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International Nonproprietary Name (INN) Programme

International Nonproprietary Name (INN) Programme. The WHO International Nonproprietary Name (INN) Programme. To provide one single name worldwide for active pharmaceutical substances. Initiated in 1950 by resolution WHA3.11 Operational since 1953 Based on WHO Constitution.

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International Nonproprietary Name (INN) Programme

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  1. International Nonproprietary Name (INN) Programme

  2. The WHO International Nonproprietary Name (INN) Programme To provide one single name worldwide for active pharmaceutical substances • Initiated in 1950 by resolution WHA3.11 • Operational since 1953 • Based on WHO Constitution

  3. WHA46.19 resolution requests Member States: 1) …..to ensure that INNs … in labelling and advertising of pharmaceutical products are displayed prominently; 2) to encourage manufacturers to rely on their corporate name and the INNs, rather than on trade marks, to promote and market multisource products …; 3) to develop policy guidelines on protection of INNs, and discourage the use of names derived from INNs and INN stems as trade-marks.

  4. Department of Medicines Policy and Standards (PSM)Quality Assurance & Safety: Medicines (QSM) QSB

  5. Interested parties outside WHO

  6. INN – in practice (-)-6(2amino-phenylacetamido)-3,3-demethyl-7-oxo-4-thia-1-azabicyclo [3.2.0]heptane-2-carboxylic acid ampicillin [3B-L-lysine,29B-L-glutamic acid]insulin (human) insulin glulisine

  7. Gene Therapy Word 1: gene component

  8. Gene Therapy Word 2: vector component

  9. Improved system • Defined and documented business process • Improved tools for WHO’s scientific screening process • Web-based request status • Web-based on-line queries Recent progress

  10. Challenges • Protection of INNs: need to improve collaboration with DRAs • Userfriendlyness of INNs: need to avoid unpronounceable INNs that discourage use of generic names • Biologicals…biosimilars…

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