EU Product Registration Ep.9

If one were to express the biggest challenge in entering the European pharmaceutical market in one word, would it be GXP compliance? Or is it the competition from competitors with similar products? Perhaps it’s the cost or the complexity of the market. Alternatively, could it be the timing to launch? 

We should consider the complexity of the market as the biggest challenge. Personally, being a European company and having worked in regulatory affairs, we find it relatively easy from our perspective. We are familiar with the European landscape, including its political aspects, and understand how it can significantly impact market entry. However, when we work on registrations in the US, Canada, and Switzerland, we realize how Europe is quite complex. With more than 50 competent authorities and 24 languages across all member states, it presents a significant challenge. 

So what is the biggest challenge, particularly in batch release? 

Definitely GMP compliance. GXP compliance, in general, tends to be an issue because it is commonly underestimated, with the focus often placed solely on the submission of the dossier, which is indeed important. However, alongside that, all activities related to the product must be conducted in an EU GMP compliant manner. This often requires significant investment in resources, not just in equipment for production, but also in personnel to establish the necessary quality systems required to maintain a healthy and compliant GMP system.