Europe is considered the second most dynamic market for the pharmaceutical industry. The demand for innovative drugs is on the rise, and EU countries provide a prime opportunity for very successful launches, so long as you approach the complexity of commercializing drugs there efficiently. Here are a few pointers to help you optimize your medicinal product launch on the European market.
Adopt the Right Strategy for Your Medicinal Product Launch
The European market landscape is a fragmented one, as each member enforces its own sets of regulations in addition to the rules the EU follows. One of the key factors in any successful product launch is to either rely on dedicated on-site teams or to entrust a pharmaceutical product development partner with some of the steps. The goal is to surround yourself with experts who have an excellent grasp of the product registration and launching process.
Many US pharma companies fail to give their European teams the autonomy they need to make the right decisions for their own market while confining them to a sound overall strategy. This is because they are used to overseeing functions from a global perspective and tend to either centralize decision-making from their US headquarters or replicate all functions for every region. You should aim to build a tailored operation model to address local issues.
This is where a regulatory affairs consulting company comes in. They can help you gain access to new markets and advise you on how to adapt your own infrastructure to these new challenges. Alternatively, they can activate an external infrastructure to optimize your management and speed up your medicinal product launch.
Make Sure Your Product Is Relevant
An in-house medicinal product launch needs to be a carefully weighed-out decision. For it to make economic sense, a differentiated value proposition is essential. Europe is a demanding environment where products need to either be superior to the standard in terms of efficacy or significantly cost-effective. By addressing genuine clinical needs in the form of a strong value proposition, you can justify applying premium pricing.
Companies with limited financial resources must rely on lean commercial infrastructure and a streamlined go-to-market approach. This means that their call points should be as focused as possible and that they should learn to understand them thoroughly. Whether you wish to commercialize a product designed for a narrow specialty field or for an array of prescribers, it should meet their specific needs in a relevant way.
Follow the Steps to Obtain Your EU Marketing Authorization
In Europe, no medicinal product launch can happen without an official marketing authorization. The European Medicines Agency (EMA) centralizes these authorizations and is responsible for the scientific evaluation of applications. Although it will not give you any indications as to how you should price your product or make the right packaging decisions, it will allow you to make sure that your product is compliant with EU standards.
Several months prior to submitting your marketing authorization application, you will need to file an eligibility request so that your product can be evaluated. Then, a notification of intention to submit an application should be put through. Rapporteurs will be appointed by the Committee for Medicinal Products for Human Use and the Pharmacovigilance Risk Assessment Committee. They will carry out the scientific assessment. Pre-submission meetings may follow, and you will then need to reconfirm the date for your application.
Once you finally file the application, the EMA will review it and perform a technical validation if all is in order. Then assessments will begin, leading up to the European Commission’s decision.
To streamline the process and avoid making any mistakes, you can turn to a pharma consulting agency that will support you every step of the way.