Bringing a product to market in the EU: PV considerations for non-EU companies
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Monica Buchberger, Ph.D.
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Stephen Sun, MD, MPH
When biopharmaceutical companies outside the European Union look to bring their products to that major market, they confront a very different regulatory framework. Typically, they are accustomed to working with one regulatory agency, such as the Food and Drug Administration (FDA) or Pharmaceuticals and Medical Devices Agency (PMDA), and often assume the EU will be similarly straightforward. What they often don’t understand is the complex nature of safety reporting within the European market.
While their product might receive centralized marketing approval from the European Medicines Agency (EMA), local safety requirements can vary across the 30 countries of the EU and European Economic Area (EEA), since each country has its own regulatory agency [1]:
EU law therefore requires each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. The overall EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission. In some Member States, regional centres are in place under the coordination of the national competent authority.
Commercial success in this important market thus requires a cautious appreciation and respect for such complexity.
Role of the QPPV
The QPPV is the owner of, and therefore accountable and personally liable for, the PV system at the EU level. This person is responsible for ensuring that the marketing authorization holder has a functional and compliant PV system. The QPPV must have an overview of all PV activities, processes, and safety profiles of each product and always be available to the competent authorities.
A Local/National Contact Person is not mandatory in every EU Member State, since some countries accept PV responsibilities being covered by another Member State. But, where it is mandatory, that national contact person has responsibility for PV activities in that country and acts as contact point, again, always being available to NCAs5.
The US role most closely aligned to that of the QPPV is a head of safety or regulatory, a role assigned to the sponsor rather than an individual.
Strategies for market entry
Companies looking to enter the EU market are advised to identify and embed the additional time and costs of safety compliance into budgets and marketing strategies. Robust communication between the regulatory and commercial arms of any company is key to successfully navigating pathways for marketing authorization.
Some companies may wish to adopt a staged approach to entering the EU, starting with a few countries at a time. Such companies may also wish to use the MRP or DCP pathway to avoid approval in countries where the products are not being sold, thereby avoiding the accrual of costs for mandatory regulatory compliance in a country that is not generating sales revenue.
Staying ahead of an evolving landscape
Companies based outside of the EU and seeking to take a product to market in the EU are advised to identify strategies that successfully account for the additional complexities of national and European compliance to drug safety reporting. Irrespective of whether the PV system is outsourced or in-house, the ultimate responsibility for compliance remains with the MAH.
Companies will need proper surveillance and an acute awareness of the evolving safety landscape to stay compliant with changing regulations. External experts can help US companies to identify local requirements and devise comprehensive marketing strategies that can account for market differences.
- Pharmacovigilance: overview, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview
- Medicines Approval System, HMA. https://www.hma.eu/about-hma/medicines-approval-system.html
- Legal framework: Pharmacovigilance, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview/legal-framework-pharmacovigilance
- Good pharmacovigilance practices, EMA. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/pharmacovigilance-post-authorisation/good-pharmacovigilance-practices
- Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level, EMA. https://www.ema.europa.eu/en/documents/other/information-member-states-requirement-nomination-pharmacovigilance-phv-contact-person-national-level_en.pdf
- Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, FDA. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-pharmacovigilance-practices-and-pharmacoepidemiologic-assessment
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure. https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european-medicines-agency-post-authorisation-procedural-advice-users-centralised-procedure_en.pdf
- Regulation (EU) 2019/5 of the European Parliament and of the Council. https://eur-lex.europa.eu/eli/reg/2019/5/oj
Disclaimer: This blog is intended to communicate PharmaLex’s capabilities which are backed by the author’s expertise. However, PharmaLex US Corporation and its parent, Cencora, Inc., strongly encourage readers to review the references provided with this article and all available information related to the topics mentioned herein and to rely on their own experience and expertise in making decisions related thereto as the article may contain certain marketing statements and does not constitute legal advice.
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