Decoding China's Marketing Authorization Holder (MAH) System

The webinar was successfully concluded on

March 06, 2024

Topics Covered:

Introduction to the Chinese MAH System.
MAH Legislative History.
Administration Structure.
Overview of MAH Responsibilities.
Marketing Authorization Application.
Pharmaceutical Product Import.
Pharmaceutical Product Distribution.
Agent of Overseas MAH.
The Challenges & Benefits of Appointing MAH Agent in China.
Tips for Navigating the MAH Agent Landscape in China.
Q&A Session.

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Jane has over seventeen (17+) years of experience in new drug R&D and more than twenty (20+) years in Regulatory Affairs (RA). She possesses a deep understanding of NMPA and global regulations, including FDA, EU, and ICH. Her strong scientific background, extensive knowledge, and previous role as a CDE reviewer contribute to her comprehensive understanding and interpretation of these regulations.

Presented By

Jane Zhang

Sr. Director Regulatory Affairs, Freyr China

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Consumers

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Decoding China's Marketing Authorization Holder (MAH) System