How to comment VICH guidelines Shixin XU, PhD, Prof. China IVDC

2 I.History II.Achievements III. Comments procedures

3 I. VICH History of participating

4 China participating VICH history July 2010 the first participating the 4 th VICH Conference in Paris, France, 3 people participated. Reported by Animal Pharm, IFAH Europe sent a thanking letter. Nov participating the VICH meeting in Tokyo, Japan Jun participating the 1 st VICH outreach forum meeting in Brussels, Belgium Feb participating the 2 nd VICH outreach forum meeting in Washington D.C., USA Nov participating the 3 rd VICH outreach forum meeting in Auckland, NZ, Deputy Director of VB, MOA participated Jun participating the 4 th VICH Public Conference in Brussels, Belgium

5 China’s contribution to VICH ’ June 2010First presentation on the 4 th VICH Conference in Paris Feb 2013 Proposed to establish the guidelines for the Efficacy Studies for the combination products. February 2013 Report the progress of Drafting the Concept Paper on the guidelines for the combination products in the 2 nd VICH Outreach Forum meeting in Auckland, New Zealand, SC decided to established Task Force for the Efficacy Studies for Combination Products, China was appointed as the member of the Task Force by SC. June 2014 Appointed as reporter of group discussion in the 4 th Outreach Forum meetings in Brussels, Belgium.

6 II. VICH Achievements

7 By participating the VICH forum meeting and the mutual communication between Sino-US seminar, China regulatory authority now more likely to take more consideration on the official and draft guidelines developed by VICH when making our guidelines to minimise the use of test animals and costs of product development for the sake of animal welfare to accept multilaterally agreed guidelines for studies to ensure product quality, safety and efficacy as well as to protect public health, animal health and welfare and the environment

8 Achievements- cont’ more willing to listen to the comments of Veterinary Medicinal Products industries within the country and foreign industry create a basis to allow the industry and regulatory authority dealing with new, emerging issues and relevant science more actively to share information with others through VICH Public Conferences

9 Introduce VICH into China All official guidelines were translating into Chinese with our IVDC. Several guidelines are transforming into China’s GL and be implemented: Bioequivalence TAS GCP

10 III. VICH Comment procedure

11 Step 9 Recommendation for review Step 1  Concept paper to propose issue  Review by SC  Appointment of Topic Leader/Chairman Step 2 EWG to produce draft Guideline Step 3 SC to approve draft Guideline for consultation Step 4 Public consultation in the regions Step 5 EWG to review comments and finalise Guideline Step 6 SC to adopt final Guideline Step 7-8 Implementation of Guideline9 step procedure Development of a VICH Guideline: The 9 step procedure

12 Comment Procedures When the VICH GL goes for public comments, there is a letter from Focal Point of VMP to our IVDC. Then we organised to translate into Chinese and distribute it to 10 experts who are familiar with the scientific area and ask them feed back comments within 10 working days after search for bibiliography. We collect the comments together and discuss in detail to compare amongst VICH, FDA, EMA and our own (if there is) GLs, to find out any pivotal comments. Then we translate the collected comments into English and check if there is any typing error in the GL(sometimes there is), and then send back to Focal Point as the national comments. The Focal Point will in charge to send the national comments to VICH secretariat.

13 Comment in majority Scientific base, always is our focus of care Difference amongst VICH, FDA, EMA and our own GLs design procotol requirement animal facility statistical Difference in framstructure always exist Language a bit of human resources

14 Some wishes Facilitate and accelerate to develop the GL for vaccines and herb medicines. Take more concern from the developing country’s profits, because those countries are rarely R&D new molecular entity, mostly are combination products, so wishes to develop more guidelines suitable for the development of combination products. Uptake some experts from the developing country to join either EWG or TF so allow to make contribution.

15 Thank you for your attention!