The Pharmacogenomics Working Party (PgWP) provides recommendations to the Committee for Medicinal Products for Human Use (CHMP) on all matters relating directly or indirectly to pharmacogenomics.

The PgWP's tasks include:

  • hosting workshops and briefing meetings for CHMP pharmacogenomics experts and applicants to share experience on issues related to pharmacogenomics;
  • preparing, reviewing and updating guidelines for the preparation and assessment of the pharmacogenomics sections of regulatory submissions;
  • supporting dossier evaluation;
  • providing advice to the CHMP on general and product-specific matters relating to pharmacogenomics;
  • liaising with interested parties;
  • supporting the CHMP with its European and international co-operation efforts;
  • providing advice, through the CHMP, to the European Commission and the Mutual Recognition Facilitation Group (MRFG) on issues related to pharmacogenomics;
  • contributing to the organisation of training and workshops relating to pharmacogenomics.

Mandate, rules of procedure and work programme

More information on the PgWP's responsibilities and composition is available in these documents:

Mandate, objectives and rules of procedure for the CHMP PG Working Party

Reference Number: EMEA/CHMP/125959/2008 Rev. 1

English (EN) (54.73 KB - PDF)

First published: Last updated:
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Work plan for the Pharmacogenomics Working Party 2018

AdoptedReference Number: EMA/CHMP/370931/2017

English (EN) (117.33 KB - PDF)

First published: Last updated:
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Mandate, objectives and rules of procedure for the temporary working parties and drafting groups

Reference Number: EMA/CHMP/319651/2010

English (EN) (120.72 KB - PDF)

First published: Last updated:
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EMA has temporarily suspended or scaled back certain activities since 2019 based on EMA’s business continuity plan.

Composition

The PgWP is composed of experts selected from the list of European experts maintained by the Agency. A core group of up to 14 experts is nominated by the CHMP, based on their specific scientific expertise or regulatory experience.

Members

Below (in alphabetical order of surname) are the current members of the PgWP. The members' declarations of interests are available in the European expert list.

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