White Paper Regulatory Affairs Management Process v2

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PAPER
REGULATORY AFFAIRS MANAGEMENT PROCESSES
An organised and systematic approach is crucial for success
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1.
TYPICAL MANAGEMENT MODEL REGULATORY AFFAIRS

The following flowchart represents a typical multi-territory regulatory management process for
animal feed additive authorisations.

Databases

Two databases should be developed and maintained:

1.
Requirements Database

Developed by:

Researching regulatory requirements in territories of interest
Horizon scanning
Regulatory intelligence

The Requirements Database is continually kept up to date using horizon scanning and regulatory
intelligence strategies.

2.
Product and Process Database

This comprises existing and future data and information available for the product(s) concerned from:

Commercial/Market; for example,
o Customer requirements
o Market requirements
o Cost issues
Process/manufacturing; for example,
o Processes
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Materials
Quality Assurance (including external quality standards)
Quality Control
Legal compliance status (e.g. Feed Hygiene Regulations in EU)

In-house and out-of-house R and D;
o Often significantly influenced by external regulatory requirements (e.g. specific study
design requirements apply in the EU, Canada, USA)

Each of these databases informs and influences the other therefore it is important that processes for
communication between the two are established.

Regulatory Compliance Strategies

Developed from and influenced by the information in the Requirements and, Process and Product
Databases.

Regulatory Guidance

Regulatory Guidance should be a continual output of the management process to ensure that
ongoing and planned activities meet the regulatory requirements in the current and planned
business areas.

For example:

Commercial/Market
o Changes to Regulations could affect status of existing / planned authorisations
o Guidance on territory requirements and timelines to authorisation

Process/Manufacturing
o Guidance on labelling, ingredient selection
o Requirements relating to impurities

R and D
o Guidance on suitability of trial protocols; input to the development process to ensure
upcoming future requirements can be met

Commercial
o Guidance on territory requirements and timelines to authorisation.

2.
DATA, INFORMATION, AND KNOWLEDGE

At this stage it is important to clarify what is meant by data, information and knowledge. All
companies possess all three but few companies actually know the difference or have strategies in
place for managing them. This is surprising because much has been written on the subject. Detailed
exposition is outside of the scope of this document and what follows is simply a thumbnail sketch of
some basic definitions and principles.

o
o
o
o
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Data
A piece of data is a discrete objective fact about an object or an event; it is frequently unorganised
or unprocessed and is the raw material that is used to make information. You cannot use data to
make a decision because it has no meaning in and of itself; there is no structure and there are no
relationships between data entities. Frequently in Regulatory Affairs an organisation must make
decisions on the nature and volume of data required to create the information necessary to meet a
requirement. Often cost is a limiting factor in data generation and frequently quality is a limiting
factor in data usefulness.

Example of data: 25 60 47 12
Without context this data is meaningless.

Information
If a context is added to data it becomes information because context removes ambiguity. Context is
provided by categorising, calculating etc.; it provides answers to questions such as who, what,
where, when and how? I.e. information is aggregated data and it usually has some meaning and
purpose. Decisions are based on information (not data) but by itself information is insufficient for
good decision making. This is because information is simply contextualised data.

Example of information: 25C; 60% relative humidity; active ingredient content 47%; 12 months.
Now context has been added we have information which should have some practical use.

Knowledge
Knowledge can be defined as human understanding of a subject that has been obtained by study
and experience. If you have any knowledge of product stability testing you can immediately make
sense of the information example above;

Example of knowledge: after storage at 25C and 60% relative humidity
for 12 months our product retained only 47% of its active ingredient.
Now you can make a decision. The product is unstable; back to the drawing board!

Managing Data, Information, and Knowledge

Companies often have lots of data and frequently much of it is never turned into information. Data
generation for its own sake is pointless and there is a cost involved; if you arent going to use data
dont produce it. In addition, knowledge is frequently squandered by businesses, particularly in the
manufacturing sector. This is probably because knowledge, unless captured, is an ephemeral entity
usually held in the heads of a businesss experienced and expert personnel, and frequently, these
people are not managers, they are process workers and technicians. Therefore a strategy should be
developed and the processes for managing data, information and knowledge should be defined.

3.
PRODUCT REGULATORY PROCESS

A smooth and timely concept to authorisation experience is dependant on a systematic approach
to the project and effective project management. Frequently, establishing such an approach is a
culture shock, particularly if it is the case that individual departments communicate badly and
priorities and responsibilities are poorly defined. Therefore in order for the process to work effective
interdepartmental discipline and teamwork is required. The following diagram shows a typical
systematic approach and the use of classical project management techniques is also recommended.
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Step 1 - Commercial need identified

A commercial need for product authorisation has been identified.

Sometimes obtaining a product authorisation is driven by commercial vanity or for political reasons.
If this is detected then close attention must be paid to Step 3 where sometimes the costs and efforts
involved can prick this particular bubble. If close attention is not given to identifying requirements
and associated costs the commercial viability of a project may be overestimated.

Step 2 - Formulate commercial requirements and prepare request for authorisation

This step is extremely important; the following type of information should be collected and agreed
by all the stakeholders in the project:

Which geographical territory?
Will a regulatory partner (local actor) be used in that territory?
o If yes:
! what will be their role and the extent of their responsibilities?
! Will a service level agreement be required (recommended)?
! Will a non-disclosure agreement be required (recommended)?
! Will a Power of Attorney be required?
What is the proposed product name?
o Has a trademark check been done?
o Does the product name translate into the language of the target territory?
Has a catalogue or product code been assigned (these are sometimes required in technical
documentation)?
What expiry date / shelf life is required?
What is/are the target animal(s) (and crop(s) if a forage additive)?
What inclusion rates / application rates will be used?
Tons or tonnes (i.e. Imperial or metric measurement)
What label claims are required (i.e. what does the product do)?
What pack sizes will be marketed?
What packaging will be used (for each pack size)
o Primary packaging (in contact with product)
o Secondary packaging (boxes)
o Outers (cartons)
o Are packaging specifications available
! Drawings
! Technical (materials, thicknesses, weights, transmission properties)
o Will special packaging be required for the target market (for example, packaging with
improved moisture and oxygen transmission properties); if yes, will additional stability
studies be required?
What is required on the label?
What are the instructions for use?
What is the formulation?
Where do raw materials originate from (sometimes this can affect what documentation is
required)

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Step - 3 - Identify the regulatory requirements

At this step the regulatory requirements for product authorisation in the proposed territory must be
determined and this is often much more than a dossier. The information (regulations, guidelines
etc.) should be added to the Requirements Database. If local actors are being used they should be
consulted here to ensure that interpretation of requirements is accurate and to provide other
advice.

This step must include at least the following:

Identification of technical data requirements
Identification of the application and administrative processes.
Determination of the authorisation time line (i.e. time from submission of application to
authorisation).
Are translations required?
o If yes, translators should be given very precise instructions (see DP Consulting White
Paper - Guidance for Translation and Legalisation of Regulatory Files).
Will documents need to be notarised and legalised?
o Note that if translations and notarisation/legalisation is required the translator will
probably need a professional accreditation and the notary may require them to
present the translated documents in person.
Is sample submission part of the authorisation process?
o If yes processes for getting samples into the country concerned should be
investigated (e.g. are any specific additional documents required
Will a manufacturing site inspection be required?
What tariff codes apply (export UK/import country concerned); sometimes tariff codes
affect the technical documentation which may be required either during the authorisation
process or post-authorisation. In addition they can affect commercial viability.
Trademark checks if not already done.
What post-authorisation documentation will be required (e.g. Certificates of Analysis and/or
Manufacture; Certificates of Free Sales; copies of Import permits; health certificates etc.).
How long will an authorisation be valid?
What is the process required to renew/maintain an authorisation?
What happens if the product distributor is changed?
What happens if process changes are made (e.g. changes in: composition, raw material
sources, physical characteristics, shelf life, manufacturing process, branding etc.)
Are any business or process changes planned which may affect the product registration
process?
The costs of the process must be estimated.

Step - 4 - Do Data Gap Analysis

At this stage the territory data and information requirements should be matched to the available
material, assessing not just the availability but also data and information quality with respect to the
territory requirements (for example studies undertaken in the EU may not be suitable for use in the
USA). This process must also match product composition against territory requirements; for example
some product ingredients may be problematic in certain territories. A written gap analysis should be
produced highlighting missing material and offering possible strategies to provide solutions.

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It is at this stage that an up to date Product and Process Database comes into its own, or if it doesnt
yet exist it can be built as data and information is collected and reviewed.

Bearing in mind what has been said about data, information and knowledge above it is important
that the gap analysis is presented with the data in context (information) and makes use of
appropriate knowledge. Consultation within an organisation is therefore recommended.
Consideration should also be given to any overlap between other regulatory projects. For example it
might be possible to run some data generation for EU and USA projects side by side but there are
differing requirements cross-territory which must be taken into account.

Expert knowledge should also be made use of; for example, you may recommend that certain trials
are undertaken however an expert in the field may already know that there is a reason for the data
gap in the first place (e.g. the product is toxic to that particular target species; the product does not
work under those proposed conditions etc.).

Step 5 - Feasibility Assessment and Data Shopping List

The feasibility of authorisation should be evaluated based on the results of the gap analysis. Any
assumptions made should be identified and potential risks identified and quantified if possible. If the
project is judged feasible a Data Shopping List should be prepared.

Step 6 - Confirm Commercial Desirability and Assign Priority

This step is the hold and review point at which all the information gathered at Steps 3, 4 and 5
should be collated and reviewed. The project can then be reassessed commercially and priority
assigned.

Step 7 - Develop Project Plan

Project Management is outside of the scope of this White Paper but it is essential that a project plan
is developed which:

identifies all of the different phases and tasks;
identifies any dependencies;
assigns responsibilities;
formalises lines of communication (who needs to know what and when)
identifies costs;
estimates timescales
identifies risks
identifies hold and review points
etc.

Step 8 - Do Additional Research and Generate Additional Data

If required the additional research necessary to generate data identified as missing at Step 5 should
be undertaken paying close attention to the requirements of the intended market(s). Trial design is
crucial to success and you must not assume that the data you generate will be favourable; negative,
no-effect or equivocal (positive but not significant) results are not uncommon (indeed these
eventualities should be considered in project risks). Therefore build hold points in to data
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generation projects to identify stop or go situations (sometimes called a stage and gate
approach1).

Step 9 - Prepare Technical Documentation

The technical documentation should be prepared in accordance with the market requirements. This
step may also include the preparation of samples for testing by the competent authority in the
target country (the processes required for smooth sample submission should have been assessed in
Step 3).

If local actors are being used then effective collaboration is necessary. Identify who to communicate
with, the extent of their authority and their technical and administrative abilities. In addition
establish an effective file management (document control) process because it is likely that that you
will be working with numerous drafts. Ensure also that technical documentation is reviewed in-
house by people with the appropriate knowledge and expertise. Be aware also that the regulatory
business environment is dynamic and requirements may change during the drafting process. Often
this can be foreseen with effective regulatory horizon scanning. If foreseen, the impact should be
assessed. Also, it is not uncommon for a business to make changes to the processes involved in
manufacturing products or to other aspects of the business which can also have a significant effect.
For example: moving the site of manufacture could completely invalidate an application which
requires site specific information ; changing a raw material (usually a change for the better in
manufacturing terms) may also require a submission to be modified mid-process or even worse,
withdrawn and started again. In some territories for some types of product (e.g. EU zootechnical
feed additives) a change of ingredient (even if only an excipient) may invalidate some of the data it is
proposed to submit (e.g. stability data; efficacy data).

Step 10 - Make the Submission

At this stage review the application requirements because they may have changed since you first
identified them. It is a good idea to develop and use a submission checklist and if paper submissions
are required plan how you intend to produce, bind and index these.

Identify if there is a critical period post-submission; for example some authorities will undertake a
completeness or validity check and normally this takes place within 30 days of submission. Therefore
ensure that key personnel are available to respond to any issues that may arise at this point.

Step 11 - Support the Application

Ensure that you have the resources necessary to respond to any questions that may arise during the
assessment process. In some submission processes there are key timed milestones in which case you
must ensure that key personnel are on hand if likely to required.

Assessment questions may also affect project viability or call for changes to product characteristics
so you should ensure that their impact is properly evaluated and communicated to the project team.

If new files are required to be submitted during assessment dont ignore your previously established
document control processes.

1
See DP Consulting White Paper - Using a Stage and Gate Approach to Manage Regulatory Research and Data
Generation Projects.
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In the EU feed additive authorisation process it is possible to identify when the draft Opinion relating
to your particular application is scheduled for discussion by monitoring the FEEDAP panel meeting
agendas which are published on the EFSA website in advance. If your application appears on the
agenda then a published Opinion may be imminent. The EFSA Register of Questions Database is also
useful for monitoring the progress of all applications for authorisation for which EFSA has been
granted a mandate to assess.

In the EU feed additive authorisation process the scientific risk assessment panel will publish an
Opinion which is used by the European Commission to inform their risk management decisions (and
ultimately can determine whether an authorisation is granted or denied). These Opinions are issued
prior to publication under embargo and should be checked closely. Any identified errors should be
communicated to EFSA immediately. You may also wish to enter into a discussion about the
conclusions of the Opinion; by all means try though the chances of securing any changes prior to
publication are slim.

Step 12 - Authorisation

An authorisation may be granted with no conditions or alternatively on the understanding that
certain changes are made (e.g. this often happens for product labels) in which case go to Step 13.

Any authorisations which have conditions attached should be closely scrutinised. For example, in
some countries an import permit is granted which refers the regulatory standards which in turn
might affect the consignment shipping process (e.g. New Zealand). You should check that the
standards referred to are appropriate and the conditions that they impose can be met.

Step 13 - Modify product specification if required

Any changes/corrective actions resulting from the authorisation process should be managed using
an effective change control process. The changes involved (in non-EU markets) frequently involve
changes to labels which could also impact product literature.

Step 14 - Prepare post-authorisation documentation

Frequently post-authorisation (e.g. consignment) documentation is required and the nature and
content of this may be affected by the authorisation (see Step 12 above). The necessary
documentation should be drafted and if possible obtain an approval from your local agent or better
still, the competent authority before any goods are shipped.

Step 15 - Sell

The moment you have all been waiting for. Ensure that all your selling and marketing activities are
in accordance with the terms of your authorisation.

Step 16 - Maintain the authorisation

You should identify if and when any renewal or maintenance activity is required on the authorisation
and the requirements in the event of any significant changes to the product or manufacturing
process. In some territories additional data submissions may be required. Again, an effective change
control process within the business is crucial.

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4.
CONSCLUSIONS

A systematic approach to managing data, information and knowledge is required which should result
in sound regulatory compliance strategies.

A systematic, comprehensively cross-functional and project-managed approach should be adopted
which has hold and review points strategically scheduled.

Revision History

Version No
Date
1
Aug-2013
2
Jul-2014

Reason for Revision

New document
Section 2 added.
Step 2 and Step 3 expanded.

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REGULATORY AFFAIRS MANAGEMENT PROCESSES

Copyright D Pickard 2014

Reason for Revision

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