Import testing of medicines unnecessarily limits patient access to medicines
What is it about?
Import testing of medicines is performed in the middle of the legitimate supply chain when a product enters a country. Risks (e.g., counterfeits or substandard products), however, occur later: in the illegitimate supply chain and in the trade within a country. This article presents risk assessments demonstrating that product quality is continuously controlled. Hence, if manufacturers comply with the widely harmonized Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs), 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.
Why is it important?
In many cases, import testing does not protect patients, but unnecessarily consumes time and a significant number of product samples, which cannot be supplied to patient. As a consequence, it introduces risks to access of medicines and reduces the remaining shelf life time of medicines driving possible drug shortage.