According to the European Federation of Pharmaceutical Industries and Associations, Europe is the second-largest pharmaceutical market in the world.
Therefore, it is not surprising that many biotech companies see distribution in the 30 countries that make up the European Economic Area (EEA) as key to their future success. However, because it takes an average of 12 years to bring a drug to market, organizations must take every precaution to avoid missteps.
In this two-part series, we’ll explore the requirements for success in the European pharmaceutical market. We’ll start with the regulatory framework, quality, compliance, and Wholesale Distribution Authorization.
Navigating the European regulatory framework
In the EEA, there are two main routes for authorizing medicines: a centralized route and a national route. The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralized marketing authorization applications (MAA). Once granted by the European Commission, the centralized marketing authorization is valid in all EEA countries.
Every regulatory submission has a lot of moving parts that are interconnected, and due to the number of regulatory agencies throughout Europe and the associated approval pathways for your product, these intricacies are further amplified. A clearly defined European regulatory strategy is a crucial component of your product’s success.
As each country has unique regulatory requirements, healthcare systems, and market dynamics, a robust post-approval launch strategy is pivotal in ensuring a successful post-approval product launch – ensuring compliance and optimizing market access.
To achieve a successful launch and meet the target date, the strategy should include the following considerations:
- Selecting target countries, considering patient population and competing products
- Artwork and consider shared pack strategies for commercial and supply chain efficiency
- Obtain local labelling exemptions, if necessary, especially for orphan medicinal products
- Ensure that promotional materials adhere to local regulations and ethical standards
- Ensure access to regulatory affairs representatives with knowledge of the country-specific regulatory requirements, such as:
- Local regulatory requirements for labelling and artwork
- Registration with local verification serialization organizations
- Procedure for data entry into local regulatory databases
- Procedure for uploading product information into local catalogues
With an experienced partner who understands the European regulatory landscape, your organization navigates a smooth path towards getting your products into the hands of patients.
In 2024, ProPharma was recognized for its regulatory and compliance excellence by CPHI Pharma.
Quality, compliance and Wholesale Distribution Authorization
Approval of the Marketing Authorization Application (MAA) covers the product's quality safety and efficacy profile. In addition to that, with 30 countries in the European Economic Area (EEA), the supply chain and distribution of medicines can get complicated.
You must also obtain a Wholesale Distribution Authorization (WDA) license from each country's competent agency to store and distribute the drug in compliance with EU-Good Distribution Practice (GDP) and any local requirements for a safe and secure supply chain.
To obtain a WDA, organizations must establish and maintain a relevant quality management system (QMS), as well as have a Responsible Person (RP) registered on the WDA. As the WDA application review can take several months, it is beneficial to partner with experienced consultants to increase the likelihood that your application approval process is smooth and right on the first try.
Read this case study to find out how our experts helped a client meet their target timeline to launch a new product in compliance with GDP regulations, including qualifying their distribution network and developing a QMS.
Our local affiliate experts in Europe are here to help
Entering the European pharmaceutical market presents immense opportunities—but also significant challenges. With complex and varied regulatory frameworks across the EEA, a one-size-fits-all approach simply won't suffice. Success demands a carefully crafted strategy that accounts for country-specific regulatory nuances, a robust post-approval launch plan, and full compliance with quality and distribution standards, such as EU-GDP.
By understanding the regulatory landscape, preparing early for Wholesale Distribution Authorization, and aligning with our experts who know the intricacies of the European market, biotech companies can significantly increase their chances of a smooth, timely, and compliant launch.
Contact us today to ensure your launch strategy aligns with European requirements.
