- Industry level .................................................................................................. 13
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1.
- A reflection paper
(RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work
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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.
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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
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new guidance in these areas to ensure these novel approaches meet the required evidentiary
standards and facilitate their evaluation.
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?
Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.
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?
Provide appropriate support to the EU network for generic and hybrid medicines including
product-specific requirements.
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2.3.
- ?
Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
based biopharmaceutics modelling (PBBM).
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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.
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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.
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4.2.
- ?
Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
assessment.
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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
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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.
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