7 December, 2023

Navigating Pharmacovigilance: Guide for Biotechs Launching in Europe and the USA

Are you a biotech preparing to launch your products in Europe and the USA? Congratulations on reaching this significant milestone!

As you embark on this journey, we recognize the importance of navigating the complex landscape of pharmacovigilance (PV) with precision. In this guide, we will delve into crucial considerations for both the European Economic Area (EEA) and the United States to help you establish robust PV systems and ensure compliance.


  1. Conducting a Gap Analysis: The Foundation for Success in Drug Safety Monitoring

Initiate a thorough gap analysis at an early stage to identify disparities between your existing processes and the drug safety monitoring requirements in the EEA and the USA. Consider seeking the guidance of a consultant during the pre-application phase to gain valuable insights, facilitating a proactive approach to address any deficiencies.

  1. Building Strategic Foundations: Ensuring Timely Preparation of PSMF and RMP

Prioritize the preparation of a comprehensive Risk Management Plan (RMP) and Pharmacovigilance System Master File (PSMF) for submission to regulatory authorities. These documents lay the groundwork for effective post-marketing surveillance. Regulatory bodies, such as the European Medicines Agency (EMA), require the submission of an RMP and may request your PSMF as part of your Marketing Authorization Application (MAA). During the preparation of these documents, consider factors related to the commercialization phase, including partnerships, distributors, labelling, and other pertinent details. It is imperative to allocate sufficient time for the preparation of the PSMF and RMP, as gathering data from various stakeholders may be time-consuming.

  1. Global Safety Database Set-Up or Configuration: Streamlining for Post-Marketing Surveillance

Configure or establish the safety database based on clinical trial implementation to ensure compliance with post-marketing surveillance requirements. When implementing or configuring the safety database, take into account considerations for combination products and adhere to the FDA submission requirements in DTD 2.2 format.

  1. Quality Management System (QMS): Establishing a Solid Foundation for Post-Authorization Compliance

Maintain a robust QMS, especially when outsourcing elements of your PV system. Clearly define roles and responsibilities within your QMS to ensure effective post-authorization compliance. It is essential to have well-defined Vendor Management procedures in place, detailing how your selected vendor will oversee the system.

  1. Nomination of EU/UK-QPPV and Considerations for the EEA: Meeting Post-Marketing Requirements

Appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) within the EU/UK, ensuring permanent availability for post-authorization requirements. The QPPV for UK Marketing Authorizations can reside and operate anywhere in the UK or the EU/EEA. Depending on the QPPV’s location, you may also require an additional person, such as a national contact residing in the UK, if your EU-based QPPV also serves the UK market.

  1. Appointment of Local Contact Person for Pharmacovigilance

National Competent Authorities within the European Union can request appointment of a national contact person for pharmacovigilance. These individuals, known by various titles, like LCPPV, LSO, LPPV, NRPPV, LPPV, QPPV share the role of representing MAHs on a country level for PV matters. Requirements vary across the countries, from request to know a local language to more stringent criteria where a local appointee holds legal responsibilities, influencing overall the MAH’s PV system. The National pharmacovigilance representative plays a crucial role in guaranteeing a company’s adherence to PV standards – this involves verifying that the company has established effective systems and procedures for gathering, documenting, reporting and addressing suspected adverse reactions.

You can find detailed requirements per country here: https://primevigilance.com/pharmacovigilance-services/local-contact-person-responsible-for-pharmacovigilance/

  1. Setting Up a Medical Information System

Establishing a robust Medical Information system is essential for providing accurate and timely information to your customers. Tailor the Medical Information database to your product portfolio, incorporating the latest scientific data, safety information, and regulatory updates. Additionally, create communication channels such as call centres, email boxes, live chat, and self-service portals to facilitate efficient interaction. Craft your Medical Information response content not only to meet regulatory standards but also to engage and educate your audience. Managing a call centre effectively requires more than just technology; it necessitates a well-trained and culturally aware team with a solid foundation in life sciences.

  1. Aggregate Safety Reports: Meeting Post-Marketing Requirements in the USA

Post-Approval Drug Experience Reports (PADERs) are aggregate safety reports submitted to the FDA for products approved for marketing in the US. You will need to submit PADERs for the first time after receiving Marketing Authorization Approval (MAA). For the initial three years post-MAA, quarterly PADER submissions within 30 days of the quarter’s close and annual submissions within 60 days of the US approval date are required. When transitioning from Periodic Safety Update Reports (PSUR) to Periodic Benefit-Risk Evaluation Reports (PBRER), the marketing authorization holder can proceed without modifying the new waiver application unless there’s a change in the reporting frequency of the Data Lock Point (DLP).


In conclusion, launching your products in new markets presents unique challenges, especially in the realm of pharmacovigilance. By proactively addressing post-marketing requirements, drug safety monitoring, and compliance considerations, biotech companies can navigate this journey with confidence. Remember that continuous vigilance and adaptation are key to ensuring the safety and success of your pharmaceutical products.


Primevigilance is the leading pharmacovigilance service provider delivering global solutions for both clinical safety and post-marketing PV and Medical Information (MI). With a global presence, a team of 900+ professionals, access to top regulatory experts, and key opinion leaders, we offer extensive experience in various therapeutic areas and regulatory landscapes.

Do not hesitate to reach out to PrimeVigilance for personalized support throughout your post-marketing journey. Get in touch with us at www.primevigilance.com.

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