Abstract
Purpose
The purpose of this study was to investigate what kind of regulatory affairs tasks is outsourced in the pharmaceutical industry and what are the reasons for outsourcing in the EU countries.
Methods
The study was conducted as an e-mail survey in the pharmaceutical industry in Finland, Sweden, Estonia, Germany, and Spain, focusing on those companies that undertake regulatory affairs.
Results
The survey received 71 completed responses out of 147, a response rate of 48 %. The most outsourced tasks were related to translations of product information texts (75 % of the respondents). The principal reason for outsourcing regulatory affairs tasks to a Contract Research Organization (CRO) was the excessively heavy workload in the company’s regulatory affairs. Also, outsourcing should be cost-effective. The fact that the CRO has experience and knowledge was seen as a very important requirement when choosing the CRO partner. Personal, individual contacts were mentioned in many of the open-ended responses as an essential criterion in the selection of the CRO.
Conclusions
This survey indicated that outsourcing in regulatory affairs will continue. The quality of the CRO has a significant role when the companies select their partner. The CRO has to assure uniform quality of their personnel knowledge and skills in regulatory affairs, i.e., when the person in charge of the outsourced task changes in the CRO. Practically all product development steps can be outsourced by hiring local and multinational CROs. The companies should plan the outsourcing carefully and compare possible CROs even if the company has no plans to outsource at present.
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The authors declare that they have no conflict of interest.
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Gummerus, A., Airaksinen, M., Bengtström, M. et al. Outsourcing of Regulatory Affairs Tasks in Pharmaceutical Companies—Why and What?. J Pharm Innov 11, 46–52 (2016). https://doi.org/10.1007/s12247-015-9235-4
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DOI: https://doi.org/10.1007/s12247-015-9235-4