22 – 23 April 2013, Beijing
ISPE
Topic
China
Regulatory and Compliance
Committee
Speaker :
Company:
22 – 23 April 2013, Beijing
Topic
ISPE China Regulatory
and Compliance
Committee
Speaker :
Company:
Vision and Mission
22 – 23 April 2013, Beijing
To become a widely recognized
social community in
Topic
bridging the gaps between regulators’ expectations and
industry practices through identifying common
regulatory issues, sharing better practices, and
promoting regulatory and technical harmonization in
China.
Speaker :
Company:
Objectives
22 – 23 April 2013, Beijing
1. Monitor changes/updates of all regulatory aspects in the pharmaceutical
industry in China and provide insight in global cGxPs changes in USA, EU,
Canada, Japan, Australia as well as other international organizations such as
WHO, ICH, PIC/S, etc., and share the information with the other ISPE
Committees and ISPE members in China.
2. Collaborate with other ISPE China committees to identify areas where
regulatory supports are needed and jointly propose solutions/practices in a
purpose to provide valuable information to the Chinese pharmaceutical
industry
3. Work, via CCPIE, as a liaison to the SFDA and/or provincial SFDAs to
provide supports to the industry and regulators in order to promote
Speaker :
innovative and generic drug development
and manufacturing in China
Company:
4. Serve the Chinese ISPE members by providing a platform that is intended
to share regulatory information and industry practices via a virtual
community/social media
Topic
Regulatory and Compliance
Committee 2013~2014 Achievement
22 – 23 April 2013, Beijing
• Conferences: Successful organize the 2013 & 2014 Spring and Fall
Conference;
• Successful organize the workshop with national drug safety
Supervision;
• Keep approaching different pFDAs for Joint workshop opportunity;
• Drug Administration Law revision;
Topic
– Draft the Appealing letter: GMP certificate combine with manufacture
certificate
• New Committee members recruited:
Wu: Yongfeng, Daniel Song, Xia
Speaker
Yun
Company:
• Continues provide Regulatory and GMP Inspection updates
• Launched on-line discussion group
Regulatory and Compliance
Committee 2015 Preliminary Plan
22 – 23 April 2013, Beijing
• Conferences
Topic
– Spring and Fall Conference;
– Joint section with CDPP in spring Conference;
• Organize three Sub-committees
– CMC & Registrations: focus on QbD implementation for innovative and
generic drug development in China.
– Quality & cGxPs: Quality Metric and GMP implementation
– Compliance & Practices: China & Global news
Speaker
:
• Drug Administration Law revision:
monitor
and participate
Company:
– GMP certificate combine with manufacture certificate
– CMO
Regulatory and Compliance
Committee 2015 Preliminary Plan
22 – 23 April 2013, Beijing
• New Guideline implementation: new TF or community for
new guideline published.
Topic
– E.g. biosimilar guideline implementation guidance
• Develop and deliver trainings and workshops with provincial
FDAs (Beijing, Shanghai, Shandong, Hebei, Jiangshu, Zhejiang,
Chongqing, Sichuan);
– E.g. QbD for generic drug development (CDPP support);
– US, EU GMP requirements; inspection training;
• Membership development
Speaker :
Company:
– Recruit more industry or regulatory experts by pFDA workshops;
– Involve more people join ISPE by different Task Force;