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Tuesday, November 15, 2022International

GMPs and Quality requirements in China (3/3)

BPF et exigences Qualité en Chine (3/3)

During the 5th RQC (Rencontres de la Qualité Cosmétiques), organised by IFIS and FEBEA, Victoria Caldy, Business Development & Marketing Director of Cisema (a consulting company specialised in regulatory affairs and quality in China), gave a complete overview of the new requirements that the new Chinese cosmetic regulation, the CSAR, has introduced in terms of GMPs (Good Manufacturing Practices), quality and safety of products. Troisième volet de son intervention avec le rapport annuel pour les cosmétiques généraux, les inspections BPF et le contrôle qualité au dédouanement. Third part of his intervention with the annual report for general cosmetics, GMPs inspections and quality control at customs clearance.

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The annual report for general cosmetics

From 1st January 2022, notifiers must provide an annual report between 1st January and 31 March, providing a summary of production and import for the previous calendar year.
This is not really a report in the strict sense of the word, but rather an online information entry, where you have to answer yes or no to a whole series of questions (worded in Chinese).

For any suspended production, the report should be updated, especially if it is due to quality problems or adverse reactions. It should also contain information on self-inspections.

To date, this annual reporting requirement does not apply to special cosmetics, as this information is part of the registration renewal dossier to be provided every five years.

Inspections and customs clearance

There are different types of inspections and controls in China:
• GMPs controls: a list of inspection points has been established and is already applied
• Sample inspections: guidelines for product controls taken by the authorities on Chinese territory are also available
• Controls carried out during customs clearance

GMPs inspection points

Even before the GMPs came into force on 1st July, the NMPA had already proposed, as early as April …

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