Based upon WHO Guidance for vector approvals, NASEM, FNIH and UCI MI project plan

1) Determine final site. Finalize decision on partner institution and local PI, who should represent the project in stakeholder engagement with the PNLP of Comoros and STP, (Programme National de Lutte contre le Paludisme)

Contact to see if there is interest and capacity to begin
Compile contact listing
Send out introduction emails, letters etc.
Arrange meeting
Draft agreements
Chart responsibilities
Local informational workshop venue
Presentations
Materials
Hire local staff
PI approvals
Finalize contracts

2) Complete TPP

3) Field protocols

4) Laboratory approvals

5) Train staff

UC I Þ SITEÞINTERNATIONAL AND NGO

6) Make contact with Biosafety Clearing House focal point for Comoros, who can help clarify the regulatory pathway for LMOs (Will check with Tony on this). Mlle Assani Moinahalima

Spécialiste en Gestion et Conservation de la Biodiversité

Direction Générale de l'Environnement et des Forêts

Ministère de l'Agriculture, de la Pêche, de l'Environnement, de l'Aménagement du territoire et de l'Urbanisme BP 5414 Moroni Comoros

Phone: +260 334 31 02

Email: assanimoinahalima@yahoo.fr

3. Determine status of national biosafety law, application and review process (There are none in the Comoros, not even for agriculture, they do not restrict GMO)

4. Encourage national authorities to request training and support from AUDA-NEPAD –(Requested that our Community Engagement consultant, Ana Kormos engage on the subject with our partners in the Comoros)

5. Focus initially on requirements for contained use

6. Establish IBC at partner (Local PI) University (STP or Comoros )

7. Determine requirements of Comoros/STP responsible authority (Ministry of Environment?) for certification of contained use facility for gene drive mosquitoes, Adapt crop policy, such as exists in Burkina faso.

a. Comoros has no GM rules or guidance

b. Sao Tome has no capacity to enforce

8. Establish plan and timeline for building containment facility at partner institution. (ACL2 + should be a priority and be complete before training of local postdocs or scientist)

9. Identify trainee candidates and establish timeline for training that correlates with completion of containment facility.

10. Check with the university/PNLP to make sure they understand the technology (especially the persistence issue) and feel comfortable that their insurance adequately covers the field work

11. CISRO will be unable to hold a slot for Risk assessment and we should consider engaging with them soon for a projected time frame for assessment.

• Consider reaching out to Tanzania

12. Obtain copies of previously approved ACL2 + laboratories in Africa

13. Conduct hazard analysis with the research team (including representatives from the field site) and any external experts desired by the project. The project may choose to stop there.

“Hazard analysis is the first step in risk assessment. A hazard analysis is a systematic exercise to think collectively about everything that could potentially go wrong with the system, no matter how unlikely. The hazard analysis will include consideration of the possible steps that would have to occur for each of these hazards to occur (the pathway to harm). Early hazard analysis is a benefit to the project. The utility is that it helps the project identify data or information that may be needed to predict the probability that any of the steps in the pathway to harm might occur. Prediction of the probability that a hazard will occur, and the consequence if it does, is part of risk assessment. If risk assessment determines that a particular hazard has a high level of probability, or a high level of uncertainty, this may cause the project to have to stop and go back to collect missing data, which could result in serious delays.”

14. Risk assessment will be conducted by national regulatory authority(ies) in any case, but this is unlikely to conform to the NASEM recommendation for probabilistic ecological risk assessment of gene drive organisms. An external risk assessment that is made public by the project can help with transparency issues later on and provide information that may be useful to national authorities in their own risk assessment. (Review Mark Benedick Pathway to Development)

15. Local Approvals and requirements

Permits

Scientific Review

Contracts

Visas

Approvals

16. Initiate WHO l approvals

Assesses Quality, Safety, and Efficacy of manufacturing facilities (Continuous)

WHO Prequalification Team Vector control products MVP/EMP/RHT/PQT World Health Organization 20, Avenue Appia 1211 Geneva 27 Switzerland

Single point of entry (PQT-VC) Electronic submission and one hard copy.
Service Code
Service
PQ100 Request for Determination of Pathway
PQ200 Protocol Review
PQ300 New Vector Control Product PQ301 New Equivalent Vector Control Product
PQ400 Active Ingredient: New Manufacturing Site PQ401 New Active Ingredient Hazard Assessment via JMPR
PQ40 New Active Ingredient Hazzard Assessment via JMPR
PQ500 Post PQ Change: Major PQ501 Post PQ Change: Minor
PQ501 Post PQ changes Minor/Major

New interventions Pathway

1) Cover letter requesting Service PQ100

2) Dossier, letters forms, studies, data, (living document using GLP)

Cover letter
Application form
Table of Contents
Letter(s) of authorization
Letter(s) of access
Declaration of Labelling

3) Request for Determination of Pathway Form ◦ Handout

4) Draft Label (if available)

5) Additional supporting documentation

6) Submit to the PQT-VC Case Managers via pqvectorcontrol@who.int

7) http://www.who.int/pq-vector-control/resources/presubmission/en/

8) Meeting requests, Submit to the PQT-VC Case Managers via pqvectorcontrol@who.int

Dossier requirements

Example of cover letter

University of California Approvals
Site Ministry Approvals
1. Community Consent
2. International and NGO approvals

Example of Letter of Authorization

Example of Letter of Access

Example of labeling

Appendix 1 Guiding Principles

Engagement with colleagues, partners, all stakeholders

• Practice openness and transparency

• Collaborate, engage, and listen through proactive/constructive 2-way communication

• Demonstrate integrity (judgement/confidentiality/tact/consistency)

• Be respectful and demonstrate respect

Process and Decision Making

• Action oriented, i.e., value-added processes which focus on end user access to products

• Evidence-based

• Adhere to established roles and responsibilities

• Transparent

• Timely

• Well documented policies and decisions

• Continuous evaluation and process improvement

Broader Impact

• Embrace innovation and creativity

• Apply a global perspective to meet varying geographic and disease needs

• Monitor and evaluate current approaches to meet changing global needs, i.e., remain relevant

Summaries:

1) Summary of Quality Dossier

Physical/Chemical Data
Declaration of Product Formulation
Description of Manufacturing Process
Declaration of Manufacturing Sites
Confidential Appendices

2) Summary of Safety Dossier

*Acute toxicology (6-pack) - Acute Inhalation - Acute Oral - Acute Dermal - Primary Eye Irritation - Primary Skin Irritation - Dermal Sensitization
Product Risk Assessment (Occupational and Residential Exposure)
AI Specific Hazard Assessment (or summary of publically available information)

3) Summary of Efficacy Dossier

Lab studies
Field studies
Supporting Documentation

*TPP

	File	Modified
Labels No labels Preview View	Microsoft Word Document UCI MI Regulatory plan.docx	Jul 19, 2019 by Sentelle Eubanks

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