Analysis of Filing Management for First Import Non-Special Cosmetics through Shanghai Pudong

$ 20 $ 40 premium members free
Eliza Li
Monday , 13th Feb 2017
REACH24H Consulting Group China
Background

CFDA has announced a pilot implementation rule that from Mar.1st 2017 to Dec.21st 2018 the international companies can comply with filing management instead of registration when importing non-special cosmetics through Shanghai Pudong New District for the first time.

Following the announcement, CFDA released exact procedures to guide international companies how to file record with FDA.

During the webinar, the speaker will interpret the new filing procedures, compare the current and pending requirements, analyze the impacts on stakeholders and give advice to overseas companies.

Contents

1. Background

  • Development of filing regulation

  • Reason of choosing Pudong New Area

2. Understanding Filing Requirements

  • Applicable scope

  • Filing procedures

3. Comparison between current and pending requirements

  • Supervision method: pre-market VS post-market

  • Filing period: 4-6months to 3months

  • Filing dossiers: addition of GMP

  • Roles of stakeholders: responsible agent VS responsible person

4.  Impacts

  • Applicant

  • Responsible person

5. Practical advice

  • Risk existence

  • Product identification

  • Responsible person selection

  • Documentation preparation

  • Regulation changes tracking

  • Import time control

Speaker:

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Eliza Li  Cosmetic Regulatory Specialist

Eliza focuses on the research of China's cosmetic regulations and toxicology assessment. She has assisted many clients to obtain pre-market approval from CFDA and provided many professional consulting services on the finished products and new ingredients registration.