NIMPs (v IMPs): Definitions and Practical Approaches · NIMPs (v IMPs): Definitions and Practical...

NIMPs (v IMPs): Definitions and Practical Approaches

Esther Sadler-Williams

Global Director Strategic Development and Innovation

18th November 2015

©2015 Catalent Pharma Solutions. All rights reserved

Note: contributions are based on the individual’s knowledge and expertise; this presentation should not be construed as a statement or opinion by Catalent Pharma Solutions.

Disclaimer

©2015 Catalent Pharma Solutions. All rights reserved 1

2

Agenda

Current Status

• Definitions-

• Practical Approaches to Management

− Sourcing

− Labelling and Packaging

− Traceability, Complaints, Recalls,

Adverse Events

Impact of New CT regulations

Summary


Current Status - Define a NIMP?

Background

Medication

Concomitant

meds

Escape /

Rescue

meds

Diagnostic /

Endpoint

Medications

Preventive

Medication

‘Not being

tested’ Challenge /

Physiologic

response meds

Commercial

products?

Standard of

Care (SOC)


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Current Status

Regulatory Environment

• Currently no regulations around NIMPS

• Guidance from the European Commission*

— Defines nIMPs, provides examples, and required filing documentation

Non-Investigational Medicinal Product (NIMP)*

A medical product not defined within the description of an IMP and maybe considered a background (SOC), challenge, concomitant, endpoint or rescue medication (escape) dosed for preventive, diagnosis or therapeutic reasons. It can be provided by sponsor or study site.

Investigational Medicinal Product (IMP)**

A pharmaceutical form of an active or placebo being tested or used as a reference in a clinical trials including products with a marketing authorization but used or assembled (formulated or packaged) in a way different to the authorised form, or when used in an unauthorised indication or when used to gain further information about the authorised form.

*Euradlex Volume 10 – Chapter III March 2011 and **EU Directive 2001/20/EC; April 2001


Who and how to determine NIMP v IMP?


Which functional area is responsible for classification of study medication as either a NIMP or IMP? (select only one choice)

• Quality may often determine • Should have MA

–off label use more challenging

• Each case is different, depends on − Category and how its used − How drug regiment selected − Source − Presentation

• Complex… thus many just define as

IMPS!

Has your organization been challenged by a country Health Authority when classifying a clinical trial material

Summary of ISPE survey

ISPE Survey of 57 companies on various experiences with IMPs

• Most companies (78%) managed more than 25 protocols per year

• 30% of companies don’t distinguish between nIMPs an IMPs

• Sourcing

— 25% central; 58% local (22% sponsor controlled, 22% trial site order, 14% site inventory)

• 66% added some form of label to NIMP commercial packaging

6 ©2015 Catalent Pharma Solutions. All rights reserved

Practical Approaches- Sourcing of NIMPs

Sourcing Strategy will impact ‘practical’ management of IMPS

• Central, Local or ‘Blended Approach’

• Conduct ‘availability analysis’

• Consider MA status, availability, cost, import duties

Central Sourcing; bought in a single country to supply all

• Processes similar to IMPs

Local Sourcing; purchased in country where it will be used

• Country affiliate, third party or clinical site

• Specific considerations for Clinical site sourcing

• If used as per MA – no additional labelling unless competent authority specifies


Summary of NIMP Sourcing Strategy


Practical Approaches- Labelling of NIMPs

• IMP labelling requirements do not apply to NIMPs

• However.. some EU competent authorities have ‘stickering’ requirements

− Trial ID

− Sponsor

− ‘For Clinical Trial Use only’

• Labelling of Commercially available product

− Is it labelled according to MA?

− Ensure protocol defines product as a NIMP


How does your organization typically label commercially available NIMPs?

Practical Approaches- Packaging and Labelling of NIMPs

Generally approach depends on sourcing strategy

• Central Sourcing

− Re-label if

o country specific language not available

o Separating from commercial marketing presentation e.g single blisters removed from carton

o Altered commercial pack – authorities may consider as IMP

o If labelled need retain sample and QP release

• Local sourcing

− Country requirements may apply

− May need to consider ‘auxiliary label’ or ‘sticker’

o ‘For clinical trial use only’, Kit ID #

− Supports traceability and any integration to IRT

− Generally no retains or QP release as above details not considered as GMP label


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Practical Approaches for NIMPs- Other

Traceability: Records should document chain of custody

• Should be able to – ‘reconstruct movements of NIMPS’

• No regulatory requirements for returns and accountability for NIMPS

— But would be good practice

— To monitor safe handling and deviations from prescribed storage conditions that may impact the integrity of a NIMP

— To potentially support investigation of an adverse event for which the root cause may be a problem linked to drug

— To support a commercial recall

• If IRT used for traceability – need to affix ID label

Complaints and Recalls

• Should be part of Site Qualification process;

• Aligned to sourcing strategy but suggest manage as per IMPS

Adverse Event Management

• As IMPS ©2015 Catalent Pharma Solutions. All rights reserved 11

Impact of New CT regulations

In summary… Very Little!

NIMPs will become Auxiliary Medicinal Products (AMPs)

Definition: Medicinal product used for the needs of the clinical trial as described in the protocol but not as an Investigational Medicinal Product.

• Authorised – in any member state

• (unauthorised) - can be used in ‘justified cases’ (para 53)

• Be certain it’s a AMP! If required for the study.. Its an IMP

• Do not have to label AMP If commercial label provides all the information (para 57)

− Unauthorised AMP- labelling requirements same as IMP

− Specifics around radiopharmaceuticals

• Subjects should not have to pay for AMPs


Summary

NIMPs

• Be certain about your justification for categorisation

• Consider carefully sourcing strategy if appropriate to needs of protocol and clinical sites

• If sourcing locally often can minimise packaging and labelling needs

• May wish to consider ‘identifier’ auxiliary label for traceability

The future:

• New CT regs will provide more guidance than previously

• Other than a name change.. management will be similar to today


NIMPs (and IMPs)

Thank you for your attention

Esther Sadler-Williams

Catalent Pharma Solutions

+44-7711 853242

[email protected]


mailto:[email protected]

discover more. CATALENT PHARMA SOLUTIONS 14 SCHOOLHOUSE ROAD SOMERSET, NJ 08873

+ 1 866 720 3148

www.catalent.com

http://www.catalent.com

Summary of Approaches for NIMPS

Sourcing Strategy for NIMP

Sponsor label Overlay

Funded or re-imbursed by Sponsor

Return to sponsor for Destruction

Return for local Destruction

Return to Site Inventory

CENTRAL Yes Yes Yes Yes* No

No Yes Yes Yes* No

Locally Sourced at Site

Yes Yes Yes Yes* No

No Yes Yes Yes* No

No No No No* Yes

* Local destruction may be permissible


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