IFPMA-TFDA Workshop on Couterfeit Medicines ‘Integrated Approach Against Fake Medicines’ Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines On 6th February 2015 At Taipei International Convention Center Taipei, Taiwan

1. APEC Roadmap to Promote Global Medical
Product Quality and Supply Chain Security
Mark Paxton, MS,JD
Office of Drug Security, Integrity, and Recalls
CDER/Office of Compliance
January 2015

2. 7
Source: APEC

3. APEC Roadmap to Promote Global Medical Product Quality
and Supply Chain Integrity (1)
• APEC LSIF and its subordinate organizations (e.g., RHSC) operate as
Private-Public Partnerships
• Within APEC, work generally addressing counterfeits is ongoing, but for
drugs, that work only addresses a subset of those that are
adulterated/misbranded and moving in international commerce.
• Across APEC, the goal is to ensure that our patients are receiving only those
products that our individual member economies authorize to be on their
market
• Clearly, globalization of drug industry creates significant challenges to
regulatory authorities acting alone.
• Requires much better understanding of each others’ rules covering product
development, raw material sourcing, manufacturing controls, and import and
export operations

4. APEC Roadmap to Promote Global Medical Product Quality
and Supply Chain Integrity (2)
• FDA proposed, and RHSC submitted to APEC a Multiyear Project Proposal
• It was proposed that funding comes from APEC (~$500,000), with in-kind
contributions from participating RHSC members (typically, in-kind
contributions).
• One goal for FDA was to overcome some of the political obstacles
associated with WHO and its prior and on-going efforts to address SSFFC
products moving in international commerce.
• Another goal was to ensure the APEC work had a global focus and could be
leveraged to support the current WHO Member State Mechanism

5. APEC Roadmap to Promote Global Medical Product Quality
and Supply Chain Integrity (3)
• Proposal was cleared across FDA, USG and all other APEC governments.
• Project was approved by APEC in 2012, and work commenced in January,
2013, with a firm completion date of no later than December 31, 2017.
• To date, only a small fraction of the overall APEC budget has been spent
(~$50,000) due to widespread support and financial contributions by
Member Economies and their constituent organizations.
• With an RHSC-nominated Oversight Committee, the following are the
primary objectives for each of ten (10) work streams:
 Gap Assessment (where applicable)
 Develop Capacity Building Tool-Kits
 Conduct Training (and measure effectiveness of training and Tool Kits)
 Draft a Strategic Plan/Roadmap, with recommendations, and submit to LSIF

6. Project Tracking Table following the 1st Stocktaking Meeting
•“X” denotes that an activity is completed or well underway
Work Stream Lead/FDA
Representative
Gap
Assessments
Draft Tool Kits Training Effective
ness
cGMPs (Audits
and Supply Chain
Controls)
EMA/Karen
Takahashi and
Rick Friedman
X
GDPs Abbvie/Karen
Rothschild and
Frank Perrella
X X X
GI/Eps
(Imports/Exports)
Takeda/Huascar
Batista X
Product
Identification,
Authentication
and Traceability
GS1/Connie
Jung X X
Detection
Technologies
China NIFDC/
Cindy Buhse and
Duane Satzger
N/A
Internet Sales Health Canada/
Katie Neckers
X
Single Point of
Contact Systems
EDQM/Mark
Paxton X X X
Clinical and Retail
Pharmacy
Practices
USP/Mark
Paxton X
Product Security RX-360/TJ
Christl and Mark
Paxton
N/A X X
Surveillance and
Monitoring
WHO/Leigh
Verbois N/A X X X

7. Work to Date
• Work Streams were provided with “Resource Kits” (Charters, Proposed record-
keeping charts to track meetings and outcomes, and asked to develop a draft
timeline, s.t. the overall project timeline). - 2013
• Conducted an initial Single Point of Contact session in Seoul, Korea (May, 2013)
• A number of surveys were developed and distributed via RHSC to APEC
regulators to better understand their regulatory models (e.g., Internet Sales) -
2014
• Conducted a large meeting at SOM II, Qingdao, China (May, 2014) entitled: 1st
Stocktaking Activity of the APEC Roadmap to Promote Global Medical Product
Quality and Supply Chain Security
 Purpose was to solicit input from all APEC regulatory authorities and constituent organizations on the
current and future activities of each of the Work Streams
 Small, redundant break-out sessions were utilized to ensure robust participation
 Outcomes were recorded and fed back into the Work Streams
• Conducted Training on WHO Surveillance and Monitoring System (SSFFC Products)
and trained representatives from across APEC and ASEAN

8. Going Forward
• Continue regular, periodic meetings of the Oversight Committee
• Work Streams are in the process of completing relevant Gap Assessments
and Developing Tool Kits (Documents, Presentations, etc.) for use in
Training Materials
• First substantial training sessions will occur Jan.26-29, 2015 during SOM I in
Angeles City, Philippines (Product Protection, GDP and SPOC Network)
• Second set of training sessions are planned to occur in August, 2015 during
SOM III in Cebu, Philippines (GMP, Detection Technologies, GI/EP, Internet
Sales and Product Authentication)
• Final Training Sessions will occur in 2016 during SOM I/III in Peru
• All training sessions are video taped and will be professionally edited and
included in the Tool Kits
• Draft Roadmap Development will Begin in 2015 – expected early completion

9. Thank you!
Mark Paxton
Office of Drug Security, Integrity, and Recalls
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
mark.paxton@fda.hhs.gov