Affiliations: [a] External Affairs, International Quality, AMGEN (Europe) GmbH, Switzerland | [b] Global Quality Manager In-Country Testing, F. Hoffmann-La Roche Ltd., Basel, Switzerland
Correspondence:
[*]
Corresponding author: Stephan K. Rönninger, External Affairs, International Quality, AMGEN (Europe) GmbH, Dammstrasse 23, CH-6301 Zug, Switzerland. Tel.: +41 41 369 2521; Fax: +41 41 369 0200; E-mail:stephan.roenninger@amgen.com
Abstract: The presented facts suggest that import testing does not protect patients.
On the contrary, it introduces potential risks to access of medicines and
reduces the remaining shelf life time of medicines driving possible drug
shortage. In the absence of data proving the evidence that import testing is
decreasing risk to patients, if manufacturers comply with the evolving Good
Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs)
regulations, including secure supply chains with documented controls, import
testing should be waived. In these cases, importing country's Health
Authorities should be confident the product is safe, of high quality, and in
compliance with registered specifications. This article presents risk assessments demonstrating that product quality is
continuously controlled. Moreover, import testing does not detect
counterfeit or substandard products nor reduces the additional risks related
to local distribution channels, as testing occurs at the point of entry into
a country.
Keywords: Import testing, importation, testing, Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), risk assessment
