alexa Values and Disadvantages of Outsourcing the Regulatory
ISSN: 2167-7689

Pharmaceutical Regulatory Affairs: Open Access
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Research Article

Values and Disadvantages of Outsourcing the Regulatory Affairs Tasks in the Pharmaceutical Industry in EU Countries

Gummerus A1*, Airaksinen M2, Bengtström M3 and Juppo A3

1Oy Medfiles Ltd., Hatanpään valtatie 26 A, 33100 Tampere, Finland

2Department of Pharmacy, University of Helsinki, Finland

3Department of Pharmacy, Abo Academy University, Finland

Corresponding Author:
Gummerus A
Oy Medfiles Ltd., Hatanpään valtatie 26 A 33100 Tampere, Finland
Tel: +358 40 7237 031
E-mail: [email protected]

Received date: March 14, 2016; Accepted date: April 12, 2016; Published date: April 15, 2016

Citation: Gummerus A, Airaksinen M, Bengtström M, Juppo A (2016) Values and Disadvantages of Outsourcing the Regulatory Affairs Tasks in the Pharmaceutical Industry in EU Countries. Pharmaceut Reg Affairs 5:161. doi:10.4172/2167-7689.1000161

Copyright: © 2016 Gummerus A, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.



Background: The purpose of this study was to determine the values and disadvantages of outsourcing regulatory affairs tasks in the pharmaceutical industry. The aim was also to study how many CROs the pharmaceutical companies outsource regulatory affairs tasks to and the duration of outsourcing partnerships between companies and CROs. Method: 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%. According to the responses, 65% of the pharmaceutical companies have outsourced tasks related to research and development over the last three to five years. Over 44% of the respondents informed that they have outsourced to one or two CROs only. One quarter of the respondents have outsourced to three to five CROs. Most (91%) of the respondents in the pharmaceutical industry strongly agree and agree on the fact that they outsource the regulatory affairs tasks because they want to obtain greater flexibility. The companies evaluated that outsourcing to CROs is expensive (strongly agree or agree 74%). Conclusion: CROs have to keep the qualitative level high and obtain flexibility towards the companies. When a company is considering outsourcing regulatory tasks, planning has to be done well in advance. The main topics to be discussed between the company and CRO before outsourcing process are the estimated costs of the outsourcing, outsourcing strategy, information flow and audittrails.


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