Mónica Garcia-AlonsoEstel Consult Ltd.mgarcia@estelconsult.com

Writing Regulatory Dossiers: Good Reports, Good Dossiers, Good Stories

SABC, September 2016

INTRODUCTION

Before GM crops can released into the environment or consumed by humans or animals, developers must apply for approval to local regulatory authorities

• Approvals are given at country level, under a certain regulation.

• A regulatory application must be submitted containing sufficient data to allow an evaluation of the safety of the product. Often referred to as a “dossier”.

• Regulators scrutinise the dossier, ensure it provides the data necessary to decide whether the proposed use of the product will be safe.

REGULATORY SUBMISSIONS

OBJECTIVE

To prepare a regulatory dossier that maximises the probability to obtain an approval in an efficient and timely manner

REGULATORY SUBMISSIONS

OBJECTIVES

A good regulatory submission is more likely to lead to timely approvals

• Provides the information necessary, presented in such way that allows effective decision making

SMOOTH PATH

OBSTACLES

REGULATORY SUBMISSIONS

A bad regulatory submission can delay the approval

• Wastes your time and evaluators time

• Erodes the relationship-mistrust

• Could lead to serious delays in country/internationally and even compromise the approval

FACTORS THAT CONTRIBUTE TO A GOOD REGULATORY SUBMISSION

GOOD PLANNING

• Development of a regulatory strategy with a clear plan for compilation of relevant information and relevant data very early on in the project.

GOOD DATA COLLECTION

• Good, well reported, relevant data

• All required data

GOOD PRESENTATION

• Presenting the data in a clear logical way (telling a good story)

REGULATORY SUBMISSIONS

DISCOVERY PROOF OF CONCEPT

EARLY DEVELOPMENT

ADVANCED DEVELOPMENT

PRE-LAUNCH

3 4 5 6 7 8 9 10 11 12 13 14 151 2

1000-100 lines 100-10 lines

Event Selection

Laboratory Research confined FT Regulatory package

Event bred into commercial

varieties

Regulatory submission

Based on Privalle et al, 2013

Lab books Lab & Fieldbooks

Regulatory reports

REGULATORY DOSSIER

FACTORS THAT CONTRIBUTE TO A GOOD REGULATORY SUBMISSION

GOOD PLANNING

• While the product is in development, construct a regulatory plan

• List of countries regulatory submissions will be sent (cultivation of food/feed)

• List of regulatory studies: with expected start and completion date of the study AND planning time for the completion of the report

• Write regulatory reports as studies are completed

• Archive all documents (books and reports) efficiently:

• Need to find the reports quickly

• Need to track versions of reports

REGULATORY SUBMISSIONS

REGULATORY SUBMISSIONS

LABORATORY BOOKS

FIELD BOOKS

REGULATORY REPORT

REGLATORY DOSSIER

• Data recording that follows standard scientific data recording methods

• Aims at noting down experiments, the methods used, the results,…

• Often used for scientific publication

• Follows a well established methodology to test a defined risk hypothesis

• Accurate recording of materials, methods and results• Contains all raw data generated

• Follows in country format• Contains all data required (summaries and reports)• Puts the data in context to facilitate decision making

DATA COLLECTION:

Data for regulatory reports

• Address specific concerns (hypothesis) determined by specific

protection goals and assessment endpoints

• Data collected following well established methods , accepted

standards, specific endpoints or recommended criteria

• Aim at providing answers to specific questions, not at opening

new ones

• Conducted to standards that would be as good as or even greater

than standards set for peer-reviewed publications

REGULATORY SUBMISSIONS

REGULATORY REPORTS

Rigorously planned, executed and recorded

• Protocols describing the purpose of the study, the methods to use, the materials, the measurement endpoints and how the data will be analysed are prepared before the studies begin

• Notes are taken throughout the study, noting any deviations from the protocol and recording all the data

• Appropriate statistical analyses are conducted and the choice of analysis is justified

• Raw data is provided, allows others to do statistical analyses to corroborate results.

REGULATORY SUBMISSIONS

GOOD REGULATORY REPORTS

REGULATORY STUDY REPORTS: Typical structure

REGULATORY SUBMISSIONS

Slide by Don MacKenzie

REGULATORY REPORTS

A comprehensive study report is written describing the materials and methods, the endpoints, the data generated (including ALL the raw data), the analysis conducted and the conclusions.

REGULATORY SUBMISSIONS

Good studies and study reports are essential for building and writing good regulatory dossiers

REGULATORY STUDY REPORTS

Usually, one study, one report

The individual study reports should stand on their own.

• They can support various submissions for the same product (e.g. when submitting for approvals of the product in different countries and/or different uses)

• They can support submissions for different products (e.g. event independent protein studies that can support GM products based on different crops)

REGULATORY SUBMISSIONS

Data transportability

KEY CONSIDERATIONS FOR GOOD REGULATORY DOSSIERS

REGULATORY DATA

• Complies with local requirements

• If the regulation in the country requires the use of particular methods, these must be used or a justification of why they were not must be provided. A pre-submission consultation is advisable

• All data requirements are fulfilled

• All the data required in the country must be provided or justification must be given

REGULATORY SUBMISSIONS

REGULATORY STUDY REPORTS:

Typical reports in a submission

REGULATORY SUBMISSIONS

By Don MacKenzie

KEY CONSIDERATIONS FOR GOOD DOSSIERS

FORMAT

• The objective is to prepare dossiers that will support your application and can be effectively reviewed by local regulatory authorities

• Comply with local regulations

• There may be different procedures for different types of applications

• Field trials

• Food and Feed use

• Commercial cultivation

REGULATORY SUBMISSIONS

TELLING A GOOD STORY

It is very easy to just “throw” information at the dossier, but that may not help in getting a time efficient review

• Putting the information gathered and the data generated into context gives a more

clear rationale to the dossier

• Inexperienced regulators may really appreciate this-capacity building

• Data that does not add information relevant for the assessment will be reviewed,

may open questions and may delay the process

• Summarising relevant data eases the job of the evaluator and helps the story along.

Examples:

• When collecting available information on the biology of the recipient crop, extract the

relevant information, rather than adding the whole OECD report

• When using data from a regulatory study to support an argumentation, summarise the

study pointing out what part of the study supports your conclusion

DOSSIER PREPARATION

TELLING A GOOD STORY

Too much detail:

• “clutters” the dossier

• Makes it look like you do not know what your data means or how to select what is relevant

• Wastes valuable time

Too little detail:

• Casts doubts on your dossier and whether you have provided enough data or if your data is of sufficient quality

• Wastes valuable time

DOSSIER PREPARATION

FACILITATE THE REVIEW

Guide the regulator through the dossier:

• Provide a story with a good flow

• Explain the rationale

• Cross-reference to the sources of data, making it easier for the reviewer to find the relevant information in the reports or in citations.

• Support all statements with either publications or a link to the data used to make the statement.

• Summarise key data-they will appreciate this and may use it when they write their assessment report

DOSSIER PREPARATION

FACILITATE THE REVIEW

Do not make the evaluator chase the data (“treasure hunts” when you are busy can be frustrating), facilitate their work

• Provide all the study reports used (as appendices)

• Provide a complete list of references- make sure that regulators can easily find them or even better, give them an electronic copy, if possible.

DOSSIER PREPARATION

WRITING THE DOSSIER

Use relevant and reliable information

Sources of information (from OGTR, 2009)

DOSSIER PREPARATION

SUMMARY

Dossier preparation should start as soon as the event is selected and regulatory data is collectedDossiers should be prepared in a way that they facilitate decision making.• Written in a clear and logical way: “telling the story”

• The methods used, should be clearly described and based on sound science

• The data must be relevant and fully supported by study reports and/or publications

A good dossier helps evaluators finding information and speeds the review process

THANK YOU FOR YOUR ATTENTION!Hoping that your path is a smooth one

SMOOTH PATH