Complexity of the supply chain throughout the EU
Another challenge faced by client companies is defining their distribution strategy and associated product requirements throughout
the distribution process. When distributing products to target markets, the drug product will face varying temperature ranges
and transit times, so careful consideration needs to be given to product packaging and distribution configurations.
Variations in country requirements for anti-counterfeiting measures also add to supply chain complexity. For example, the
French market requires drug products to have a 2D matrix barcode, incorporating the CIP code and batch and expiry details.
Meanwhile in Turkey, each individual saleable unit of drug product must also have a unique serial number, printed both in
human readable format and incorporated in a 2D code.
For a US company, the MAA submission strategy in Europe can present challenges in itself because of the different filing routes
(centralised and decentralised), and the various options and constraints that must be considered depending on the type of
product and therapeutic indication.
One of the most common pitfalls of companies moving into the EU from the US is the assumption that complying with FDA requirements
will automatically lead to European product approval. This is often not the case. Given the fact that the EU is a far larger
market than the US in terms of population, it is worth considering a development programme that meets the combined needs of
The most cost-efficient approach to drug development is to consider multi-regional or global regulatory requirements as early
as possible, thus preventing the need for several development programmes to be initiated to comply with separate regional
regulatory requirements. The key to successful global drug development is to seek endorsement and buy-in on the key aspects
of pharmaceutical and nonclinical drug development, particularly on the acceptability of clinical trial designs for pivotal
studies from the key regulatory authorities. Normally, the main aspects of clinical development packages and pivotal registration
trials that need to be aligned are in the areas of clinical endpoints, trial duration, choice of patient population and the
selection of active comparators. These deliberations may be met with differing opinions between FDA and EU regulatory authorities,
with difficult choices having to be made at the time of protocol finalisation.
Knowing the differences up front can help avoid unpleasant surprises at the product approval stage and, more importantly,
can make all the difference to the type of approach that is taken when seeking scientific advice from regulatory authorities.