HIS/EMP | Communications Planning San Diego, December 2017 FIP World Congress, 10-14 September Dr Raffaella Balocco, INN Programme, WHO Nomen Omen The INN Programme: scope and policies Dr Raffaella Balocco Mattavelli, WHO INN Programme Antibody Engineering & Therapeutics December 11-15, 2017, San Diego, CA
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HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Nomen OmenThe INN Programme: scope and policies
Dr Raffaella Balocco Mattavelli, WHO INN Programme
Antibody Engineering & Therapeutics
December 11-15, 2017, San Diego, CA
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
What's in a name?
Safety
Quality
Information
RegulationRational use use
Procurement
Efficacy
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Verba volant scripta manent
"By assigning a single international name to drugs, WHO helps ensure that a prescription filled abroad is what doctor ordered back home."
Dr Margaret Chan,
Former WHO Director General
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
WHO some basic facts
194 Member States
Two governing bodies: - World Health Assembly - Executive Board
WHO Secretariat: - HQ- six Regional Offices- WHO Expert Panels
(e.g... on the International Pharmacopoeia and Pharmaceutical Preparations etc.)
Constitution 1946, in force since 7 April 1948(World Health Day)
Article 2 (u) International standards
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
WHO's constitution
Inter alia:
to act as the directing and coordinating authority on international health work
to develop, establish and promote international standards for food, biological, pharmaceutical and similar products
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
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
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INN Programme
To devise a single name for a substance
INNs are recognized in almost all Member States
INNs can be used freely and cannot be registered as trade names
Not concerned with formulations
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Interested parties outside WHO
USAN Program
Pharmacopoeias
(BP, FP, USP, JP….)
European Commission,
WCO, WIPO, …
Research based
industry
National trade-mark
authorities
DRAs(EMA, US-FDA….)
INN Programme
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Various trade names ® for one substance, ex. paracetamol
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Various generic names for one substance, ex. paracetamol
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
One International Nonproprietary Name for one substance, ex. paracetamol
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INNs…
Unique name
Distinctive in sound and spelling
Not liable to confusion with other names in common use
Formally placed by WHO in the public domain
Can be used without any restriction to identify pharmaceutical substances
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
The INN System
WHO Secretariat
INN Expert Group
INN Advisory Groups on Biologicals, publications etc.
Publications
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
The Business Process Model
Broad consultation
Lot of correspondence
2 INN meetings/year
"Ad hoc" meetings……
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
INN selection process
➢ Secretariat receives INN applications
➢ Consultation / INN Expert Group
➢ Secretariat informs applicants
➢ Validation of Information
➢ Published in a List of proposed INN
➢ 4-month period for objections and comments
➢ Published in a List of recommended INN
Clinical Phase I
Use code pending
r.INN assignment
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
General Principles in devising INN
INN should not be too long
Isolated letters, numbers to be avoided
Anatomical, physiological, therapeuticalconnotations, trademarks conflicts to be avoided (cardioprofen, superprofen, cancerprofen, panadolprofen)
Transliteration issues"f" instead of "ph" "t" instead of "th"
"i" instead of "y" avoid "h" and "k"
HIS/EMP | Communications PlanningSan Diego, December 2017FIP World Congress, 10-14 September
Dr Raffaella Balocco, INN Programme, WHO
Use of stems
To indicate chemical and /or pharmacological group relationship
Published for 'established series of related compounds'▪ Fantasy prefix + -stem as a suffix: tazobactam (63)(29)
▪ Fantasy prefix + -stem- as an infix: misoprostol (47)(22)
▪ Stem- as a prefix +fantasy suffix: cefuroxime (34)(16)
INN and stems have protection within trade mark arena
WHO publication "The use of stems in the selection of INN " Stem book 2013+ Addendum (when necessary)