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Published on: August 4, 2023
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Harmonising nomenclature in pharmacopeial texts
1School of Pharmacy, Newcastle University, Newcastle upon Tyne, UK.
Summary
Scientific nomenclature in pharmaceutical regulation causes debate. Harmonizing terminology across US, EU, and Japan pharmacopeias is crucial for global medicine approval and regulatory standards.
Area of Science:
- Pharmaceutical regulation
- Pharmacopeial standards
- Global medicine approval
Background:
- Nomenclature debates can arise from linguistic and philosophical differences between expert groups.
- Varying interpretations of technical language in pharmacopeial texts can hinder regulatory harmonization efforts for new medicines.
- Discrepancies in pharmacopeial texts from the US, EU, and Japan are presented as examples.
Discussion:
- Divergence in pharmacopeial texts can stem from differing interpretations of scientific terminology.
- These variations can create inconsistencies in regulatory approval mechanisms for pharmaceuticals.
- Addressing these differences is vital for streamlining the global pharmaceutical market.
Key Insights:
- Three specific examples of nomenclature divergence in US, EU, and Japanese pharmacopeias are detailed.
- The emergence of these divergences is analyzed, highlighting potential causes.
- The need for a unified approach to terminology is emphasized.
Outlook:
- Advocating for a consensus on agreed-upon terminology for the global pharmaceutical industry.
- Proposing a standardized nomenclature to prevent reintroduction of variation via individual agreements.
- Promoting consistent regulatory standards worldwide through harmonized terminology.
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