Foreword: Importation testing: an unnecessary burden on industry?
One of the principle objectives of the Internal Conference on Harmonisation (ICH) initiatives was to introduce harmonised approaches, prevent duplication and eliminate wasteful and unnecessary testing. Although good progress was made initially, there was evidence that certain countries, regions and trans-national organisations were unhappy with some of the proposed harmonised guidances, as exemplified by the withdrawal of ICH Q1F.
Another area that has prompted concern within industry is the proliferation of importation testing or in-country testing. A recent article highlighted some of the practices and related issues. Based on a survey of six multi-national pharmaceutical companies under the auspices of International Federation of Pharmaceutical Manufacturers and Associations, a total of 184 data sets covering 149 countries were collected over a three-month period in 20142. The survey assessed import testing and other categories of country-specific re-testing, e.g., post-market surveillance or waivers. The participating companies reported that 18,616 re-tests were requested per annum and this extra testing resulted in one additional batch failure, i.e., a rejection rate of 0.005%2. This substantiates the view that this additional testing is not enhancing quality or safety benefits to the end user, provided that good distribution practice (GDP) and an appropriate control strategy is implemented throughout the entire supply chain.
It was estimated that the average delay caused by this additional testing was four weeks in duration, with a maximum delay of 22 weeks experienced in China. Some countries, such as China, stipulate the minimum remaining shelf-life (RSL) should be 12 months, hence a five-month-or-greater delay can significantly impact on the RSL, particularly for biologicals. In addition, the safety implications for these additional test samples need to be understood. Security/tamperevident seals need to be breached to allow for additional testing, which increases the risk of batch contamination and/or samples being lost or diverted (increasing counterfeit concerns). In contrast, all of these risks are significantly reduced when robust GDPs are in place…