New ideas for EU import and batch release

The European Union (EU) has a population of about 500 million, and is one of the largest markets for pharmaceuticals in the world. But it involves certain challenges. For example, batch release of medicinal products is subject to quite restrictive requirements - especially for those manufactured outside the European Economic Area (EU import release).

The Medicines Company (MDCO) is a US pharmaceutical company that successfully brings its medication Angiox onto the European market with Diapharm's help. Anthony Flamia (Vice President of Global Manufacturing & Supply) explains the opportunities and obstacles relating to market access to Europe - and why MDCO decided to work with a service provider.

Quality management and batch release

A good legal base in Europe is necessary to obtain marketing approval for finished medicinal products in the European Union. For example, all batches of medicinal products must be checked and approved by a "Qualified Person" based in the European Union. This role is similar to that of "Responsible Pharmacist", "Head of Production" and "Head of Quality Control" in countries outside the EU. Europe also has its own requirements for pharmaceutical quality management.

If you wish to participate in the medicinal products market in the European Union, you either need to form a private company based in the EU - or ask Diapharm. As a comprehensive service provider, we take care of all the issues that need to be addressed to give our client market access in Europe.

The Medicines Company: An example of EU practice

Interview with Anthony Flammia, Vice President Global Manufacturing & Supply.

Why does the European market appeal to The Medicines Company?

Anthony Flammia: Our drug Angiox (Europe), or Angiomax (United States), is used in hospitals. It is an anticoagulation drug that is used during percutaneous coronary interventions. We identified the types of hospitals where our product would best fit, and a large proportion of them are in Europe. Therefore, the European marketplace has a particular focus for The Medicines Company.

What was the most interesting aspect in the European Regulatory System?

Anthony Flammia: In Europe, we chose the centralized filing approach for the marketing authorization application (MAA). Although there was a centralized filing approach, we still had rapporteurs and co-rapporteurs from different European countries. It proved to be okay, but it was different from what you would expect. In addition, setting up the infrastructure to be able to conduct business was a bit of a stumbling block. All the different licensing requirements beyond the MAA; the ability to import, wholesale dealer’s license, the pharmaceutical licenses for each country, manufacturing licenses, and so on. That is when we came to Diapharm, who then took on the manufacturing license part of it.

Why did The Medicines Company decide on Diapharm?

Anthony Flammia: We have the infrastructure for sales and marketing with several offices in Europe. On the manufacturing supply chain side, our model is not to build our own infrastructure, but rather to outsource with strategic partners. In the course of our implementation, we came across Diapharm as a group of people that has the extensive expertise that we could never just have on staff. It is really a highly competent and skilled partner and advisor that has solved problems for us. Not just in the initial days, but also as we go through this journey together.

What changes do you want to see in the regulatory system in Europe?

Anthony Flammia: I think a continuation of the centralized MAA approach down to pricing/reimbursement and licensing would be very helpful. It would be nice to say ‘I have one wholesaler dealer’s license for Europe, I have one pharmaceutical license, et cetera. I can operate. I don’t need individual licenses for every country.’ When we get to the packaging side and languages, I think that will probably always remain with a number of different languages spoken. That is fine to adapt to, as long as the regulatory procedures and processes are aligned, which is probably not easy to do, but it is aspirational, of course.

The Medicines Company (Nasdaq: MDCO)

The Medicines Company (www.themedicinescompany.com) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. The US-based company is publicly traded on the Nasdaq exchange under the ticker symbol MDCO. It was founded in 1996 and employs approximately 425 professionals.

Anthony Flammia is Vice President Global Manufacturing & Supply at The Medicines Company. Having experience in both consulting and executive leadership in directly managing supply chains under a variety of challenging situations, Anthony Flammia offers a unique perspective on the industry’s opportunities for growth & profit optimization.

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