China Cosmetic Adverse Event Reporting Services from Cisema

China Cosmetic Adverse Event Reporting is crucial to maintaining compliance post-notification or post-registration of your cosmetics. To assist cosmetic manufacturers and operators (distributors, local authorized representatives) in post-market cosmetovigilance, the National Medical Products Administration (NMPA) has recently issued guidelines, on a trial basis, on how to report adverse events or /reactions.

To help you stay abreast of these latest regulatory changes and maintain compliance in China, our cosmetics RAQA team here at Cisema has developed the following services:

1. Regulation Translation and Summary
   • Detailed English translation of the “Guidelines for Collection and Reporting of Adverse Reactions of Cosmetics by Cosmetic Registrants and Filing Persons (Trial)”.
   • Key point summary highlighting critical aspects and compliance requirements
2. Compliance Assessment and Strategy Development
   • Evaluation of your current adverse event / reaction practices against the new guidelines.
   • Development of a tailored compliance strategy to meet NMPA requirements.
3. Adverse Event Reporting Solutions
   • Implementation of robust systems for the collection and reporting of adverse events / reactions including fully compliant templates
   • Training for your team on best practices for adverse reaction monitoring and reporting.
4. Adverse Event and Product Recall Simulation
   •  Identification of potential risks and adverse event types relevant to your cosmetics products.
   • Creation of realistic adverse event scenarios based on your product portfolio and market presence.
   • Advise on communication plans for informing affected parties
   • Take the role of regulators, consumers, and other external parties in collection, reporting and communication implementation exercises.
   • Evaluate the effectiveness of the simulation, with findings, CAPAs and recommendations.

Although the guidelines have been issued on a trial basis, it is expected that these will come into effect in the near future, therefore it is paramount that cosmetic manufacturers develop robust cosmetovigilance systems to avoid penalties such as having products detained at Chinese customs, mandatory product recalls or even product certifications revoked.

Our team of China Cosmetics RAQA experts can provide you with the guidance and support needed to navigate these new regulations confidently. By partnering with us, you can ensure that your products remain compliant.

Contact us if you are interested in our China Cosmetics Adverse Event Reporting Services or have any questions. We look forward to helping you achieve regulatory success and ongoing quality compliance.

Additional resources:

Read our article on China Cosmetic Adverse Event Reporting Guidelines (Trial) from May 24, 2024.

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