Rx-360 Asia Working Group Overview

Transcription

1 Rx-360 An International Pharmaceutical Supply Chain Consortium Rx-360 Asia Working Group Overview Presented by: Janice Berman Vice President, Quality Assurance Takeda Pharmaceuticals U.S.A., Inc. Protecting patients worldwide

2 Our opportunity Rx-360 has been recognized as a leader in developing supply chain security best practices, audits, and flash reports/communications by regulators and industry across US and Europe, with significantly less awareness and visibility in the Asia region. Increasing reliance on goods and services from the region. Due to the size and diversity of the Asia region, initially focusing on one major country, China, will help ensure success in this major market, and build a model for future expansion. 38

3 Why China? A major manufacturer and exporter,. Exports of Chinese pharmaceuticals continue to rise significantly China is a global leader for imported pharmaceutical ingredients, bulk drugs and APIs 39

4 Why China?,But also a major source of supply chain security and quality concerns; within China and through our industry 2014: Chinese police arrested 19 suspects for alleged sale of bogus medical devices originating from overseas waste, busting 13 marketing dens 2013: nine tons of raw materials for fake medicines seized by Chinese authorities 2012: contaminated gelatin capsules found to contain excessive levels chromium 2008: counterfeit heparin from China 2007: Chinese gangs selling counterfeit antimalarial drugs in Southeast Asia 40

5 Vision Rx-360 Asia Working Group will be a vibrant network of regional/global companies, protecting patient safety by sharing critical information, contributing to current Rx-360 work-stream outputs with information specific to this region, and influencing regional regulatory activities to improve the transparency and integrity of the supply channels to protect patient health regionally and globally. The group will partner with organizations in the region that share similar goals. 41

6 Getting off the Ground: Active Local Participation Initial meeting in November 2013 Subteamsformed Supply Chain Security Audits Membership Meetings held in China with international and local pharma/supplier participation 42

7 Asia Working Group Overall Goals Overall Goals: Create focused efforts in the region Identify emergent and current issues in China and share experiences/knowledge Liaise China work-streams with core work-streams Identify and plan educational and awareness building opportunities and platforms in the region Review White Papers/Tools and consider applications and/or needed additions from China perspective 43

8 Asia Working Group Overall Goals (continued): Build connections with industry groups and Chinese regulatory agencies/offices Facilitate and promote use of audit programs, to continue to improve transparency of supply channels Continue to build membership and participation in subteams 44

9 Asia Working Group Recent and future engagements Introduction to CFDA in March Presentation at APEC Meeting in April Presentation at CPhI Meeting in June NEXT OPEN MEETING Shanghai Astra Zeneca Offices Wednesday June 25 Contact Janice Berman at for more information 45

10 Questions My company buys drug products, APIs or regulated intermediates from China. 1. Yes, for more than 5 years 2. Yes, for less than 5 years 3. No 47

11 Question What are your company s major concerns regarding materials and products from China? 1. Counterfeits 2. Adulteration 3. GMP compliance 4. GDP compliance 5. All of the above 48

12 Questions What are the actions your company is taking on supply chain security in China? 1. Increased supply chain auditing 2. Increased on-site oversight 3. Supply chain mapping 4. All of the above 5. None 49

13 Questions What do you think Rx-360 should do in China on supply chain security? 1. Develop and share best practices, white papers 2. Workshops and conferences 3. Training courses and/or webinars 4. All of the above 50

14 Question My company buys drug products, APIs or regulated intermediates from India. 1. Yes, for more than 5 years 2. Yes, for less than 5 years 3. No 51

15 Questions How big is your team in supply chain security? Don t know 52

16 Contact Information See: Or: For More Information Or: Rx-360 Secretariat +1 (202)