Portela Maria Conceição, Sinogas Carlos, Almeida Fernando Albuquerque, Baptista-Leite Ricardo, Castro-Caldas Alexandre
Instituto de Ciências da Saúde. Universidade Católica Portuguesa. Lisboa. Portugal.
Acompanhamento Farmacoterapêutico, Lda. Pavia. Portugal. Departamento de Biologia. Escola de Ciências e Tecnologia. Universidade de Évora. Évora. Portugal.
Acta Med Port. 2017 Mar 31;30(3):205-212. doi: 10.20344/amp.8079.
Biological and biosimilar medicinal products have specific characteristics that call for a closer monitoring of their safety profile. Since the current legal framework stems from both European and national regulations, some gaps in the operational field may be expected. The goal of this paper is to identify these gaps and propose changes to the current information systems and pharmacovigilance regulations.
A qualitative analysis of current pharmacovigilance regulatory framework and supporting information system was conducted.
Current pharmacovigilance system does not seem to vouch for the safe use of biologicals and biosimilar drugs. The gaps found in reviewed materials may be attributable to their lack of specificity for biopharmaceuticals.
Biologicals therapy presents specific determinants related with the drugs, prescription, and traceability, without replication in any other segment of the pharmaceutical market. They are able to shape their safety profile.
The existing pharmacovigilance's regulatory framework should be adjusted in order to improve the safety related with biopharmaceutical therapy. Some intervention measures are proposed.
生物制品和生物类似药具有特定特性，需要对其安全性进行更密切监测。由于当前法律框架源自欧洲和国家法规，预计在实际操作领域会存在一些差距。本文旨在找出这些差距，并对现行信息系统和药物警戒法规提出改进建议。
对现行药物警戒监管框架及配套信息系统进行了定性分析。
现行药物警戒系统似乎无法确保生物制品和生物类似药的安全使用。审查材料中发现的差距可能归因于它们对生物制药缺乏特异性。
生物制品治疗具有与药物、处方和可追溯性相关的特定决定因素，在药品市场的任何其他领域都不存在。它们能够塑造自身的安全性。
应调整现行药物警戒监管框架，以提高生物制药治疗的安全性。提出了一些干预措施。
