RA Meeting minutes

Date , Time & Venue: 
1. RA meeting, 9:00 - 12:30, DAS office March 24, 2017;
2. Con-call and on-site meeting, 10:00 - 12:00, CLC office, March 31, 2017;
3. Con-call and on-site meeting, 9:30 - 16:00, BASF office, April 1, 2017.

Agenda:

-Anti-trust;

-Latest information on the new regulation and supporting rules;

-Discussion on 9 position papers and key issues;

-Discussion on the draft supporting rules;

-Any other business.

Objective:
1. To share the latest information on the new regulation and supporting rules;
2. To discuss the solutions for MAD and EUP issues;
3. To discuss the CLC strategy for the supporting rules and how to provide our comments and concerning;
4. To assign the leading company to study the concerns we found on draft supporting rules.

Minutes:

所有参会人员就以下事项达成一致意见：

All participants has reach to the consensus of the items below:

一、关于新条例的配套规章制度

Update on latest information on supporting rules for new regulation.

- 农业部已开始征求各部委意见，并要求 4 月 10 日前反馈；

- MoA has asked other ministries for the comments of supporting rules, and required the reply from the ministries as of April 10.

- 配套规章不会和新条例同步实施。由于配套规章各项程序进展缓慢，农业部可能无法按新条例实施时间完成配套规章，所以配套规章会晚于新条例实施。
- The supporting rules will come to be effective later than effective date of the new regulation.

二、关于对新条例配套规章制度提出建议的策略 

The strategy for commenting to the supporting rules.

- 不建议任何一个成员公司把问题上升到政治层面，不把简单问题复杂化，不把技术问题政治化。没有任何政策制定针对限制外企在中国发展，现在的情况是谈的难度大，但不是到了绝无可谈的程度。

- Strongly suggest that any member company DO NOT let the key issues arise to the politic level, DO NOT complicate and politicalize the issues. There is not any policy-designing to restrict the development of foreign enterprises, we do have the opportunities to discuss with the authorities;

- 原有对配套规章里问题研究的分工不变，对于配套规章出现的新问题会继续分配任务，各公司对问题的建议可直接反馈给牵头公司和联络人。对于所分配的任务不只要提出相关建议，每个公司还需要跟踪所提建议的接受程度并总结，如所提建议在正式发布配套规章最终稿上的接受程度，分析所接受建议是通过哪些办法实现的。分析建议未接受的原因及对所有公司产生的影响。
- For the new issues found in the draft supporting rules, we continue to assign the leading companies to study out, any other suggestions for the issues could be provided to the leading company and contact person directly.  The leading companies need to trace the acceptance in the final supporting rules for each suggestion, and conclude the approaches to success , also analyze the impacts to the industry from the unaccepted suggestions. 

- 各成员公司在工作安排上要有所准备，如果配套规章实施在 9 月 1 日或 10月 1 日，所有工作重点应围绕配套规章进行。

- Our RA staffs of member companies need to be ready to focus on the supporting rules before it is implemented.

- 意见反馈策略。

1、协会会在征求公众意见阶段前后组织通过各种渠道进行意见反馈；

2、成员公司可利用各种渠道表明我们所担心的问题，但要但不要违反上述的原则。

- Strategy for provide our feedback.
1. CLC will provide the suggestions to authorities through organizing various channel while the public commenting period;
2. The member companies should utilize own channel to express our concerning, but do not obey the principle above.

三、关注重点问题 Key concerned issues

MAD 问题 MAD issue

1、背景 Background

配套规章描述了部分登记试验“.......可以由与中国政府签署互认协定的遵从良好实验室规范的境外实验室出具”，据此规定会导致国外的试验数据将不会被认可。
The draft supporting rules will describe that "The applicant may provide the test report regarding to chemical toxicity and environmental effect of pesticides issued by oversees laboratories based on the GLP determined in bilateral or multilateral recognition agreements signed with Chinese government" To sign bilateral or multilateral recognition agreements between governments will be a long process, so in case GLP data could not be accepted by the authorities, the companies needed repeat relevant test in China and increase time and economic cost.

2、OUR position
- 新条例中关于登记试验条款中未表述需要和其他国家签署双边或多边协议.      
- The new regulation does not state that the test should be conducted in bilateral or multilateral recognition agreements signed with Chinese government 

3.OUR suggestions
- 支持双边多边互认，基于现实国情，建议在配套规章中加入“.......或农药登记评审委员会认可的 GLP 实验室” 或在配套规章中加入目前正在执行的《登记资料要求》中关于登记试验单位的描述“境外试验资料应当由农业部确认的机构出具........”。
- We encourage the govt. to sign bilateral or multilateral recognition agreements with other govt., but based on the situation of China, we suggest to make the revision in the draft supporting rules that could accept the data generated from the overseas labs under GLP.

- EUP 问题  EUP issue ( Highly related to the MAD issue)
1、背景 Background
- 根据配套规章的规定，可能产生“只有取得试验许可并启动后的试验才是有效的登记试验”的问题。会造成前期研发阶段所取得试验数据（如产品化学和毒理学试验等）不被认可。
- Assuming that the MAD would not be the issue, according to the contents of EUP which described in the draft supporting rules, there might generate the impact that the test conducted in R&D phase would be not accepted by authorities.( like chem, tox etc.)

- 配套规章的过渡期会设截止日期，目前预计为 1 年，如配套规章 2017 年10 月 1 日实施，截止日期有可能为 2018 年 10 月 1 日。目前问题是在截止日期后是否会接受截止日期前进行的试验？
- There might be a impact of administrating decision from authorities. The authorities will set up the deadline for the transition period when the supporting rules published, so the issue is that does the authorities will accept to receive the test conducted before the deadline?

2、观点 Our positions 

- 各成员公司的产品研发战略布局是基于长期农业部的政策，各类产品在新条例发布前就已布局，如果不接受截止日前所开展的试验资料，不仅会给企业的增加时间成本和投资成本，还会造成不必要的重复试验。
- Our member companies has set up the long-term strategy base on the policy of MoA, in case of not accept the data of test conducted before the policy deadline, there would widely increase the time and investment to the companies, and re-conduct the replicate tests.

3、建议 Our suggestions
- 希望农业部认可完全属于企业自主性研发阶段的试验，建议完善相关制度。
- Some tests were conducted in R&D phase, then generated data which will submit to authorities, like toxicity, chemical etc. We suggest that the MoA could improve the supporting rules to accept the tests conducted in R & D phase;

- 建议是农业部如果采取截止日期的做法，应接受在截止日期前开展的试验资料。
- In case of the MoA set up the deadline for the supporting rules, the MoA   should accept the data of test conducted before deadline.

四、关于配套规章制度草稿的讨论 Regarding to the discussion on the draft supporting rules
- 讨论 5 个新条例配套规章征求意见稿。对重点关注的《农药登记管理办法》《农药生产管理办法》《农药标签和说明书管理办法》逐条讨论和分配任务，具体内容请见附件；另， 《农药标签和说明书管理办法》由巴斯夫公司负责，《农药登记试验管理办法》由先正达负责。

- Assigned the new issues found in the key draft supporting rules, specific details as attached. 
BASF is responsible to study out draft "Administrative measurement for Labeling and specification on pesticide", Syngenta is responsible to study out draft " Administrative measurement for registration test on pesticide ".

五、其他内容 Others

- 中国农药发展应用协会将于 4 月 5 日召开小型座谈会，小范围征求企业对配套规章制度征求意见稿的意见。我们所有参会的成员公司应将讨论的重点意见在会上反馈。

- CAPDA plan to hold a meeting to collect the comments on the draft supporting rules internally, which are inviting our some member companies to join. So the participants of our member companies need to release our key comments on the meeting. 

- 关于与 ICAMA 高层会议

1. 高层会议时间确定在 4 月 28 日，地点暂定在药检所三楼会议室；
2. 考虑到药检所的会议室容量，需要限定人数。

- The meeting with leadership of ICAMA
1. The date of meeting is fixed on April 28, and meeting site is to the ICAMA. Other information would delivery when confirmed.
2. Need to limit the numbers of participant in consideration of the capacity of ICAMA's venue.

                                                                                         RA Committee, Croplife China
                                             2017 年 4 月 4 日