International Regulatory Support:
China

West to China Liaison

TSG’s Dr. Hong Chen can act as a liaison for western companies doing business in China. Dr. Chen can meet with relevant MOA or NHFPC personnel on a company’s behalf, discuss registration and compliance issues, or arrange meetings between a company and the Chinese agencies. Dr. Chen can also assist western companies in their business interactions in China, including technical communication between companies, connecting with relevant Chinese companies, finding qualified Chinese registration agents, coordinating business relationships and visits, and establishing relations with industry trade associations.

 

Sourcing

For companies interested in sourcing materials from China, TSG can provide a broad spectrum of services to support these efforts for chemicals, dietary supplements, pharmaceuticals and food processing. At the beginning stages, TSG can help identify a bonafide Chinese company making the specific materials needed by our client. TSG performs manufacturing audits in China to ensure that the manufacturing process, equipment and QA control procedure are in line with international regulations, and that the product satisfies the specification requirements of our clients. Our consultants also help with U.S. import issues, contract language and general communication between companies, establishment registration and annual reporting to EPA, and

GMP/GLP

(Good Manufacturing Practice/Good Laboratory Practice) compliance in China.

Product Registration


Ministry of Agriculture:
The Ministry of Agriculture (MOA) regulates all agrochemicals, including fertilizers, that are registered and sold in China, as well as products manufactured in China and sold in other countries (such as with contract manufacturing). In order to proceed with a registration through MOA, applicable data and forms must be submitted in both English and Chinese, product samples must be tested for efficacy and toxicity in designated testing centers in China, and the application package must go through a registration review process conducted by The Institute for the Control of Agrochemicals, Ministry of Agriculture (ICAMA). ICAMA is an affiliated institution of MOA and specializes in pesticide registration and administration, including the regulation and review of pesticide products. The ICAMA review boards are composed of members from more than 10 Chinese government ministries and agencies.

TSG’s consultants provide comprehensive product registration support for agrochemicals, including application preparation and submission, support of Chinese agent with sample testing and data submission, assistance in communicating with ICAMA and registration review boards, and resolution of registration issues, such as translating original efficacy data into Chinese forms, Chinese lab testing issues, and summarizing EPA GLP data in Chinese and English. When advanced registration assistance is needed, such as for formulation questions, data reduction possibilities and lingering application problems, TSG’s Asia-Pacific Director,
Dr. Hong Chen, will directly work with ICAMA and MOA officials to help resolve the issues.

National Health and Family Planning Commission:
The National Health and Family Planning Commission (NHFPC) regulates all disinfectants and consumer products sold in China, including food additives, cosmetics and medical devices. Registering these products with NHFPC requires significantly more data than their agrochemical counterparts, including efficacy and toxicology studies, labels and safety data sheets (SDS), detailed manufacturing process description, product development history and rationale, product formulation calculation tables, detailed use dilutions methods, et cetera. NHFPC requires that all data be translated side-by-side when submitted, and not summarized, which can be an arduous task due to the amount and difficulty of translating the technical material into Chinese. In addition, NHFPC does its own product chemistry, efficacy and toxicology studies for disinfectants and hygiene products, even when a company has its own existing data that were generated under GLP.

TSG’s consultants provide a full array of services to assist with NHFPC registrations, including data and technical translations, label development and translation, and acting as a company representative, which includes working with the local Chinese agent on application preparation and submission, as well as communicating with NHFPC. TSG can also assist with various testing issues in a NHFPC designated laboratory, such as sample requirements, test protocols, issues with testing results, et cetera.

Label and SDS Translation

Translating product labels and SDSs from English to Chinese is not an easy task, and with product registration at stake, it is important that labels are translated accurately. In many cases it is advised to use scientific and/or technical experts who can properly translate the data or label information because literal translations of the English language may not always produce the accurate phrasing, and can even lead to incorrect instructions causing potential registration problems. For example, in the United States a typical labeling term for a commercial use product is “For Commercial Use Only,” meaning it is not for household use. The literal Chinese translation of “commercial use” comes out to be something that means “for retail use,” suggesting it should be sold to consumers. These sorts of problems that arise from incorrect translations often lead to a delay in the registration process or even denial of registration.

TSG’s
Dr. Hong Chen is a technical expert with significant experience in U.S. and Chinese pesticide and chemical regulation. She is a certified English/Chinese translator and interpreter, making her an invaluable resource for western companies trying to register and ensure that labels are compliant for their products in China.

Pre-Entry Market Intelligence

For companies interested in entering the Chinese market, gathering market intelligence before any decisions are made can be the difference between success and failure. If a company is looking to register and sell a product in China, TSG can provide a comprehensive market analysis of what similar, competitive products are being sold as well as determine the requirements, cost and timeline to register the product. TSG can also assist with the acquisition of a Chinese company, contracting to a Chinese company and exporting products to China.

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Dr. Hong Chen (Director), Dr. Bob Stewart (Vice President) and Mr. Chris Bruno (Marketing Manager) from TSG with CCCMPHIE delegation after traditional Chinese medicine seminar.Dr. Hong Chen (Director, Asia-Pacific Affairs), Dr. Bob Stewart (Senior Regulatory Consultant) and Mr. Chris Bruno (Marketing Manager) from TSG with CCCMPHIE delegation after traditional Chinese medicine seminar.
TSG at Tong Ren TangDr. Hong Chen (Director, Asia-Pacific Affairs) and Dr. Bob Stewart (Senior Regulatory Consultant) from TSG visit Beijing Tong Ren Tang supplement and Chinese medicine company.
TSG & MLA at AQSIQDr. Bob Stewart (Senior Regulatory Consultant) from TSG and Mr. John Conner (Partner) from McKenna, Long & Aldridge visit AQSIQ