Access to the boom market

knoell in China

Located in Shanghai on China's central coast.
A perfect base to support global portfolios!

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knoell China

Dr. Knoell Consult Shanghai Co. Ltd

Dr. Knoell Consult Shanghai Co., Ltd is a wholly-owned subsidiary in China of knoell group. It was established in 2010 and consists of a young, dynamic, and professional team. We focus on local regulations and provide consultancy services for local product registrations, while also assisting domestic companies in achieving product registrations on a global scale.

 
Dr. Knoell Consult Shanghai Co. Ltd
Room 805, Tower B, Central Towers | No. 567 Langao Road | Putuo, Shanghai 200333
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Bo Yang
Managing Director knoell Shanghai
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Chemicals

China's industrial chemicals are governed by two regulatory systems. The Ministry of Ecology and Environment of the People's Republic of China (MEE) oversees new chemicals and released the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12). For the product safety of hazardous chemicals, the Measures for Administration of Hazardous Chemicals Registration was released by the Ministry of Emergency Management (MEM) according to the ‘Regulations on the Control over Safety of Hazardous Chemicals (Decree No.591) for management of hazardous chemicals.

At knoell we have experience to provide you comprehensive and tailor-made service to support you through all the registration processes, especially for inventory check, local agent, development of compliance strategy, monitoring of studies, dossier preparation and post-submission tracking. Also we can provide service on product safety & stewardship, including but not limited to safety data sheets (SDS), labels, GHS, dangerous goods, volatile organic compounds (VOC).

Complete knoell service portfolio on Chemicals.

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Chemicals

Biocides

In China, biocides are mainly regulated by the following authorities and fall into multiple regulatory frameworks.

Hygienic disinfectants are overseen by National Health Commission (NHC) through the Measures for the Administration of Disinfection (NHC Order No. 27, 2020). Pesticides are regulated by the Institute for the Control of Agrochemicals, Ministry of Agriculture and Rural Affairs (ICAMA, MARA), following the Regulations on the Management of Pesticides (State Council Decree No. 677, 2017).

  • Veterinary disinfectants and some insecticides used on animals and animal living environment are subject to Regulations on the Management of Veterinary Drugs (State Council Decree No. 677, 2017), under the supervision of the Institute of the Veterinary Drug Control (IVDC) of MARA.

knoell has the experience to guide manufacturers, distributors, repackagers, and blenders at every stage in the biocide regulatory compliance process, including for daily consumer products and products related to drinking water. We offer support in pre-marketing strategy, compliance review, testing monitoring, data gap analysis, dossier preparation and submission in China.
For service of pesticides and veterinary disinfectants in China, please view here and here.

Complete knoell service portfolio on Biocides.
 

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Biocides

Crop Protection & Crop Nutrition

In China, the pesticide is regulated by “Regulations on the management of pesticides” released by the State Council Decree in 2017 (latest revised on March 29th 2022). The authority is the Ministry of Agriculture and Rural Affairs of the P. R. of China (MOARA, previously known as the Ministry of Agriculture, MOA). The pesticide need to be registered when you want to manufacture or operate (including import, export and sale) it in china according to MOA Order [2017] No. 3 “Measures on the management of pesticide registration”.
In China, the fertilizer is regulated by “Measures on the management of fertilizer registration” released by MOA in 2000 (latest revised in 2022). The authority is also the MOARA. knoell China can support registration and compliance consulting for a wide range of agricultural products, including biopesticides, conventional pesticides, fertilizers, biostimulants, etc. 
Complete knoell service portfolio on Crop Protection and Crop Nutrition!

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Crop Protection & Crop Nutrition

Food and Food Contact Materials 

In China, The Food Safety Law is the basic and supreme law of food safety. The pre-market approval is regulated by National Health Committee (NHC) and China National Center for Food Safety Risk Assessment (CFSA), together with the management system of a positive list.
knoell local regulatory experts follow closely on domestic regulation trends and updates, and provides cross-border support for our clients, from inventory check, study management and monitoring against local test guidelines (e.g. migration test), dossier preparation, Declaration of Compliance (DoC) and liaising with the competent authorities.

Complete knoell service portfolio on Food and Food Contact Materials.

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FOOD AND FOOD CONTACT MATERIALS

Animal Health

In China, the regulatory oversight for veterinary drugs is carried out by the Institute of Veterinary Drug Control, Ministry of Agriculture and Rural Affairs (IVDC, MARA), in accordance with the Regulations on the Management of Veterinary Drugs (State Council Decree No. 677, 2017). Feed and feed additives are directly regulated by MARA through a positive catalogue management system, following the Regulations on the Management of Feed and Feed Additives (State Council Decree No. 609, 2011). 

knoell has experience to provide you comprehensive and tailor-made service to support you through all the registration processes, especially for formulation review, compliance of quality system, pre-submission, monitoring of necessary toxicity studies and clinical/ confirmatory clinical trials during the pre-marketing stage. Complete knoell service portfolio on Animal Health.

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Animal Health

Human Pharma - DMF

In China, DMF (Drug Master File) registration system for active pharmaceutical ingredients (APIs), excipients and pharmaceutical packaging materials has been in place by the authority National Medical Products Administration (NMPA) since 2017, through the publication of the Adjustment on the Review and Approval issues for APIs, excipients and packaging materials (CFDA (former NMPA) Order No. 146, 2017). NMPA has established its own set of guidelines for DMF registration with specific data requirements that differ from those of Europe and the United States.

knoell has experience to support in regulatory research, compliance review, data evaluation and gap analysis, test monitoring for the tests according to the Chinese Pharmacopoeia (ChP) 2020 or the mandatory packaging material standards (YBB), as well as preparation of pharmacology and toxicology literature reviews, dossier preparation, submission and technical supports on expert review stage.

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Human Pharma

Cosmetics

In China, the National Medical Products Administration (NMPA) oversees the regulation of cosmetics and cosmetic ingredients in accordance with the Cosmetic Supervision and Administration (State Council Decree[2020] No. 727). Additionally, if the cosmetic ingredients are new chemicals, they fall under the regulation of the Ministry of Ecology and Environment of the P. R. China (MEE) as part of the Industrial Chemical sector in China.

knoell has the experience to provide you with comprehensive and customized services to support you through the new cosmetic ingredients registration processes, especially for inventory checks, local agent support, compliance strategy development, toxicological and function claim studies monitoring, safety risk assessment, dossier preparation, and post-submission tracking.

knoell can also help you comply with the safety information reporting requirements for existing cosmetic ingredients, which is a special requirement set by the NMPA. 

Complete knoell service portfolio on Cosmetic.

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Cosmetics
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YOUR ACCESS TO THE ASIAN MARKET

We support you in the entire regulatory process to gain and to maintain marketability of your chemicals in Asia.
Learn more

Access to the Asian market

Events & conferences in China

spalten3
MEET US AT BOOTH #A6Z031
in person in Xiamen, Fujian, China

China Feed Industry Expo

MEET US AT BOOTH #A6Z031
18 - 20 Apr 2024
More information on
Animal Health
MEET US AT BOOTH #A25

China Replas

21 - 22 Mar 2024
in person in Xiamen, Fujian, China

China Replas

MEET US AT BOOTH #A25
21 - 22 Mar 2024
More information on
Food Contact Materials
in person in Shanghai, China

24th CHINA INTERNATIONAL AGROCHEMICAL & CROP PROTECTION EXHIBITION

MEET US AT BOOTH #81F212
13 - 15 Mar 2024
More information on
Crop Protection

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WeChat ID: knoellSH