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    The 11th China Pesticide High-Level Forum was held with great solemnity, during which experts from the Institute of Pesticide Testing provided detailed answers to various production and business-related issues.

    Release Date:

    2018-09-07

    On September 5, the 11th China Agrochemical High-Level Forum, hosted by the China Pesticide Development and Application Association, was solemnly held in Xinxiang City, Henan Province. During the event, more than 400 participants—including former Vice Minister of Agriculture Liu Jian, President of the China Pesticide Development and Application Association Liu Yongquan, Zou Qingpeng, a member of the Party Leadership Group and Deputy Director of the Henan Provincial Department of Agriculture, as well as other leaders, experts, and representatives from agrochemical companies—gathered to discuss topics such as developments in pesticide regulatory policies, green plant protection, agricultural product quality and safety, corporate environmental protection, and workplace safety. On the 6th, the policy dialogue session of the 11th China Agrochemical High-Level Forum was held as scheduled. The Ministry of Agriculture and Rural Affairs’ Pesticide Registration…

    On September 5,由中国 Pesticide The 11th China, hosted by the Development and Application Association Pesticide The high-level forum was solemnly held in Xinxiang City, Henan Province. During the conference, former Vice Minister of Agriculture Liu Jian and China… Pesticide Leaders and experts, including Liu Yongquan, President of the Association for Development and Application, and Zou Qingpeng, Member of the Party Leadership Group and Deputy Director-General of the Henan Provincial Department of Agriculture, as well as… Pesticide More than 400 people, including corporate representatives, gathered together, surrounding… Pesticide Discussions were held on topics including progress in management policies, green plant protection, agricultural product quality and safety, corporate environmental protection, and workplace safety.

     
     
    On the 6th, the 11th China… Pesticide The high-level forum’s policy dialogue session was held as scheduled. Ministry of Agriculture and Rural Affairs Pesticide Deputy Director Shan Weili of the Testing Institute, Director Wu Houbin of the International Exchange and Services Division, Director Liu Shaoren of the Supervision Division, Deputy Director Fu Guijun of the Pharmaceutical Administration Division, and other officials provided detailed responses to various questions raised by the attendees regarding production licensing, registration, product labeling, and other matters.
     
    The following is a brief transcript of on-site Q&A on several key issues; for detailed information, please refer to the official audio recording. To obtain the recording, please contact agropages@163.vip.com.
     
     
    When applying for a production license based on the dosage‑form standard, should the application be submitted in accordance with GBT or the Appendix? If neither standard includes the dosage form being declared, what supporting documentation is required?
    There are two perspectives to consider: first, what type of dosage‑form registration certificate is held; second, how to approach grassroots law enforcement nationwide. As long as the registration certificate and the manufacturing license are consistent, that suffices. When applying for the production of a specific dosage form, the registration certificate takes precedence. GBT is a voluntary standard; during submission, only the registration certificate needs to be taken into account—national standards are not required.
     
    If the formulation ratio of a compounded product falls outside the three ratios specified in the registration certificate, what additional documentation is required when submitting the registration application?
    A plan is already in place, but no final conclusions have been reached yet. Relevant regulations will be issued subsequently.
     
    A brand-new creation Pesticide , apply for new Pesticide Can trials conducted prior to registration approval be used for registration purposes?
    Not recognized.
     
    Creation Pesticide The product has been registered overseas and is currently undergoing clinical trials in China. Are there any specific policies governing its export?
    Efforts are underway to ensure the prompt promulgation of relevant regulations.
     
    The group comprises two independent companies: one manufactures active pharmaceutical ingredients (APIs), while the other procures APIs from the former. The procurement is not for external sales but solely for internal use, effectively constituting an internal material flow. Given that the products bear no external sales labels, does this comply with the relevant requirements?
    The two independent companies are legally equal and shall independently fulfill their legal obligations. All sales activities must be conducted in full compliance with applicable laws and regulations.
     
    Industrial biocides are all classified as pesticides. Upon import, it was discovered that… Pesticide Registration requirements do not apply to industrial biocides. In practice, numerous challenges arise. How should this be addressed from a regulatory perspective?
    If a product is deemed to have non-agricultural uses, the Drug Administration may issue a certificate to authorize its release. As in many cases this year, mosquito-repellent wristbands were ultimately determined to be… Pesticide Purpose, shall be in accordance with Pesticide Carry out imports.
     
    When submitting product registration dossiers, there may be no qualified testing facilities available to conduct required studies, such as those on resistance or residue. How should this be handled at the time of submission? And if, after submission, relevant authorities issue corresponding findings, are there any applicable procedures in place?
    In such cases, the Ministry of Agriculture may designate an appropriate entity to carry out the task. By engaging in proactive communication and submitting a written request accompanied by relevant explanations, the Ministry can designate a qualified or authoritative organization to undertake the work.
     
    It is difficult to identify suitable trial sites for horticultural studies, and there is growing demand for improved pesticide use in this sector. Could the scope of accreditation for horticultural trial sites be expanded, and could relevant policies be introduced?
    At present, companies clearly perceive a shortage of available testing laboratories. This reflects a transitional phase under the new certification policy. Twenty-six new testing laboratories will be announced shortly.
     
    The existing product was submitted at the time without undergoing environmental testing. Do we need to provide environmental documentation for the current expansion?
    Submit in accordance with the new regulations. Requirements have been tightened; if, following supplementary document review, the risk is deemed unacceptable, the application will not be approved.
     
    Pesticide Registration of trial filings. Trial schedules often involve various contingencies, such as changes to the testing institution or extensions of the trial period. However, the filed information does not always align with the actual circumstances. Requirements for trial registration vary across provinces. Could greater flexibility be introduced, for example, allowing mid‑trial modifications to the submitted information?
    Filing is not an administrative license; it is a matter‑of‑fact notification. Accordingly, it does not constitute an administrative penalty. If there are any changes, simply submit a new declaration.
     
    The warranty period is two years. However, the actual product has been demonstrated to perform reliably for up to three years. Despite this, the application was not approved. On what scientific evidence is the decision not to grant a three-year warranty based? Could consideration be given to extending the warranty period further?
    For first-time applications, if the documentation demonstrates eligibility for a three-year period, approval will be granted. For applications seeking to extend a two-year term to three years, due to considerations related to data collection, the original two-year duration will remain unchanged.
     
    Relocating a business—from land acquisition to design and planning—can take several months. Regulations stipulate that no production licenses will be issued after August 1, 2019, and applications must be submitted two months in advance. Time is extremely tight. If a company lacks production capacity by August 1, will the Ministry of Agriculture adopt a blanket policy and refuse to issue any further production licenses, or are there alternative solutions?
    The industrial park must be a Level‑4 or higher industrial park. For relocating enterprises, prior to completing the relocation, they must ensure that at least one facility remains operational at the original site. Pesticide The production license is valid as long as it remains within its period of validity.
     
    A certain patented product of the company is selling well in Linyi, Shandong. The 1‑kilogram bulk package is divided into 10 transparent small bags for portioning. However, the local agricultural authorities issued a fine, citing a discrepancy between the inner and outer packaging. Is this justified?
    The outer packaging must clearly label the contents. It is necessary to promptly communicate with the local competent authorities and may file an administrative reconsideration.
     
    Change to registered suspension seed coating agent seed When handling suspending agents, which category applies after renewal of registration? Which category should be followed when applying for a production license? And if, during enforcement, the documentation does not match, how should this be addressed?
    Previously registered products will remain unchanged, and after renewal they will still be suspension‑type seed coatings. The newly added considerations are in accordance with… seed Handling of suspending agent standards. The production license shall be applied for under the same formulation name as indicated on the registration certificate.
     
    At present, bundled products are quite popular. Are there any specific regulations governing the external packaging of such products?
    The Ministry of Agriculture is closely monitoring this issue and is currently gathering information for analysis. Until new policies are issued, several red lines must be maintained: each individually packaged product and its label must comply with the relevant regulations; and products manufactured by the same company should be reasonably explainable.
     
    When other companies entrust this company with processing, which enterprise prints the QR code? If the QR code is printed on behalf of the commissioning party, does the commissioning party also upload the relevant information?
    Ownership of the product vests in the Client. Product management is the Client’s responsibility.
     
    Is there a transitional period between the new and the old production licenses? After the new label is approved, can the original label continue to be used while it remains within its validity period?
    Old product labels remain valid for use within their period of validity.
     
    Pesticide When an enterprise establishes a new plant site in another location and operates as an independent legal entity, what standards should it follow when applying for a license?
    Treated in accordance with the standards for newly established enterprises.
     
    Can a manufacturing enterprise entrust a research institute and another enterprise to produce a small batch of samples for registration purposes?
    Products submitted for registration shall be at least at the pilot‑scale stage, and the applicant shall be responsible for their authenticity. The law does not specify the identity of the manufacturing entity.
     
    Chemistry Pesticide Can insecticides and fungicides be mixed?
    In principle, they should not be mixed.
     
    Must agrochemical‑fertilizer products be registered according to three tiers?
    Agrochemical‑fertilizer products can be registered and treated as fertilizer additives; the key consideration is… Pesticide Ingredients.
     
    Can plant growth regulators be registered as ternary mixed formulations?
    Sure.
     
    New Pesticide The registration trial permit has been approved. May efficacy trials for other crops be conducted within the validity period of the permit?
    New Pesticide Registration trials for active ingredients and formulated products are approved separately. If it is a new… Pesticide The formulation’s certificate covers all five aspects—efficacy, toxicology, environmental impact, and residue—and applications for trials on other crops are eligible.
     
    How should bio-stimulant products developed overseas be classified for registration in China?
    You need to look at the product’s origin. If it’s chemical, then according to chemistry… Pesticide Apply according to the relevant standards. If it is a biological product, file under categories such as plants, microorganisms, biochemistry, or fermentation.
     
     
    Source: AgroPages World Pesticide Network

     

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