Multi-Year Project: August Monitoring Report
Please submit through your APEC Secretariat Program Director by Aug. 1 of each year.
Please note that this report will be used to determine your next year’s funding.
SECTION A: Project profile
Project number & title: / M CTI 04/12TAPEC Project to Promote Medical Product Integrity and Supply Chain SecurityTime period covered in report: / 01 January 2014- 31 December 2014 / Date submitted: / 01 August 2014
Committee / Working Group / Fora: / Committee on Trade and Investment/Life Science Innovation Forum/Regulatory Harmonization Steering Committee
Project Overseer Name /
Organization / Economy: / Mark Paxton/Food and Drug Administration/United States
SECTION B: Project update
Briefly answer each of the questions below. Section B should be a maximum of 4-5 pages. Focus on progress made since your last report, or since the project started.
Current status of project:
On schedule: YES
On budget: YES, but year-to-year rollovers are occurring because:
A) The US Government shutdown in November, 2013 forced the Roadmap to delay expending 2013 funds for a planned Training Session on Good Distribution Practices in the 2013 Host Economy, and
B) The Roadmap received substantial, additional, but unexpected, funding made from the member economies and the WHO during 2014 which greatly mitigated direct Roadmap expenditures in 2014.
Currently, as has been approved by the Regulatory Harmonization Steering Committee, the plan is to fund most, if not all expenditures for training sessions on the periphery of SOM I and SOM III during CY 2015 and CY 2016. The first of these expenditures will occur January 26-29, 2015 in the Philippines.
On target to meet project objectives: YES
If NO, provide details: How far is the project off schedule, budget or objectives? What corrective actions are being taken to resolve any problems? What support is needed from your Committee or the Secretariat in addressing these problems?
Not Applicable (N/A)
Continuing relevance: Does the project remain a high priority for both the involved fora and the broader APEC agenda? How is this relevance verified? If NO, what are the reasons for reduced relevance and/or priority and should the scope of the project be amended?
Yes, this project is still a high priority as evidenced by the broad participation by representatives of the private and government sectors across APEC, and as recommended by the LSIF. In addition, this Roadmap’s visibility has extended beyond LSIF and is now viewed widely across the CTI, including agricultural components with whom a pilot project covering track-and-trace standards is likely to be launched in 2015, along with unanimous support from the APEC Business Advisory Council (ABAC) and the Global Data Standards sub-group of the CTI.
Implementation: Describe progress and any deviations against the project’s work plan. How have stakeholders and other fora been engaged during the implementation stage?
As of this writing, nine (9) work groups have been established under the Roadmap with participation across the globe represented by subject matter experts from governments, the private sector and academia. Each work group is in varying degrees of completion of gap analyses and toolkit training development depending on the complexity of the area. Work plans have been submitted by most of the work groups. Others are just getting started (e.g., Detection Technologies). Additionally, it is possible that during the final quarter of 2014, one other work group covering product protection will be formed and led by RX-360, an international supply chain association of manufacturers and wholesalers. Specific
The Single Point of Contact (SPOC) Work Group has fully disseminated its tool kit (along with the Public Awareness tool kit) and both are ready for training programs that will begin in the 1st Quarter of 2015. Similarly, the GDP and GMP work groups have completed their gap analyses and are planning to have new training materials (i.e., tool kit) disseminated soon, followed by training programs in the 1st Quarter of 2015 as well.
At the same time, the Internet Sales work group has disseminated its survey instrument, and the Import/Export Practices work group is ready to disseminate its survey instrument. In both cases, analyses and reports of the surveys will be completed by 1Q, 2015 and ready for dialog. Similarly, the Clinical and Retail Pharmacy Practices work group will be ready to discuss its survey instrument by then. In addition, the Track-and-Trace work group will be at the tail end of the design of a pilot project by 1Q, 2015, and the Detection Technologies work group will be kicking off its first meeting at that time.
With so much occurring between the end of this reporting cycle (August, 2014) and 1Q 2015, combined with the success of the Qingdao meeting, Roadmap participants are planning to have a large meeting on the periphery of the SOM I and SOM III meetings in the Philippines, as requested by the RHSC Chairperson. This will be reflected in the amendments to the budget.
Challenges: If not covered in Q1, describe any problems which have arisen (or might arise) and how you overcame them / aim to overcome them. How might these change the project schedule or budget? How might your fora, Committee or the Secretariat help?
The only significant challenge experienced since the last annual report came as a direct consequence of the US Government’s shutdown in October, 2013. That event disrupted implementation of a large meeting covering Good Distribution Practices that was planned for November, 2013. This was overcome, at least in part, by integrating all of the work group efforts into the May, 2014 1st Stocktaking Meeting of the APEC Roadmap to Promote Medical Product Quality and Supply Chain Security (“1st Stocktaking Meeting”) conducted at the 2nd Senior Officials Meeting in Qingdao, China, in May, 2014.
Objectives and outputs: How do the results of the project so far (if any) compare with its expected results? Are outputs being delivered on time and of sufficient quality? Are the right stakeholders or participants being engaged? (You may refer to section C, as applicable.)
All of the project expectations are being met, or exceeded in terms of quality of output, and quantity and quality of participation. In fact, there is a very high degree of meaningful information being transferred among all of the participants, both north-south and equally important, south-north. See APPENDIX 1 for High-Level Outcomes from the SOM II Meeting in Qingdao, China.
Monitoring and evaluation: Describe any monitoring and evaluation activities undertaken or started during the previous year. How was the information collected? Describe any results or findings, if not covered in Q5. What are some of the key lessons learned during implementation?
Evaluation of the 1st Stocktaking Meeting in Qingdao during SOM II was conducted and the results were excellent overall. Work group participants had the opportunity to engage across other work groups to better understand how their work was being developed as a part of the larger Roadmap. Additionally, participants had the opportunity to better understand by observing first hand, the overall efforts of APEC and how the Roadmap work is parts and parcel of a larger initiative within APEC.
SECTION C: Participant and output information
Participant information: Please provide details, where applicable, of participants in any events or studies carried out over the past year. Insert rows or tables as needed.
Please refer to APPENDIX 2 for the list of participants in the Oversight Committee.
Event / Activity: / List of Participants in the Oversight Committee and Chartered Work GroupsTotal # / # male / # female / Details
54 / 27 / 27 / Oversight Committee Members
Comment on the composition of the participants: in terms of economies, fora, gender mix, background, skill-sets, etc. Do you feel the right people are participating, and in the right ways?
All of the participants (oversight committee and work group participants) are subject matter experts as they relate to the development, production, commercialization, security and protection of legitimate products and have demonstrated knowledge and awareness of the issues surrounding the international trade of SSFFC medical products. Across the nine (9) existing workgroups, most of the APEC economies are represented, as well as a large number of non-APEC economies and a similar large number of international organizations (e.g., academia, WHO, USP, EDQM, etc.).
Outputs: Please provide details, where applicable, on any outputs from the past year (e.g. # workshops, publications, websites, CD sets, etc.). Change headings or insert rows as needed.
Type of output / # planned / # actual / Details1st Stocktaking Meeting (Qingdao, China) / 1 / 1 / A large meeting of all the work groups at the SOM II meeting in Qingdao, China, served to generate outcomes from numerous, detailed discussions from APEC economies and their invited participants.
SECTION D: Budget
Attach the updated MYP budget template with a breakdown of APEC-provided budget to date, including:
Actual expenditures vs. planned costs (using most recently approved budget figures). See Appendix 3.
Variance notes: An explanation of any budget line under- or over-spent by 20% or more.
Proposed budget for the coming year (2015): ~$382,000
For approval by APEC
SECTION E: Appendices or additions
You have the option of attaching any of the following. This information will help us better understand and support your project, support overseers of similar projects and plan for future projects.
❑ Lists of the project’s participants, experts or consultants, with job titles and contact info
❑ Event agendas
❑ Links to any relevant websites or online material (e.g., reports, resources created)
❑ Results of participant feedback or other project evaluation (raw and/or analyzed)
❑ Any other relevant information or resources that would help us learn more about your project
FOR APEC SECRETARIAT USE ONLY APEC comments: Is the project management effective? How could it be improved? Are APEC guidelines being followed? Is the project still relevant to APEC and fora priorities?APPENDIX 1
Summary of Breakout Discussions
Manufacturing Practices
1. What is within scope of the GMP workgroup?
Best practices in relation to identified and relevant GMP requirements, whether elaborated in GMP guidance itself, industry best practices or related regulatory best practices.
Some consideration to be given to inspection capacity development or training of inspectors/regulators although this might be practically addressed through existing platforms e.g. WHO, PIC/S. It will be important to ensure consistency in training regardless as to whoever delivers it.
2. There is consensus that manufacturers of drug substances and drug products must be under the supervision of the national authorities in the country where they are located regardless as to the destination of the products they manufacture. This should impact supplier selection, outsourcing decisions and marketing authorization applications and review. This is because the use of foreign DRAs (e.g., USA and EU) in monitoring manufacturer’s activities is not sustainable. Thus, compliance with domestic regulatory requirements should be a threshold requirement.
3. Only a small number of countries publish databases of authorized manufacturers (EU, Canada, China). This would be considered a best regulatory practice and should be encouraged.
Databases would also be useful for product registrations, audits and inspections.
4. Some existing best practices were shared with respect to verification of receipt through the approved supply chain e.g. serialization of C of As, electronic transfer of documents pre-shipment.
5. Product release processes. Where product unintentionally fails to meet the requirements for the originally intended market/client it may be diverted to a less demanding market. The latter market/client is at risk nevertheless of receiving substandard product.
The difficulty to implement change that requires regulatory approval (e.g. product and process improvements) in a global market contributes to different requirements for different markets for the same product and contributes to the problem of diversion of potentially substandard product to certain markets.
6. The reverse of supplier qualification is as equally relevant to supply chain security i.e. what is the nature of your customer?
7. Shadow factories:
❑ Supply is from a different site than the one qualified and under regulatory oversight
❑ Product is made using contract givers, materials, processes, equipment and sold independently as the original product or marketed as a competitor.
8. Issues surrounding re-packaging and relabeling should be explored by the Working Group.
9. Best practices for supplier audit should be collected to ensure their scope goes beyond traditional GMP but takes a broader view of potential risks to product quality such as some of the supply chain security/product integrity issues that are subject to the Roadmap project. Current vendor qualification is simply not adequate to ensure that only legitimate products reach patients.
10. It could be useful to collect information from APEC national authorities on their general approach to inspection of local manufacturers and manufacturers outside of their territories.
DATA BASE OF INSPECTIONAL PRACTICES WOULD BE VERY USEFUL TO INDUSTRY AND REGULATORS ALIKE.
Single Point of Contact Systems (SPOCS)
❑ There are a very limited number of formal SPOCs currently existing in APEC economies, and most of the global experience with SPOCs has been in Europe. There are formal SPOCs in Singapore and Indonesia, and possibly China. There are informal SPOCs in the United States and Canada. One advantage to a formal SPOC is that the primary points of contact are identified. In the Philippines, the main point of contact for SSFFC medicines is the police; in other APEC economies the primary point of contact is the Ministry of Health or the competent drug regulatory authority.
❑ Data development and maintaining up to date information in regard to SSFFC medicines is a concern since there is a lack of data. Most data currently collected is related to seizures and arrests and better data collection is important. There was discussion that there are difficult to collect data without a common definition. However, the surveillance and monitoring program should ameliorate this if SPOCs report into the Roadmap Surveillance and Monitoring system.
❑ There was discussion about industry involvement and the role industry can play in analyzing suspected SSFFC medicines. There was agreement that industry should be engaged, and it was noted that many multi-national pharmacy companies have security units and covert security measures associated with the products.