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

7

Source: APEC

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

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

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

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

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

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

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