IPRP Working Groups

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/working-group/bioequivalence-generics
2018-08-03
The Bioequivalence Working Group for Generics (BEWGG) covers the application and interpretation of bioequivalence requirements as well as information and procedures for the assessment of
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/working-group/biosimilars
2018-06-05
The Biosimilars Working Group (BWG) provides meaningful outcome to promote public health through more affordable biosimilar products.   Mandate 1. General considerations The
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/working-group/cell-therapy
2018-08-03
The Cell Therapy Working Group (CTWG)’s primary goals are open discussion and sharing of best practices for the regulation of cell and tissue-based therapies, as well as support of harmonization
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/working-group/gene-therapy
2018-06-04
The Gene Therapy Working Group (GTWG)’s objective is to discuss emerging scientific developments and concerns for the regulation of Gene Therapy (GT) products and to share regional updates in
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/working-group/identification-medicinal-products
2018-08-03
The Identification of Medicinal Products Working Group (IDMPWG)’s work is to ensure the awareness and understanding of the IDMP standards by pharmaceutical regulators, to clarify how and why these
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/working-group/information-sharing-generics
2018-08-03
The Information Sharing Working Group for Generics (IWGG) is a pilot for the sharing of information on the evaluation of Generic Drug applications involving the Decentralised Procedure (DCP) and
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/working-group/nanomedicines
2018-08-03
The Nanomedicines Working Group (NWG) works on the exchange of non-confidential information on nanomedicines and nanomaterial in drug products and borderline and combination products.  
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/working-group/quality-generics
2018-08-03
The Quality Working Group for Generics (QWGG) focuses on technical requirements, procedures and tools for the assessment of Quality information related to ASMFs/DMFs and generic drug products.