China NMPA Extends the Submission Deadline of Certain Cosmetic Documents due to COVID-19 Lockdown

Background

As per China’s new cosmetic regulations, May 1, 2022 is the deadline for cosmetic companies to complete the document supplementation of previously registered and notified cosmetics and the submission of the summary of product efficacy claim basis. Products failing to supplement documents as required before that date shall not continue to be produced and imported until the supplementation is completed. For products failing to upload the summary of efficacy claim basis within the time limit, the medical products administration departments will order the company to make corrections, give a warning, and impose a fine. Under severe circumstances, the company will be suspended from production and operation, and the main person in charge will be fined.

Items	Products	Documents to be Supplemented
Documents supplementation	Cosmetics registered or notified on the previous registration and notification platform	Executive standard; Label sample manuscript; Formula (for Chinese domestic general cosmetics); Label picture of sales packaging (for special cosmetics).
Documents supplementation	Cosmetics registered or notified before May 1, 2021	Product classification code
Submission of the summary of efficacy claim basis	Cosmetics registered or notified from May 1, 2021 to December 31, 2021	Summary of efficacy claim basis

Table 1 Documents that should have been supplemented by May 1, 2022

However, the implementation of the above work has been affected by the lockdowns or restrictions due to the COVID-19 resurgence in several areas, including Shanghai. Many cosmetic companies are unable to submit the required documents to comply with the regulatory requirements.

NMPA’s Temporary Policy

In view of this, China National Medical Products Administration (NMPA) issued a notice on April 27, 2022, approving Shanghai Municipal MPA's request to relax the requirements for cosmetic registration and notification documents and postpone the submission of certain documents during the COVID-19 lockdown. ¹ Specifically,

For cosmetic registration and notification documents that cannot be affixed with seals by registrants or notifiers, and other originals of supporting documents that cannot be provided temporarily, the relevant photocopies or electronic copies can be accepted first, and the originals of relevant documents can be supplemented as required after this wave of COVID comeback ends.
The time limit for supplementing certain cosmetic registration and notification documents (see Table 1) and uploading the summary of product efficacy claim basis in Shanghai will be extended from May 1, 2022, to December 31, 2022.

Provincial MPAs’ Responses

After Shanghai was allowed to delay the document submission deadline by eight months, the MPA of Guangdong, Jiangsu, and Zhejiang provinces, as well as Beijing and Chongqing municipalities, which have also been affected by the pandemic, adopted similar postponement measures on April 29. So far, there are more than 10 MPAs have joined the rank.

Regions	Measures for failing to supplement the documents and submit the summary of efficacy claim basis before May 1, 2022
Guangdong Province	Cosmetic notifiers or domestic responsible persons (RPs) are allowed to submit a written statement to their local medical products regulatory authorities to apply for a delay in submitting the summary of efficacy claim basis and supplementing notification dossiers. Notably, the corresponding work shall be completed within three months after this wave of COVID-19 comeback ends and no later than December 31, 2022, in principle. *Among them, Beijing requires that corresponding supporting materials should also be attached in addition to the written statement.
Jiangsu Province
Beijing Municipality
Chongqing Municipality
Zhejiang Province	For document supplementation, the deadline has been extended to August 31, 2022. If it is indeed impossible to complete the supplementation before August 31 because of the pandemic, a description of the situation should be submitted to the Provincial Drugs and Cosmetics Evaluation Center. The corresponding work shall be completed in time after this wave of COVID comeback ends and no later than December 31, 2022, in principle. For submission of the summary of efficacy claim basis, cosmetic notifiers or RPs are allowed to complete it in time after this wave of COVID-19 comeback ends and no later than December 31, 2022, in principle.

Table 2: Postponement measures in some COVID-affected regions in China

Industry Comments

These policies reflect regulatory authorities' understanding of the difficulties with the registration and notification work amid the pandemic rather than a signal of loosening of policies.
Cosmetic notifiers and RPs should check and sort out their notified products as soon as possible to ensure that the relevant submission work is completed in time. If previously notified cosmetics are no longer produced or imported, they should voluntarily apply for notification cancellation through the new notification platform. If the cosmetic notifiers and RPs have not obtained the user account of the new platform, a written application shall be submitted to the municipal medical products administration department to apply for notification cancellation.