In order to strengthen the quality supervision of imported drugs, China has started the inspection of overseas enterprises producing imported drugs since 2011, and by 2017, it has carried out the production quality inspection of 131 varieties of imported drugs. The 2017 drug inspection report shall be made public by the National Drug Administration of China (CNDA) on June 8, 2018.The serious defects found in the overseas inspection in the report mainly manifested as the inconsistent production process, major changes are not reported to China timely; the inauthenticity of the registration application information; the production facilities, equipment and production operations were not able to effectively reduce the risk of product contamination or confusion, the inability to effectively control unqualified products and so on.

In order to further strengthen the understanding of the overseas drug manufacturing enterprises about our country’s drug regulatory policy and the requirements of related technologies, strengthen the risk communication of overseas inspection, enhance the consciousness of drug marketing authorization holder and overseas drug manufacturing enterprises to obey Chinese pharmaceutical laws and regulations, promote the enterprise support and cooperate degree on the inspection, China Center for Food and Drug International Exchange and the former Center for Food and Drug Inspection of CFDA jointly hold the inspection communication meeting of overseas pharmaceutical enterprises under the support and guidance of the former Office of Drug and Cosmetics supervision of CFDA, and the meeting agenda attached. The relevant matters are hereby notified as follows:

1. Conference organization agency

Guidance: Former Office of Drug and Cosmetics supervision of CFDA

Sponsor: China Center forFood and Drug International Exchange

Former Center for Food and Drug Inspection of CFDA

2. Time and Address

Time: Aug. 23, 2018 to Aug. 24, 2018

Address: Beijing Xinyuan Hotel (No. 6 Shifang Yuan Haidian District Beijing, Tel:010-63901166 )

3. Fee Scale

Registration fee: ￥300 per person (including meeting fee, document fee and lunch)

4. Method of Sign Up

Those who wish to participate in the meeting can sign up online at the relevant entrance of the website of the China Center for Food and Drug International Exchange or scan the following QR Code. Please fill in the relevant information accurately. The deadline for application is August 20.

The website address of China Center for Food and Drug International Exchange: http://www.ccfdie.org/ .

QR Code:

Sign up and send the meeting registration fee to the following account:

Account Name: China Center for Food and Drug International Exchange

Bank: Industrial and Commercial Bank of China Beijing Road Branch

Account Number: 0200025509006763272

Please specify when remittance: the inspection communication meeting of overseas pharmaceutical enterprises, the remitter’s company name and remitter’s name.

5. Contact Information

Institution: China Center for Food and Drug International Exchange

Address: Room 1106 Building 2 Fenglan International Center No. 32 Xizhimen North Street Beijing China.

Zip Code: 100082

Contact: Wang Rui Phone: 010-82212866 to 6037

Fax: 010-82212857 E-mail: wangrui@ccfdie.org.cn

Appendix: The agenda of inspection communication meeting of overseas pharmaceutical enterprises.docx

China Center for Food and Drug International Exchange

July 5, 2018