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Different pharmaceutical products need similar terminology
Daan J A Crommelin1, Jon S B de Vlieger, Vera Weinstein
1Department of Pharmaceutical Sciences, Utrecht University, P.O. Box 80.082, 3508 TB, Utrecht, The Netherlands.
The AAPS Journal
|September 26, 2013
Summary
Harmonizing terminology for complex drugs like biologicals and non-biological complex drugs is crucial. This article proposes globally accepted terms to clarify regulatory frameworks for market introduction and reimbursement.
Area of Science:
- Pharmaceutical Sciences
- Regulatory Affairs
- Drug Development
Background:
- Regulatory frameworks for complex drugs, including biologicals and non-biological complex drugs, are under active development.
- Inconsistent terminology across regions complicates market introduction and reimbursement processes for these advanced therapies.
Purpose of the Study:
- To analyze and clarify the meaning of key terms related to (non-) biological complex drugs in major global regions (Europe, USA, WHO).
- To propose a harmonized, globally accepted terminology for (non-) biological complex drugs to ensure consistent interpretation of regulatory documents.
Main Methods:
- Comparative analysis of terminology used in regulatory documents and guidance from Europe, the USA, and the World Health Organization (WHO).
- Literature review and expert consultation to identify discrepancies and propose standardized definitions.
Main Results:
- Significant variations in terminology for complex drugs were identified across different regulatory jurisdictions.
- A proposal for a unified global terminology for (non-) biological complex drugs has been developed, addressing current ambiguities.
Conclusions:
- Establishing a globally harmonized terminology is essential for clear communication and consistent regulation of complex drugs.
- The proposed terminology aims to facilitate smoother market access and equitable reimbursement for biologicals and non-biological complex drugs worldwide.
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