1. Regulatory Frameworks for Supply Chain Planning
Gladys Tetteh, MSH
Andualem Oumer, MSH
Joint Consultation on Seasonal Malaria Chemoprevention,
15th February 2017

2. Outline Objectives Background Regulatory framework
Country Case studies & Lessons learned
Recommendations

3. Objectives
To define the minimum requirements in terms of regulatory activities
To bring out the lessons learned around regulatory issues that affect supply chain management and availability of SMC medicines
To make recommendations that can be used to guide country programmatic planning

4. Background Gaps in tools recognized and being addressed
MMV has provided update on –
Availability - Current manufacturer and work to increase supplier base
Acceptability - Child-friendly formulation now available
Resistance - Next generation medicines under development
Quality - WHO pre-qualification processes
Availability, Quality, Child-friendly formulation gaps resolved
WHO prequalification – process whereby WHO is trying to ensure the Q, S, and Efficacy of medicines

5. Country Level Regulatory Framework
Why the need for country level regulation of pharmaceuticals?
Who is responsible to implement regulatory systems?
National Drug Regulatory Agency
Functions as part of the Health System
Selection
Use
Management
Support
Procurement
NDRA - Health System
Distribution
Policy & Legal Framework

6. Country Level Regulatory Framework
Components of pharmaceutical regulatory system
Licensing
Product evaluation & Registration
Inspection
Import control
Quality control
Control of promotion & advertising
Pharmaco-vigilance
Licensing of (manufacturing, importation, wholesale/retail dispensing outlets)
Inspection of (manufacturing, distribution channels, dispensing facilities
Quality control of products
Control of medicines, promotion & advertising
Price control
Control of prescribing, dispensing

7. Understanding Medicines Registration
When is medicines registration necessary?
New medicines
New formulations and/or route of administration
Different packaging and/or labeling
New indications/alterations to applications
Renewals
Stakeholders– regulatory authority, applicant (manufacturer or representative)
Processes – Submission of complete dossier and samples, review of dossiers and quality control of products, site inspection, deliberation and approval
Timeline – Anywhere from 1 month to 2 years (6 months)
NRA Roles – Clear guide for process, documentation requirements, application fee, time it takes in general
Have to review application, inspect facility, do quality control, deliberate and approve or reject or ask for more information/clarification
Applicant – Need to understand guidance and submit their complete application based on what is required (administrative, legal docs, sample of product, and different specific requirements based on formulations)

8. Registration requirements for countries
Country
System in place for medicines registration
Computerized
SOPs in place for medicines registration
Time needed for registration
Fast-track registration in place?
Conditions under which a product is eligible for fast-tracking
Burkina Faso
Yes
3 months on average No
None but DRA can give a waiver
Chad
120 days on average
Emergency context
Guinea
6 months
Epidemic outbreaks or natural disaster
Mali
4 months -
Niger
4-6 months
Products procured through national tender process
Nigeria
100 days from submission of samples
WHO pre-qualified products
The Gambia
1-3 months
Products for public health institutions

9. Country Example: Registration (NIGERIA) - 1
What was the challenge faced?
Delayed registration of SP+AQ dispersible tablets which delayed importation and use
What were the underlying issues?
Requirement: 100 days after submission of sample: WHO pre-qualification pdts may be fast tracked
Although manufacturer started registration process in August 2015; it was not possible to register SP+AQ dispersible tablets since inspection of manufacturing site had expired
What steps were taken to address the problem?
Coordination and advocacy involving NMEP and NAFDAC
Non-dispersible formulation planned for Cycle 1
Flagged it in February 2016
NAFDAC requested samples for vetting - March 2016
April 2016 – Guilin submitted samples
June 2016 – Coordination
June 9, 2016 – Guilin submitted letter to request fast-tracking of registration
July 8, 2016 – Notification for administrative approval

10. Country Example: Registration (NIGERIA) - 2
What were the results achieved?
Tentative approval in the form of administrative approval
What were the important lessons learnt?
Need to have robust plan and early coordination in place
Manufacturers and their agents need to keep track of registration status including inspection
Steps put in place to avoid the problem in the future?
Manufacturing site was inspected by NAFDAC in December 2016
Registration certificate should be obtained immediately
Early planning and development of comprehensive plan
Flagged it in February 2016
NAFDAC requested samples for vetting - March 2016
April 2016 – Guilin submitted samples
June 2016 – Coordination
June 9, 2016 – Guilin submitted letter to request fast-tracking of registration
July 8, 2016 – Notification for administrative approval

11. Understanding of Importation & Clearance Requirements
When is importation and clearance necessary?
When pharmaceuticals are manufactured outside of the country and need to be imported
Stakeholders – regulatory authority, manufacturer, procurement agent, forwarder/carrier, clearing agent, recipient, ministry of finance
Processes – Sending (pre)shipment clearance documents, writing waiver letters, obtaining waiver approval, processing clearance, transportation and delivery to CMSs
Timeline – Anytime from 5 days to 1 month
Waivers for – tax and registration

12. Importation and Clearance requirements for countries
Burkina Faso
Chad
Guinea
Mali
Nigeria
The Gambia
Is pre-shipment inspection a requirement? No
Yes
Port- clearance documents required
Pre-shipment vrs Actual Clearance
Airway bill/ Bill of lading 
Packing list
Commercial Invoice
Certificate of analysis X
Certificate of origin
Tax waivers
Donation certificate
How many days before arrival of shipments should pre-shipment documents arrive?
Two weeks
2 weeks
1 month
4 months
5 days

13. Country Example: Importation & Clearance of Medicines (NIGERIA) - 1
What was the challenge faced?
Delay in clearing of non-dispersible SP+AQ tablets
Delay in importation of SP+AQ dispersible tablets because of need for waiver
What were the underlying issues?
Requirements: Pre-shipment inspection required
Obtaining tax waiver by NMEP was delayed because no staff, no clear SOP for process, change of government financial policy (took a lot of time to figure out)
Manufacturer had produced SP+AQ dispersible tablets without NAFDAC registration number (requirement)
Certificate of No Objection was required
Payment of 250,000 Naira ($800) was required to get Certificate of No Objection

14. Country Example: Importation & Clearance of Medicines (NIGERIA) - 2
What steps were taken to address the problem?
NMEP applied for tax waiver using new process & staff
Submission of request for payment waiver by NMEP (July 20, 2016); Waiver request denied; Payment by manufacturer
What were the results achieved?
Tax waiver obtained; Products were cleared; campaign cycle 1 started one month late
Certificate of No Objection obtained
What were the important lessons learnt & steps put in place to avoid the problem in the future?
No SOPs for tax waiver process/only staff
Defining roles and responsibilities important
Early and comprehensive planning
Certificate of No Objection – Normally you have to be a legal representative of manufacturer to import. Last year CROWN agents did it; this year IDA – listed NMEP is recipient of product.

15. Understanding of Quality Control Processes
When is quality control necessary?
To identify quality, efficacy and safety issues of a finished pharmaceutical before or after it is available for public use
Stakeholders – regulatory authority, CMS, recipient (NMCP), testing laboratories ….
Processes – Sampling the right quantity, sending samples to laboratory, sample analysis, Sample result, notification of the results, actions based on results
Timeline – up to 45 days

16. Quality Control Requirements for countries
Do you ALWAYS conduct quality testing on WHO pre-qualified products? If yes, duration of testing process and costs?
Is there a way to fast track the testing process or get a waiver for the process? 
Country
Will quality testing need to be done on product samples
Burkina Faso
No. Testing is not mandatory for WHO pre-qualified products but a special import and exemption certificate is needed
Chad
Yes. This is a requirement. Takes 45 days but commodity distribution can proceed.
Guinea
No. Testing is not typically performed on WHO pre-qualified products.
Mali
Yes. This is a requirement. Takes one month but commodity distribution can proceed.
Niger
No testing likely
Nigeria
No need for testing; same product from same manufacturer imported in 2014
The Gambia
No requirement

17. Country Example: Quality Control (CHAD) - 1
What was the challenge faced?
Late of arrival medicines (July 2016); not enough time for QC resulting in delayed start of campaign (1 month shift)
What were the underlying issues?
QC is done in Europe; takes 45 days
Delayed delivery of products (expected in June for July start)
While batches taken for testing; approved distribution was halted (counter to regulation)
What steps were taken to address the problem?
Expedited clearance
Lobby with CPA for distribution while QC testing happened
Negotiated withNMCP & MSF to use available stock for cycle 1
Approval sought from WHO for late 4th cycle

18. Country Example: Quality Control (CHAD) - 2
What were the results achieved?
Cycle one happened with adequate products (although late)
Cycle 4 was still conducted in November
What were the important lessons learnt & steps put in place to avoid the problem in the future?
National regulation needs to be followed properly
Need for coordination and joint deliberation of issues
Early delivery of shipments to country by end-May to allow enough time for QC

19. Recommendations to guide Country Scale-up Plans
Stakeholder mapping
Engagement of stakeholders and coordination
Early planning
Incorporate all actions into planning, elaborate roles, responsibilities, timelines and resource requirements
Include relevant government agencies in planning, implementation & M&E
Finance relevant government agencies (allocation of funds for agencies to oversee/implement functions)
Monitor key milestones (gather evidence)
Keep discussing outstanding issues - ?Regionalization

20. Thank you