idmp - identificationof medicinal products · pdf fileidmp - identificationof medicinal...

IDMP - IDentification of Medicinal Products

MARR CONSULTANCY

DEDICATED REGULATORY AFFAIRS EXPERTS ADDING VALUE

www.tracservices.co.uk +44 1209 612650

Learning Objectives

DEDICATED REGULATORY AFFAIRS EXPERTS ADDING VALUE www.tracservices.co.uk

+ What IDMP is

+ Main differences between IDMP and XEVMPD

+ Top 5 issues facing SMEs and how to tackle these

+ Latest information regarding implementation of IDMP

+ Advantages of IDMP

WHAT IS IDMP?


+ The IDentification of Medicinal Products

+ Devised by ISO - the International Organisation for Standardization

+ Comprises of five information management standards on the use, consumption and packaging of pharmaceuticals

+ Will eventually replace the current XEVMPD - eXtended EudraVigilance Medicinal Product Dictionary

+ Compulsory requirement in the EU with an implementation date of 1st July 2016 – although this will be phased

WHAT IS IDMP?


The main purpose of IDMP is to: standardise the way the pharmaceutical industry refers to medicinal products - a universal identification for drugs that can be referenced in individual case safety reports. The benefits are primarily aimed at patients; increasing the protection of public health by improving case evaluation and facilitating the earlier detection of potential safety issues through simplifying data exchange.

WHAT IS IDMP?


However companies are also recognising the internal benefits that can be achieved whilst preparing for IDMP compliance.

Real efficiencies can be seen by streamlining internal data control:

+ data standardisation

+ having one authoritative source to prevent discrepancies and increase control

+ improved data access and sharing

+ ease of data maintenance

+ increased understanding of own products

ISO STANDARDS


ISO 11615:2012 – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated medicinal product information.

This standard defines the product as per the marketing authorization, whether that is many pack configurations or one. This will be a new identification system that allows a product to be identified internationally. It is equivalent to the ‘authorized product’ in XEVMPD although more extensive and will require additional details such as: manufacturers, clinical information (indications, contraindications and side effects) and marketing authorization information. The level of detail required will be controlled by business rules implemented regionally.

ISO STANDARDS


ISO 11616:2012 – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated pharmaceutical product information.

This standard defines the pharmaceutical product in the administrable dosage form. Quite often a repeat of the information within ISO 11615:2012 but not necessarily. For example a solution for injection versus a powder and solution for injection which together form the administrable product. New pharmaceutical product identifiers (PhPIDs) will be assigned along with the route of administration.

ISO STANDARDS


ISO 11238:2012 – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on substances.

This standard covers the data required for uniquely identifying substances, including active ingredients, excipients, adjuvants and primary packaging materials. It will include the ability to define between grades of material and manufacturers.

ISO STANDARDS


ISO 11239:2012 – Identification of medicinal products – Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration, and packaging.

This standard defines the controlled vocabularies that will be used to ensure a standard global approach. These will cover pharmaceutical dose forms, units of presentation and routes of administration with some matching those used in XEVMPD. Packaging is a new addition to this concept so this controlled vocabulary will be new. These will all be global vocabularies.

ISO STANDARDS


ISO 11240:2012 – Identification of medicinal products – Data elements and structures for the unique identification and exchange of units of measurements.

This confirms the Unified Code for Units of Measurement (UCUM) standard which will be applied as the reference vocabulary for the strength of medicinal products. This standard is already used in XEVMPD and no further guidance will be released.

IDMP VS XEVMPD


The scope of IDMP is much larger than XEVMPD. Requiring more information, with higher levels of granularity and new controlled vocabularies, IDMP is going to require input and collaboration between multiple business units.

The data collected for IDMP compliance should form the basis of future submissions as part of a master data management (MDM) initiative. IDMP will require good quality data and internal processes in place to define the location, ownership and maintenance of this data.

Both key issues in many companies that need addressing now!

IDMP VS XEVMPD


TRAC IDMP SURVEY


TRAC wanted to understand the top issues facing SMEs and so conducted a survey of EMIG (Ethical Medicines Industry Group) members. Around 90% of responders confirmed that they would be directly affected by IDMP when it comes into force.

This included marketing authorisation holders through to companies that hold information that is identified to be in scope of IDMP.

TRAC IDMP SURVEY


The survey identified five common issues that SMEs are facing:

1. The implementation deadline

2. Lack of management buy in about the need to address IDMP

3. Time and resource needed to be ready for compliance

4. Lack of awareness of the EMA requirements

5. Current internal data control – data standardisation and harmonization

TRAC IDMP SURVEY


+ Cost was only ranked 7th in the list - given the scale of the IDMP requirements this will still be a critical area.

+ Areas of least concern were: Implementation Management and Ongoing Management

Further information and results are published on the TRAC website.

Andrew Marr


Andrew Marr has over 30 years experience working in Regulatory Operations and Regulatory Affairs. He has been the leading consultant on XEVMPD and the ISO IDMP standards since setting up Marr Consultancy Ltd in 2011.

Andrew is also a member of the EU ISO IDMP Task Force who had their last meeting on 12th June. The Task Force was established to pursue an open dialogue with industry to discuss aspects of implementing the IDMP standards in Europe, with the participation of terminology organisations, software vendors and developers of medicinal product dictionaries or databases. The Task Force will be responsible for advising on planning, development, implementation and maintenance of the ISO IDMP Standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles.

EU ISO IDMP Task Force


The EMA and the EU Regulatory Network are pursuing an open dialogue with industry to discuss aspects of implementing the ISO IDMP standards in Europe, by establishing an ISO IDMP Task Force, with the participation of terminology organisations, software vendors and developers of medicinal product dictionaries or databases.

The Task Force will be responsible for advising on planning, development, implementation and maintenance of the ISO IDMP Standards in the EU, in line with requirements defined at international level and based on agreed EU implementation principles. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&

http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000594.jsp&

Dr Andrew Marr EMIG

17 June 2015

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12 June 2015 meeting was to: ◦ Receive reports from the sub-groups actioned to develop

realistic plans for the implementation of IDMP ◦ To determine the recommendations to present to the Heads of

Medicines Agencies meeting 07-09 July 2015

The official implementation date remains 1 July 2016

European Commission is not yet in a position to offer an opinion regarding acceptability of other implementation timelines/strategies ◦ A meeting with the Commission to discuss the alternate

proposals will take place w/c 15 June

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Only one plan is being developed by the EU ISO IDMP Task Force, namely to have a phased approach to implementation ◦ No work is on-going to define a plan to fully meet a

deadline of 1 July 2016 ◦ Phased but dependent implementations for: Products Substances Organisations Referentials (vocabularies)

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5 iterations have been proposed Data elements for each phase are to be defined during July 2015

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It #

Scope Guidance Date

Start Implemn.

Enforce Implemn.

1 Content currently available in the Article 57 format and minimum required elements to assign and maintain identifiers for authorised medicinal products and support product life cycle management (MPIDs, PCIDs and PhPIDs)

In support of Pharmacovigilance, Regulatory Submissions (pre and post-authorisation), GMP/Inspections (specifically PV inspections), e-prescriptions (specifically cross-border identification of medicinal products in the EU)

Q1 2016 Q1 2017 XEVMPD supported

Q4 2017 XEVMPD no longer supported

2 Additional data elements and ISO IDMP 11615 content to support the assignment and maintenance of the Investigational Medicinal Product IDs (i.e. development products)

In support of Clinical Trial and pre-authorisation regulatory activities (e.g. excluding scientific advice, orphan and paediatrics application) and regulatory submission support (e.g. including the Clinical Trial Application)

Q4 2016 Q4 2017 Q2 2018

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It #

Scope Guidance Date

Start Implemn.

Enforce Implemn.

3 Remaining EU requirements for the Clinical Particulars section

In support of Pharmacovigilance and e-prescription

To be confirmed in 2016

4 Batch Identifiers and remaining EU ISO 11615 and ISO TS 20443 compliance

In support of GMP/Inspections (e.g. full traceability of medicinal products), scientific advice, orphan and paediatric applications, e-prescription, anti-falsified medicines

To be confirmed in 2016

5 Support for veterinary products To be determined

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4th Iteration

4th Iteration

3rd Iteration

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2nd Iteration

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4th Iteration

4th Iteration

3rd Iteration ?

? ?

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2nd Iteration

? ?

?

?

?

?

?

?

?

?

?

?

?

3 iterations have been proposed – nearly all in the first phase

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It #

Scope Guidance Date

Start Implemn.

Enforce Implemn.

1 Implementation of the minimum required mandatory elements as defined in ISO Technical Specification 19844

Q2 2016 Q2 2017 Q4 2017

2 Additional phase(s) to implement additional requirements outlined in the ISO TS 19844 in alignment with US

To be determined (not date yet)

3 Additional standards (to be confirmed) to support identification of substances on veterinary products

To be determined (not date yet)

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It #

Scope Implementation Date

1 Global vocabularies for ISO11239 (dose form, route of administration, unit of presentation and packaging) and ISO11240 (unit of measurement)

By end Q1 2016

2 Some vocabularies required to support first two iterations of Products and for Substances

By end Q2 2016

3 Remaining vocabularies required to support first two iterations of Products and for Substances

By end Q4 2016

4+

Implementation of additional vocabularies in support of subsequent iterations for Products and Substances

From Q4 2016

EMA will act as a Broker – simplest process

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EMA to act as Maintenance Organisation 3rd Party Identification to be required (GS1, Dun & Bradstreet etc.) May utilise an EU Organisation ID in addition Pre-registration of Organisations to be required (if legally possible)

It #

Scope Implementation Date

1 MA holders and unique MA contact persons By end Q1 2016

2 MA Applicants and regulatory authorities By end Q2 2016

3 Sponsor and contacts By end Q4 2016

4 Manufacturers (Supporting CAPs and NAPs) By end Q4 2017

5 CROs and Clinical Trials Sites and Data submitters on behalf of MAH/Sponsor/MA Applicant (to be confirmed)

By end Q4 2018

7-9 July meeting Short presentation - only 10-15 minutes Seeking agreement to move ahead with the plan

as outlined ◦ Dependency on acceptability to the European

Commission Informal communication of the outcome expected

from EMA to the EU IDMP Task Force as soon as possible after the meeting ◦ Formal communication to stakeholders will take longer

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Implementation deadline – Phased/more lead time Lack of management buy-in to the need to address

IDMP at the moment Time and resource needed to be ready for compliance

- Phased/more lead time ◦ Most difficult are left to 3rd and 4th iterations Overall resource requirements probably unaffected

Lack of awareness of what EMA will actually require ◦ HMA meeting/Commission position critical – communication

will be needed – July? ◦ Elements per Iteration essential – communication after July?

Current internal data control – data standardisation and harmonisation

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Clear implementation roadmap needed from EMA Ultimate scope remains large ◦ But each phase is more manageable

It is not only a project to support Pharmacovigilance activities - also ◦ Regulatory activities ◦ Inspections ◦ e-Prescriptions/Healthcare ◦ Product traceability

Need to understand current position in your companies ◦ Marketed products ◦ Investigational products

Recognised issues of: ◦ Data availability ◦ Data quality ◦ Authoritative sources ◦ And these are valuable internally too

Be able to plan – rather than react when it is too late

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Two stage approach? ◦ Analysis ◦ Implementation Planning Regulatory Other business areas Technical architecture Resources etc

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Initiate a ‘Pre-Project’ Vision and Strategy (Vision and Strategy) ◦ What is it that you want to do and how?

Current/near-future state assessment (Inventory) ◦ Gap analysis

Assess and report findings (Analyse) ◦ Recommendations

Consider technical solutions (Technical Options) ◦ Recommendations

Make business case for investment Monitor guidance/regulator’s plans

Initiate implementation

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?

Product Supply, CMC (&Regulatory)

Regulatory

Regulatory, PV (& Commercial)

CMC, Product Supply (&Regulatory)

Regulatory

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Regulatory , CMC & Product Supply

Regulatory, Labelling, PV (& Clinical)

Key is to: ◦ Understand the current situation and challenges (As Is) ◦ Define where you need to go (To Be)

Multiple sources of the same/similar data Lack of harmonisation – reducing interoperability Useful data trapped in documents

IDMP has not created this situation ◦ It has highlighted it ◦ There is a lot a value in improving data management without IDMP ◦ IDMP can/should act as a driver

You have to want to do it not just being forced to do it!

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Regulatory Affairs

Safety

Regulatory Authority

Authority Objective Establish a consolidated view of a substance/product across different source of information

Increased provision of electronic data and documents – multiple sources of related/dependent data

How can the MAH replicate what the Authority has?

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Audit

GCP

GMP

Learning Outcomes


+ What IDMP is

+ Main differences between IDMP and XEVMPD

+ Top 5 issues facing SMEs and how to work through these

+ Latest information regarding implementation of IDMP

+ Advantages of IDMP

CONTACT


[email protected] www.tracservices.co.uk [email protected] www.marrconsultancy.com

mailto:[email protected]

http://www.tracservices.co.uk/

mailto:[email protected]

http://www.marrconsultancy.com/

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