devices, and special foods can be regarded as experience in the production or quality and safety management of cosmetics. This fully shows that it is also an industry-wide matter to untie the person in charge of quality and safety.

According to the latest interpretation of the State Food and Drug Administration, special food refers to health food, formula food for special medical purposes, and infant formula food.

Under the guidance of the State Food and Drug Administration, Shanghai, Guangdong, Beijing, Jiangsu and other places have successively expressed their positions, so that the industry can see the country's determination to adapt to the situation and help enterprises to steadily overcome the bottleneck period of policy implementation. In response to the above postponement adjustment, many people in the industry said that "it is timely rain" and "the Supervision Bureau has done another real thing." However, the heads of several factories in Guangdong also told Qingyan that the supplementary records of the old products have basically been completed.

It can be seen that although the new regulations and the epidemic have eliminated a number of enterprises, creating a more standardized and healthy cosmetics market is the common yearning and pursuit of the industry, and cosmetics people will not easily lie down.

Source: Blue Eyes