SHFDA Meeting on Adverse Cosmetics Reaction Monitoring

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Event review

Attendee

Ø  Wang Xuemin (Vice President, Shanghai Skin Diseases & STD Hospital)

Ø  Zhao Yanjun ( Deputy Director, Institute of Shanghai Food and Drug Supervision)

Ø  15 company’s representatives including the following attendees registered with EUCCC

Agenda

Ø  Morning

1.       The adverse cosmetics reactionmonitoring (ACR)system

2.       The developments and related data in the first half of 2012

3.       Q & A

Ø  Afternoon

4． Content of the report

5． The categories and diagnostic criteria of ACR

Minutes

Morning Meeting：

1.       The Adverse Cosmetics Reaction Monitoring System.

1)      Definition of ACR

2)      Stakeholders

·         SFDA – the policy-maker on national level

·         National Cosmetic Adverse Reaction Monitoring Centre – in charge of national technical operation

·         Local FDAs

·         Provincial and Municipal Cosmetic Adverse Reaction Monitoring Centre – in charge of provincial technical operation (SH: Shanghai Dermatology Hospital (SHDH))

·         Monitoring Sites (SH: 17 district and county level hospitals)

·         Cosmetic Companies

·         Consumers’ Associations

3)      How to collect data and feedbacks

SH: 1 Monitoring Center + 17 Monitoring Sites (17 district and county level hospitals)

4)      Strengthen the communication between government and enterprises regarding the monitoring process and the efficient use of data

2.       The Developments and Related Data in the First Half of 2012

1)       Developments

·         The overall trial operation of the monitoring network runs well in Shanghai during the first-half of year. SHDH has offered technical training to sentinel hospitals regularly, and has published monthly reports and briefings. They also established a regular meeting mechanism to improve work systemically.

·         Problems encountered: 1.) Asymmetrical data collecting in SHDH and SHFDA; 2.) Integrity of the data information.

·         SH Work Plan: to accomplish the regulatory system construction in three years, ahead of schedule according to the 12^thFYP.

2)       Data Collected in SH

·         550 cases in total: 40 male, 510 female

·         By Age: 3-82 years old, highly concentrated between 20 to 59.

·         592 products of 203 brands involved

Table 1:

Table 2:

Table 3:

3.       Q & A

Opinions from the attendees:

·         Recording data in absolute terms is not scientific

COLIPA :Factor the sale volume in and use the case/sales ratio.

·         The definition of “consumer”: Invoice should be provided by the consumer.

·         It’s hard to determine the correlation between the adverse reaction and the products. Many dermatologists only indicate allergic reaction in the diagnoses without giving a proper allergen test.

Authorities:

hope that all companies can clarify the main ingredients in the report form, to help government identify high-risk allergens. They stressed again that the objective was not to catch the “bad guy” but to supervise the allergen for the public health.

(Due to weather condition and the technical nature of meeting in the afternoon, EUCCC representative does not attend the afternoon session.)

Afternoon Training Session

1.       Content of the Report

·         Info of the consumer

·         Info of the product

·         Records of usage and description of the ACR

2.       Categories and Diagnositic Criteria ofACR

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