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Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

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Wednesday, February 14, 2024

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Industry level .................................................................................................. 13

Key Points:

Industry level .................................................................................................. 13
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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1.
A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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plan, and it is envisaged that something similar may be needed for other emerging treatment
modalities (e.g., peptides).
Guideline work led by other working parties
?
Revision of the guideline on the requirements for clinical documentation for orally inhaled
products (CPMP/EWP/4151/00 Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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The planned concept papers (CPs) will formulate problem statements for potential workshops and
subsequent guidance documents will be informed and enriched by the outcome of discussions of
workshops to be held in 2024.
Guideline work led by other working parties and committees
?
Revision of Guidance on the investigation of medicinal products in the term and preterm
neonate (EMEA/536810/2008).
There is a need for
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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2.3.
?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

In order to support adequate evaluation of all methodology MWP will aim to facilitate an
increase in presence and visibility in relevant committees of methodological expertise from
across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
depot) and melatonin have been prioritised as the next in series for drafting.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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4.2.
?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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?

To deliver an improved access to raw data (e.g.
?
Propose regulatory research priorities for funders in across the activities of Methodology
Working Party, including in the big data area.
?
Establish key communication points in national competent authorities and build a resource of
key messages and communication materials on regulation and methodology.
The timing of workshops may need to be arranged according to the
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023

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specific needs of the guidance ? either before the guidance is finalised to gather views and
expertise; or once it is finalised for training purposes.
Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
EMA/CHMP/58124/2023
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