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United Nations Development ProgrammeCountry: Saudi Arabia
Project Document
Project Title: Support SFDA Second strategic plan implementation
SAU1O/82003Project ID:
Expected CPD Outcome #3: Sustainable Development Mainstreamed across the Economy
SFDA Capacity DevelopmentExpected Output(s):
Saudi Food and Drug AuthorityExecuting Entity:
Implementing Agencies: SFDA
Project SummarySFDA is the leading regional regulatory authority for food, drugs and medical devices with professionaland excellent services that contributes to the protection and advancement of the health in Saudi Arabia.In its continuing efforts to achieve its vision, SFDA recently developed its second strategic plan from2012 to 2016 which focuses mainly on building broad and deep capabilities, ensure thoroughness,transparency, and consistency in enforcement and communication, and complete the coverage of allrelevant areas. UNDP’s technical assistance in this project shall focus on the following outputs on thefollowing outputs; 1- Capacity development of SFDA; 2- Ensure thoroughness, transparency, andconsistency in enforcement and communication; 3- Complete the coverage of all relevant areas as perSFDA’s mandate; 4- Develop systems and processes to improve pro-activity in addressing emergingrisk
Programme Period: 2012—2016Total resources required US$ 17,759,492
Atlas Proposal ID: SAU1O!65588
Total allocated resources:Start date: 1sApnl 2012
0 Government $ US$ 17,759,492End Date 31st December2016
Previous unbudgeted SPAC Meeting Date 24th March 2012
Manaaement Arranoements NIM
Agreed by (SFDA):
Dr Mohammed AL Kanhal -
Executive President-
Agreed by ‘UNDP)/J / /
Kishan Khoday %./ //UNDP Resident Representative a
—_-- 7 /
United Nations Development ProgrammeCountry: Saudi Arabia
Project Document
Project Title: Support SFDA Second strategic plan implementation
SAU 10/82003Project ID:
Expected CPD Outcome #3: Sustainable Development Mainstreamed across the Economy
SFDA Capacity DevelopmentExpected Output(s):
Saudi Food and Drug AuthorityExecuting Entity:Implementing Agencies: SFDA
Project SummarySFDA is the leading regional regulatory authority for food, drugs and medical devices with professionaland excellent services that contributes to the protection and advancement of the health in Saudi Arabia.In its continuing efforts to achieve its vision, SFDA recently developed its second strategic plan from2012 to 2016 which focuses mainly on building broad and deep capabilities, ensure thoroughness,transparency, and consistency in enforcement and communication, and complete the coverage of allrelevant areas. UNDP’s technical assistance in this project shall focus on the following outputs on thefollowing outputs; 1- Capacity development of SFDA; 2- Ensure thoroughness, transparency, andconsistency in enforcement and communication; 3- Complete the coverage of all relevant areas as perSFDA’s mandate; 4- Develop systems and processes to improve pro-activity in addressing emergingrisk
Programme Period: 2012 —2016Total resources required US$ 17,759,492
Atlas Proposal ID: SAU1O/65588
Total allocated resources:Start date: lstApnl 2012o Government $ US$ 17,759,492
End Date 31st December 2016Previous unbudgeted S
PAC Meeting Date 24’ March 2012
IManaaement Arranaements NIM
Agreed by (SFDA):Dr. Mohammed AL Kan ha!
Executive President
Agreed by (UNDP):Kjshan KhodayUNDP Resident Representative a.i
BRIEF DESCRIPTION
Saudi Food & Drugs Authority (SFDA) completed the implementation of its first strategic plan (2007-2011).
Taking strategic planning as the planning approach to achieve its vision and mission, SFDA completed its
forward looking planning by developing its second strategic plan (2012-2016). SFDA has approached the
United Nations Development Programme (UNDP) to seek technical assistance and to jointly collaborate in
achieving its strategic goals set out in SFDA second strategic plan, based upon UNDP’s comparative and
competitive advantages in providing the required technical support.
in this context, the objective of this Project Document (PD) is to provide substantive support to SFDA,
through enabling SFDA to implement Food, Drugs and medical Devices strategic goals and initiatives laid
out in SFDA second strategic plan; as well as develop the required institutional capacity to discharge its
mandate and ultimately meet the national development plan’s aspiration to achieve its vision.
This joint project will benefit SFDA —in specific- in terms of institutional capacity development to support
SFDA in building broad and deep capabilities, help SFDA to ensure thoroughness, transparency, and
consistency in enforcement and communication, complete the coverage of all relevant areas as per SFDA’s
mandate, and finally develop systems and processes to improve pro-activity in addressing emerging risk.
This nationally executed project aims at providing advisory services, specialized experts, and administrative
support to SFDA. In the process, these activities will help in developing the authority’s policy, advocacy, and
executing capacity in the areas of food, drugs and medical devices.
II. SITUATION ANALYSIS
The 9tM National Development Plan (NDP; 2010-14) has the overall theme of sustaining the development
with a record $385 billion, 67% increase on 8’ NDP, targeted at improving standards of living, regional
development, economic diversification, knowledge-based economy and competitiveness, and human
resources including youth and woman. The NDP is based on the tenets of long-term strategy towards 2024
with the overarching target of having the kingdom as, “a developed, thriving and prosperous economy, built
on sustainable foundations’
As per the Ninth Development Plan, the plan envisages continued efforts to raise health standards for the
entire population, through expanding health facilities to cope with population growth, and improve
performance, quality of service and user satisfaction. The plan adopts a set of policies and programmes
directed towards furthering the role of cooperative health insurance to cover more segments of society;
achieving more decentralization in management and operation of health facilities; and supporting primary
healthcare facilities and their integration with secondary, specialist and referral care, and facilitating their
availability to the entire population in all regions.
SFDA developed its first strategic plan for the period from 2007 to 2011 with a vision “to be the leading
regional regulatory authority for food, drugs and medical devices with professional and excellent services
that contributes to the protection and advancement of the health in Saudi Arabia.” SFDA made some
distinguished achievements by implementing its first strategic plan. For the food sector, for example, one
main achievement is SFDA completed the inspection strategy on the borders of entry and also developed
the border inspection processes according to ISO 17020. An example of the Drug sector achievements is its
efforts to automate all drug and drug establishment processes using IT systems. Medical devices developed
the national register which contains a list of all medical devices and establishments which is the first to be
developed in Saudi Arabia.
In its continuing efforts to achieve its vision, SFDA recently developed its second strategic plan from 2012 to
2016 which focuses SFDA efforts on achieving high impact goals as set by its mandate. The second
strategic plan focuses mainly on building broad and deep capabihties. ensure thoroughness, transparency,
and consstency ri enforcement and communication, complete the coverage of all relevant areas as per
SFDAs mandate. and finally develop systems and processes to improve pro-activity in addressing emerging
risk.
III STRATEGY
The preliminary discussions between SFDA and UNDP focused on areas where UNDP could provide
substantive support in building SFDA capacity in implementing its second strategic plan. This project
document focuses on four major outcomes:
1 Support SFDA in building broad and deep capabilities, where UNDP competitive advantage in
building institutional capacity could support SFDA in enriching its expertise by attracting, retaining
and developing the appropriate human resources, enhance SFDA key internal tools and processes
to better support its mission, develop the required set of capabilities to take over key processes,
support Information Technology and Planning (ITP) and shared services sector in building their
capabilities
2. Support SFDA to ensure thoroughness, transparency, and consistency in enforcement and
communication, where UNDP competitive advantage in building institutional capacity could support
SFDA in Improving industry and consumer awareness and intra-agency cooperation through
interactive and coherent communication strategy, define internal control systems and institutionalize
accountability, align with relevant stakeholders on an efficient enforcement model
3. Support SFDA to Complete the coverage of all relevant areas as per SFDA’s mandate, where
UNDP competitive advantage in building institutional capacity could support SFDA in fulfilling
competencies and responsibilities outlined in mandate, also Optimize SFDA’s role regarding
inspection of local market food businesses and water bottling plants, build out pesticide standards
and related control infrastructure to cover the required scope as per SFDA’s pesticide mandate,
Implement effective processes to operationalize pesticide safety standards, reinforce safety of
drugs, bio-products, health, herbal and veterinary products across the value chain, pursue the
development of cosmetics standards and ensure the safety of cosmetics products, tighten SFDA’s
control over manufacturing , import and export of medical devices, and develop best practice
policies for specific / emerging product categories
4. Develop systems and processes to improve pro-activity in addressing emerging risk
Where UNDP competitive advantage in building institutional capacity could support SFDA in
establishing collaborative knowledge-sharing systems enabling early detection of potential hazards
to food and feed control system. fortify preparedness to emerging threats by discerning early on
market trends and emerging risks, and also Identify and swiftly act upon risks to patient safety
IV.
RE
SU
LT
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lan
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TOTA
L
V. MANAGEMENT ARRANGEMENTS
Execution ArrangementsThis project will be nationally executed through SFDA. SFDA will assume implementation
responsibilities with UNDP for recruitment of international and national advisors and other activities as noted
in the annual work plan. All project activities will be done through standard project board mechanism to
serve as a steering committee between SFDA and UNDP to ensure coherence of all activities under the
project. UNDP will provide technical support to all activities through the UNDP country office in Riyadh and
other reated resources as appropnate.
Project Board
The project board a the group responsbie for making on a consensus bas!s management decisions
for the project when guidance is required by the national project manager, including recommendation for
approval of project revisions.
Project reviews by this group are made on annual basis, or as necessary when raised by the national
project manager. The group is consulted by the national project manager for decisions, This group has two
roles, one for executive representing the project ownership to chair the group, and senior supplier role to
provide guidance regarding technical assistant to the project.
Project Organisation Structure
Project BoardSenior Beneficiaries Executi or Supplier
SFDA SFDA IJNDP
Project Assurance
Project assurance is the responsibility of each project board member, but the role can be delegated to
a staff within each organization. The project assurance role supports the project board by carrying out
objective and independent project oversight and monitoring functions, This role ensure appropriate project
management milestones are managed and completed. The Assistant Deputy Resident Representative
(ARR) UNDP Saudi Arabia will hold the project assurance role for the UNDP, and coordinator of SFDA
would undertake this role for SFDA. The national project manager and project assurance roles will never be
held by the same individual in SFDA.
National Project Manager
The national project manager will be appointed by SFDA and has the authority to run the project on a
day-to-day basis on behalf of the project board within the constraints laid down by the project board. The
national project manager is responsible for the day-to-day management and decision making for the project.
The project managers prime responsibility is to ensure that the project produces the results specified in the
project document, to the required standard of quality and within the specific constraints of time and cost. The
national project manager is appointed by SFDA through letter to UNDP. SFDA will also provide counterpart
staff, offices facilities and necessary office equipment (including computers) for project staff, and any other
project support facilities as deemed necessary.
Project Assistant
The project assistant will be appointed by SFDA with the responsibility to carry on the day- to- dayadministrative and financial project support.
Prior Obligations and Requisites
There are no prior Obligations and Requisites attached to this document
The schedule of Payments (USD) arid UNDP bank account details:
[ DATE AMOUNT (USD)
2012 $2,908,960
2013 1 $3,199,856
2014 $3,519,842
2015 $3,871,826
2016 $4,259,008
Total $17,759,492
1 The value of the payment, if made in a currency other than United States dollars, shall bedetermined by applying the United Nations operational rate of exchange in effect on the date ofpayment. Should there be a change in the United Nations operational rate of exchange prior tothe full utilization by the UNDP of the payment, the value of the balance of funds still held at thattime will be adjusted accordingly. If, in such a case, a loss in the value of the balance of funds isrecorded, UNDP shall inform the Government (SFDA) with a view to determining whether anyfurther financing could be provided by the Government (SFDA). Should such further financing notbe available, the assistance to be provided to the project may be reduced, suspended orterminated by UNDP.
2. The above schedule of payments takes into account the requirement that the paymentsshall be made in advance of the implementation of planned activities. It may be amended to beconsistent with the progress of project delivery.
3. UNDP shall receive and administer the payment in accordance with the regulations, rulesand directives of UNDP.
4. All financial accounts and statements shall be expressed in United States dollars.
5. If unforeseen increases in expenditures or commitments are expected or realized (whetherowing to inflationary factors, fluctuation in exchange rates or unforeseen contingencies), UNDPshall submit to the government on a timely basis a supplementary estimate showing the furtherfinancing that will be necessary. The Government (SFDA) shall use its best endeavours to obtainthe additional funds required.
6. If the payments referred above are not received in accordance with the payment schedule,or if the additional financing required in accordance with paragraph above is not forthcoming fromthe Government or other sources, the assistance to be provided to the project under thisAgreement may be reduced, suspended or terminated by UNDP.
7. Any interest income attributable to the contribution shall be credited to UNDP Account andshall be utilized in accordance with established UNDP procedures.
in accordance wtth the decismns and directives of UNDPs Executive Board:
The contribution shaH be charged:
(a) 5%1cost recovery for the provision of general management support iGMS) by UNDPheadquarters and country offices
8. Ownership of equipment, supplies and other properties financed from the contribution shallvest in UNDP. Matters relating to the transfer of ownership by UNDP shall be determined inaccordance with the relevant policies and procedures of UNDP.
9. The contribution shall be subject exclusively to the internal and external auditing proceduresprovided for in the financial regulations, rules and directives of UNDR”
VI. MONITORING FRAMEWORK AND EVALUATION
in accordance with UNDP programme and operations policies and procedures (POPP) outlined in the UNDP
user guide. the project will be monitored through the following:
within the annual cycle
on a quarterly basis, a quality assessment shall record progress towards the completion of key
resufts, based on quality criteria and methods captured in quality management table below,
• An issue log shall be activated in Atlas and updated by the project manager to facilitate tracking and
resolution of potential problems or requests for change
• Based on the initial risk analysis submitted (annex 1), a risk log shall be activated in Atlas and
regularly updated by reviewing the external environment that may affect the project implementation.
Based on the above information recorded in Atlas, a project progress report (PPR) shall be
submitted by the project manager to the project board through project assurance using the standard report
format available in the executive snapshot. Project lessons-learned log shall be activated and regularly
updated to ensure ongoing learning and adaptation within the organization, and to facilitate the preparation
of the lessons learned report at end of project.
Monitoring schedule plan shall be activated in Atlas and updated to track key management
actions/events
the annualccle
Annual review report. An annual review report shall be prepared by the project manager and
shared with the project board. As minimum requirement, the annual review report shall consist of the
Atlas standard format for the QPR covering the whole year with updated information for each above
element of QPR as well as a summary of results achieved against pre-defined annual targets at the
output level.
- Annual project review, Based on the above report, an annual project review shall be conducted
during the fourth quarter of the year or soon after, to assess the performance of the project and
appraise the annual work plan for the following year. In the last year. this review will be the final
assessment, This review is driven by the project board and may involve others as required. It shall
focus on the extent to whch progress is being made towards output, and that these rerr. a!n aligned
to appropriate outcomes.
Project Quarterly Progress Report (OPR) progress reports. Will be suDmitted by the National
Frolect Coordinator to Proiect Assurance and to the Outcome Board Such progress reports should
t: a cans ar ec s cs ea a “a son sn n o nsa
VII. QuALm’ MANAGEMENT FOR PROJECT AcTIvITY RESULTS
Replicate the table for each activity result of the A WP to provide information on monitoring actions based on
quality criteria. To be completed during the process “Defining a Project” if the information is available. This
table shall be further refined during the process “Initiating a Project”.
OUTPUT 1: Capacity of Institutional, indMdual and systems developed to serve processesand tools in all relevant sectors.
.
Activity Result 1 Ennch SEDA a expertise by attracting, retaining and developing the Start Date: 1 March 20112. appropriate human resources I
(Atlas Activity ID, j nd uate: 31 icc 2012
Purpose To Enrich SFDA ‘s expertise by attracting, retaining and developing the appropriate humanresources
Description Build SFDA capabilities to:
- Attract and retain best talent
-improve the expertise level of SFDA ‘s employees
- Conduct regular manpower planning studies as a basis for resource / budget allocation
-Ramp up expertise for scientists in biologics and emerging novel drug categories
-Ramp up expertise for inspectors in biologics and emerging novel drug categories
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?
been met?
Pre- and post- questionnaires or similar Questionnaires Annually
Expert feedback Expert Report Annually
OUTPUT 1: Capacity of Institutional, individual and systems developed to serve processesand tools in all relevant sectors.
Activity Result 2 Enhance SFDA key internal tools and processes to better support its Start Date: 1 March 201 12
(Atlas Activity ID)rnesion End Date: 31 Dec 2012
Purpose To Enhance SFDA key internal tools and processes to better support its mission
Description BuIo SFDA capabiities to:
- Es tablish integrated IT system throughout SFDA
- Achieve ISO accreditation for SFOA labs
- Support other departments to advance animal feed expertise and enhance control
- Integration of Feed Testing into Labs
-Streamline, calibrate and prioritize drug registration process
- Build up capacity / expertise of internal labs and contract private labs
- Ensure consistency and quality processes through SOPs and QMS
- Improve capabilities to monitor availability and security of drugs inside the KSA
- Improve evaluation and standard setting processes
- Euro and upgrade IT services n toe drug sector
- Launch Narcotics Druo System tNDS) and soclauze narcotics reaulations and qu:defines
- introduce a quality management system for the MD
OualttvCnte9a Qbauy Metrod - Date of Assessment
how/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?
been met?
Pre- and post- questionnaires or similar Questionnaires Annually
Expert feedback Expert Report Annually
OUTPUT 1: Capacity of Institutional, indMdual and systems developed to serve processesand tools in all relevant sectors.
Activity Result 3 Fully develop the required set of capabilities to take over key control Start Date: 1 July 20112(Atlas Activity ID)
processesEnd Date: 31 Dec 2012
Purpose To Fully develop the required set of capabilities to take over key control processes
Description Build SFDA capabilities to:
- Acquire the capabilities and resources to conduct controls
- Acquire the capabilities and resources to guide post-market inspections
- Acquire the capabilities and resources to conduct audits
Quality Criteria Quality Method Date of Assessmenthow’with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?
been met?
Pre- and post- questionnaires or similar Questionnaires Annually
Expert feedback Expert Report Annually
OUTPUT 1: Capacity of Institutional, individual and systems developed to serve processesand tools in all relevant sectors,
Activity Result 6 Support TP and shared serces n buidng their caoabllties Start Date 1 March 201 12(Atlas Activity ID) End Date 31 Dec 2012
Purpose To Sapoort TP and snared servces N Duild’rig ir capacht’es
Description Build SFDA capabilities to
-improve The expertise ieveí of SPDA empio} ees ‘n fTP ana Shared Services
Conduct egular manpov’er pianning stad,es as a cass tor resource budget ai’ocation N fTPanc Shared Services
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification what method will be When will the assessmentactivity result Nil’ be -nessured1 used to determine if quality criteria has of quality be performed°
been met7
[Pro-and post- quesonnaires or similar Quest,cnnaires Annually
Expert feedback Expert Report Annuai1y
OUTPUT 2: Communication strategy and control frameworks prepared and executed
Activity Result 1 mprove industry and consumer awareness and intra-agency Start Date: 1 March 20112
(Atlas Activity ID) eetbon through interactive and coherent communcahonEnd Date’ 31 Dec 2012
Purpose to Improve industry and consumer awareness and intra-agency cooperation through interactiveand coherent communication strategy
Description j Support SFDA to:
- Strengthen alliance with governmental ministries and agencies by ahaning on split of roles andresponsibilities
-Complete implementation of and full adherence to risk-based system across all departments
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification. what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?
been met?
Expert feedback Expert Report Annually
OUTPUT 2: Communication strategy and control frameworks prepared and executed
Activity Result 2 Define internal control systems and institutionalize accountability Start Date: 1 March 201 12
(Atlas Activity ID) End Date: 31 Dec 2012
Purpose To Define internal control systems and institutionalize accountability
Description Support SFDA to:
- Go live with all registration processes and licensing systems for local food manufacturers,warehouses, distribution centres, and relevant food products
- Go live with all registration processes and licensing systems, and clearance systems for allforeign food manufacturers,, importers, and relevant products
- Institutionalize quality management systems across food sector departments
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?
been met?
Expert feedback Expert Report Annually
OUTPUT 2: Communication strategy and control frameworks prepared and executed
Activity Result 3 1 Align wth relevant stakeholders an an etfcient enforcement model Start Date: 1 July 20112
(Atlas Activity ID) End Date: 31 Dec 2012
Purpose To A/ign with relevant stakenolders on an eff,cient enforcement model
Description Support SFDA to:
- Design and enforce an appropriate fee structure aiming at maximum cost recovery fromregistration and approval activities
- E acage in close parrnershrp with other aqencies to ensure ccns’stent enforcement ofstandards and candies
Quality Criteria Quality Method ‘ Date of Assessmenthow/with what indicators The uafirv of the Means of verification, what methcd wi/be Wnen will ne assessment-
‘ ,ron,, cc en. cc so cc ‘- ‘-e c,.a e — c e—
Expert feedback Expert Report
OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice
Activity Result 1 Continue to fulfill competencies and responsibilities outlined in mandate Start Date: 1 March 201 12
(Atlas Activity ID) End Date: 31 Dec 2012
Purpose To Continue to fulfill competencies and responsibilities outlined in mandate
Description Support SFDA to:
- Develop and rollout GCC Rapid Alert System for Food and Feed and implement recallthroughout KSA
-Establish private food lab registry database and licensing capability
- Establish export certification program
-Build laboratory for analysis and testing of pesticides
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result will be measured? used to determine if quality criteria has of quality be performed?
been met?
Expert feedback Expert Report Annually
OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice
Activity Result 2 Optimize SFDA’s role regarding inspection of local
(Atlas Activity ID)bunesses and water bottling plants
Purpose To Optimize SFDA role regarding inspection of local market food businesses and water bottlingplants
Description Support SFDA to:
- Fully transfer inspection of bottled drinking water and ice factories from MoMRA & MoC to SFDA
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?
been met?
Expert feedback Expert Report Annually
OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice
Activity Result 3 mplement eftectve processes to oerationalize pesticide safety Start Date: 1 March 201 12(Atlas Activity ID) standards
End Date: 31 Dec 2012
Purpose To lrnplement effective processes to operationalize pesticide safety standards
Description Support SFDA to:
- Develop, communicate and implement a streamlined process for registration / approval ofmaterials and products
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessmentactivity result sill be measured? used to determine if quality ciiteria has of quality be performed?
been met?
Expert feedback I Expert. Report Annually
__-
-
-
___-
- ---- - ___J_______-
OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice
Activity Result 4(Atlas Activity ID)
Reinforce safety of drugs, bio-products, health, herbal and veterinary Start Date: 1 March 201 12products across the value chain
End Date: 31 Dec 2012
Purpose To Reinforce safety of drugs, bio-products, health, herbal and veterinary products across thevalue chain
Support SFDA to:
Complete the veterinary products regulatory framework
Design and implement an adverse events reporting system for pesticides
- Develop and complete the regulatory framework for pharmaceutical establishments
Approve and monitor clinical trials with clear and exhaustive guidelines and appropriateexpertise and capabilities
Quality MethodMeans of verification, what method will beused to determine if quality criteria hasbeen met?
Expert Report
OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice
Activity Result 5 Pursue the development
(Atlas Activity ID) of
Purpose To Pursue the development of cosmetics standards and ensure the safety of cosmeticsproducts
Description Support SFDA to:
Finalize the structure of the cosmetics functions within SFDA
Pursue the listing and creation of standards for cosmetics products
-
how/with what indicators the quality of the Means of verification what method will beactivity result will be measured2 used to determine if quality criteria has
_________________
J been met?
LExpert feedback Expert Report
OUTPUT 3: Standards, control systems and pohces developed to cover food, drugs and medicaldevice
Activty Result 6
(Atlas Activity ID)
Purpose
1’ ghter SFDA s control v iia ufac. uring mport a d “xDort of f Start Date 1 March 201 12nedic.al devices
End Date 31 Dec 2012
To Tighten SFDA s control over manufactunng , import and export of medical devices
Description
Quality Criteriahow/with what indicators the quality of theactivity result will be measured2
Expert feedback
Date of AssessmentWhen will the assessmentof quality be performed2
Annually
_________
Quality Criteria Quality Method Date of AssessmentWhen will the assessmentof quality be performed?
Annually
ow/with what indicators the quality of the Means of verification what method will be When will the assessmentactivity result will be measured’? used to determine if quality criteria has of quality be performed’?
been met’?
Expert feedback —
______
Expert Report Annuafly
OUTPUT 3: Standards, control systems and policies developed to cover food, drugs and medicaldevice
rActivity Result 7 Develop best prachce pohces for specbc emergng product Start DateS 1 March 20112
(Atlas Activity ID) categoriesjte’31Dec_2012 —
Purpose To Develop best practice policies for specific / emerging product categories
Description Support SFDA to:
Draft, regulate & implement guidellnes for specific products
— Regulate & control the flow of special access medical devices
Implement & expand medical devices & establishments inspection program
- Introduce oversight over radiation emitting devices
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?
been met’?
Expert feedback Expert Report Annually
OUTPUT 4: Systems and processes to improve pro-activity in addressing emerging risk developed
Activity Result 1 Establish collaborative knowledge-sharing systems enabling Start Date: 1 March 20112. early detection of potential hazards to food and feed control(Aflas Activity ID) system
Purpose To Establish collaborative knowledge-sharing systems enabling early detection of potentialhazards to food and feed control system
Description Support SFDA to:
- Establish clear channels for feedback from external stakeholders. particularly private sector andconsumers
[ - Develop crisis management strategy to ensure emergency response preparedness
Quality Criteria Quality Method ‘I Date of Assessmenthow/with what indicators the quality of the Means of verification, what method will be When will the assessment ofactivity result will be measured? used to determine if quality criteria has quality be performed?
been met?
Expert feedback Expert Report Annually
Activity Result 2 Identify and swiftly act upon risks to patient safety Start Date: 1 March 201 12
(Atlas Activity ID) End Date: 31 Dec 2012
Purpose To Identify and swiftly act upon risks to patient safety
Description Support SFDA to:
- Develop a clear process for crisis management and ensure required capabilities are available
Quality Criteria Quality Method Date of Assessmenthow/with what indicators the quality of Means of verification, what method will be When will the assessment ofthe activity result will be measured? used to determine if quality criteria has been quality be performed?
met?
Expert feedback Expert Report Annually
OUTPUT 4: Systems and processes to improve pro-activity in addressing emerging risk developed
((SFDA finance team should discuss this with legal department after finalizing documentcontents))
VIII. LEGAL CONTEXT
This project document shall be the instrument referred to as such in Article 1 of the SBAA betweenthe Government of (country) and UNDP, signed on (date).
Consistent with the Article Ill of the Standard Basic Assistance Agreement, the responsibility forthe safety and security of the executing agency and its personnel and property, and of UNDP’sproperty in the executing agency’s custody, rests with the executing agency.The executing agency shall:
a) put in place an appropriate security plan and maintain the security plan, taking into accountthe security situation in the country where the project is being carried,
b) assume all risks and liabilities related to the executing agency’s security, and the fullimplementation of the security plan.
UNDP reserves the right to verify whether such a plan is in place, and to suggest modifications tothe plan when necessary. Failure to maintain and implement an appropriate security plan asrequired hereunder shall be deemed a breach of this agreement.
The executing agency agrees to undertake all reasonable efforts to ensure that none of the UNDPfunds received pursuant to the Project Document are used to provide support to individuals orentities associated with terrorism and that the recipients of any amounts provided by UNDPhereunder do not appear on the list maintained by the Security Council Committee establishedpursuant to resolution 1267 (1999). The list can be accessed via
This provision must be included inall sub-contracts or sub-agreements entered into under this Project Document.
IX. ANNEXES
Annex 1: Risk Analysis Log
Annex 2:Terms of Reference TOR for key project personnel should be developed and attached
Terms of Reference/Job Description for the respective long term advisors and short termxpertsiconsultants will be set Ut UOfl on- mencement of the project
An
nex
1
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le:
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ts—
_
Annex 2
TERMS OF REFERENCESSFDA Phase II
Post Title:
Background
Scope of work and Objective
Methodology
IV. Qualifications and Experience Required:
V. Duration:
VI. Duty Station:
VII. Payments:
VIII. Timing: