Advocacy Success Following Challenges Arising From COVID-19

A sudden wave of Omicron outbreaks in March 2022 seriously affected cosmetics companies’ progress in adapting to new regulations on registration and notification, making it impossible for many to complete the necessary paperwork by the official 1^st May 2022 deadline. Considering the huge impact of the COVID-related lockdowns on normal business operations, the European Chamber Cosmetics Working Group actively communicated industry feedback and submitted proposals to the National Medical Products Administration (NMPA). As a result, on 27^th April, the Department of General Affairs of the NMPA issued a response letter, allowing for ‘vacancy management’ to be adopted. Local MPAs, including Shanghai’s and Beijing’s, released announcements with more details on implementation. This advocacy success ensured that the cosmetics industry ccould implement the new regulations smoothly and avoid compliance risks.

Background

During March and April 2022, as cosmetics enterprises were trying to comply with new regulations on registration and notification that required supplementary documentation for previously registered and notified cosmetics, and the submission of product efficacy claim basis summaries, by 1^st May 2022, a sudden wave of Omicron outbreaks seriously affected progress in several aspects:

• Due to strict COVID containment measures in Beijing and Shanghai, most member companies’ employees were obliged to work from home, which led to great challenges in preparing the required stamped or authorised official documents as well as hindering team collaboration on the official registration and notification system.
• Submissions of essential materials for registration and notification were impeded or delayed due to logistical and product customs clearance disruptions. For example, the product samples required for the submission of additional information for special cosmetics often did not arrive—either on time or, in some cases, at all—which led to an inability to provide pictures of real product packaging and other related sample material.
• Product inspection and efficacy claims tests, as well as related notification and review, that needed to be submitted as a result of the new regulations were delayed because the responsible laboratory experts and officials were assigned to temporary COVID containment work.

Cosmetics Working Group’s advocacy efforts

To help members address these challenges and implement the new requirements smoothly, the European Chamber’s Cosmetics Working Group actively collected concerns from members in order to send industry feedback and submit proposals to the NMPA, and participated in a meeting to discuss these issues.

On 23^rd March, the Cosmetics Working Group provided feedback on several urgent issues to the NMPA, including suggestions related to the raw material safety information submission, and issues encountered when completing the supplementary documentation for previously registered and notified cosmetics.

On 22^nd April, the Cosmetics Working Group chairs attended a meeting with the Cosmetics Department of the NMPA, along with representatives of local MPAs and associations, to discuss issues the industry is facing, in particular those arising from the COVID situation.

On 25^th April, the Cosmetics Working Group submitted an advocacy letter to the NMPA, suggesting the acceptance of electronic documents for product registration and postponing the deadline to submit additional information for products.

Results

In response to the industry concerns, on 27^th April, the Department of General Affairs of the NMPA issued a Response Letter to the Request about Issues regarding Cosmetic Registration and Notification Management during COVID Prevention and Control (Shanghai Municipal Medical Product Administration Cosmetics Division [2022] No.107), allowing “vacancy management” to be adopted. This means copies or electronic versions of relevant documentation can be submitted first, and the original materials submitted when circumstances allow. The measure also extended the deadline—by eight months—for submissions of supplementary information and efficacy claims summaries.

Accordingly, the Shanghai Municipal MPA issued an Announcement on Cosmetics Registration/Notification and Production-related Matters during the City’s Pandemic Prevention and Control, which provided more details on implementation of this initiative.

This advocacy success ensures that the cosmetics industry can implement the new regulations smoothly and avoid compliance risks. The Cosmetics Working Group appreciates the quick response from the NMPA on the industry’s concerns, showcasing the results of the NMPA’s Fangguanfu Reform efforts (streamlining the government, delegating power and improving government services).