2011-12-30-世界卫生组织-INN_53rd_Executive_Summary_9页_184kb

53rd Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances - Summary

Introduction

The 53rd Consultation on INN for Pharmaceutical Substances took place in Geneva from 18-20 October 2011. The meeting included members of the INN Expert Group, the INN Advisory Group on biologics, the full INN Secretariat, and several specialists. Observers from various intergovernmental and national agencies were also present, including the British Approved Names (BAN), European Directorate for the Quality of Medicines (EDQM), IUPAC, Japanese Approved Names (JAN), USAN, USP, FDA, EMA, and WIPO.

The WHO highlighted ongoing reorganisation and financial challenges, including reduced donor income and the impact of the Swiss currency's strength. Despite these, the INN Programme remains self-financing and relatively unaffected by budget cuts. The Chair and Manager of the INN Programme expressed gratitude for the support from applicants, which helps sustain the programme.

INN Nomenclature

• 124 INN were discussed during the consultation.
• 93 new INN requests, including 43 for biological substances, were processed.
• 21 outstanding requests and 10 previously selected INN with objections were also reviewed.
• 107 new names were selected and will be published in List 107 of Proposed INN.
• 6 requests were deferred, 2 were rejected, and 3 were withdrawn.
• 4 amendments are planned for publication in List 107.
• New stems and sub-stems were selected, including -motide, -glutide, and -stim.
• New infixes were added, such as -ba and -taci for the stem -cept.
• The 2011 version of the "use of stems" document was presented and available on the INN Web pages.

INN Phonetics

• Pronunciation of INN is a neglected area.
• WHO previously used a phonetic translation system, but it is no longer in use.
• National bodies like USAN and BAN have their own pronunciation guides.
• Consistency in pronunciation is important, especially for stems.
• Regional variations in pronunciation exist, even in English, which can lead to misunderstandings in oral prescribing.
• Phonetics is a multilingual issue, not limited to English.

INN Stems for Modified Nucleosides

• A review of INN stems related to modified nucleosides was presented.
• There are currently over 250 stems in use, with 10 alternative stems for modified nucleosides.
• 4 stems relate to the heterocyclic base, 2 to the sugar moiety, 3 to antiviral action, and 1 to adenosine receptor agonists.
• The review includes lists of all INN under each stem, along with action and use, and chemical structures in annexes.
• The goal is to improve consistency and assist in the nomenclature of new modified nucleoside compounds.

IDMIS System

• The INN Secretariat aims to release INN data freely.
• A fee system will be introduced for those who benefit significantly from access.
• The Global INN Data Hub will be used to ensure WHO control over data dissemination.
• Names will be in images with watermarks to prevent unauthorized copying.
• Integrity (Thomson Reuters) contains INN data but requires a substantial fee for access.

Collaborators Updates

British Approved Names (BAN)

• BAN 2012 was published in August 2011, effective from 1 January 2012.
• Name similarity is a concern in the UK, especially with mercaptopurine and mercaptamine.

European Directorate for the Quality of Medicines (EDQM)

• PharmeEuropa will be digitally available only starting in January 2012.
• A survey on hydration is being conducted to improve naming consistency.
• The EDQM wants to harmonise the presentation of salts and align with INN practices.

International Union of Pure and Applied Chemistry (IUPAC)

• The Principles of Chemical Nomenclature (2011) and a new edition of the Compendium of Terminology are in preparation.

Japanese Pharmaceuticals and Medical Devices Agency (PMDA)

• The JAN and JP functions are now under the Division of Pharmacopoeia and Standards for Drugs.
• The 16th edition of JP is freely available online since April 2011, with an English version in development.

United States Approved Names (USAN)

• The 50th anniversary of the USAN Program was celebrated in July 2011.
• 49 INN applications were submitted for the 53rd Consultation.
• 68 USAN and 42 modified USAN were adopted in 2011.
• The 2012 USAN Council meeting is scheduled for 19-20 January 2012 in Florida.

United States Pharmacopeia (USP)

• The Pharmacopeial Forum (PF) is now only available online.
• Hydrates are not included in drug names unless they significantly alter the structure.
• Mis-prescribing between morphine and hydromorphone is a recurring issue, with the USP considering legal actions to resolve it.

European Medicines Agency (EMA)

• A new Executive Director, Prof. Guido Rasi, will take over from Dr. Thomas Lönngren on 15 November 2011.
• The Name Review Group has been restructured.

World Intellectual Property Organisation (WIPO)

• The Global Brand Database was launched in March 2011, including international trademarks, appellations of origin, and emblems.
• The database is searchable and will eventually include over 1 million trademarks.
• WIPO does not examine applications, only receives them.

Stakeholder Open Session

• The open session with stakeholders was held on 18 October 2010 (Annex to the summary).

• Bausch & Lomb and Nycox requested a two-word name for BOL-303259, a novel glaucoma treatment.

• The proposed name nitroxibutil latanoprotranate was suggested to avoid confusion with latanoprost.

• The Expert Group noted that this would contradict the usual INN naming conventions for esters.

• Grünenthal GmbH requested an INN for GRT6005, a novel centrally acting analgesic.

• The compound targets NOP and MOR receptors, and is in Phase 2a for pain management.

• A new stem is proposed to avoid misinterpretation and convey clear indications.

• Sandoz Pharmaceuticals presented data on glycosylation profiles of biopharmaceuticals.

• Aranesp®, MabThera®/Rituxan®, and Enbrel® were used as examples.

• Glycoform changes correlated with expiry dates, suggesting manufacturing process changes.

• The current INN policy on glycosylation is outdated, and new criteria are being considered based on clinical relevance and analytical advances.

Conclusion

• The 53rd Consultation highlighted ongoing challenges in drug nomenclature, particularly with biological substances.
• 46% of submissions were for biological substances, with a predicted increase in 2012.
• Stem creation, name clarity, and phonetics are key policy areas.
• The IDMIS system and Global INN Data Hub aim to enhance transparency and control over INN data.
• Stakeholder engagement is vital to avoid mis-prescribing and improve naming consistency.
• The 54th Consultation is scheduled for 1-3 May 2012 in Geneva.