Import testing turned into an unnecessary limitation of patient access to medicines as risks are managed effectively

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.