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.
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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.
Perspectives
Several articles on import testing have been published (e.g., doi: 10.1177/2168479017701980), suggesting that this practice is outdated and redundant. This article reinforces the scientific findings with a risk assessment and provides a historical perspective.
Dr Joerg Garbe
F Hoffmann-La Roche AG
Read the Original
This page is a summary of: Import testing turned into an unnecessary limitation of patient access to medicines as risks are managed effectively, Pharmaceuticals Policy and Law, October 2016, IOS Press,
DOI: 10.3233/ppl-160439.
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Resources
Import Testing of Pharmaceutical Products Has Limited Safety Benefits and Can Add Risk to Patients
Scientific figures on import testing, suggesting that the procedure does not add significant quality or safety benefits to patients, provided that the products are uninterruptedly controlled according to the globally harmonized manufacturing, distribution, and storage standards (GMP, GDP, GSP).
Import Testing: An Outdated Practice? Opportunities for Improved Access to Safe and Efficient Medicines
Import testing does not add any significant value to the quality and safety of drugs nor reduces risks, provided the manufacturers apply good practices, e.g., Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs). The consideration to implement additional regulations does not correlate with the increasing convergence between National Regulatory Authorities (NRAs) and international harmonization, e.g., Pharmaceutical Inspection Co-Operation Scheme (PIC/S) and International Council for Harmonisation (ICH).
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