Pharmacovigilance requirements in Europe are primarily governed by the European Medicines Agency (EMA) through the EU Regulation on Pharmacovigilance (Regulation (EU) No 1235/2010). However, some national differences in implementing and enforcing these requirements may exist. These differences could include Reporting timelines and formats, local adverse event reporting, documentation and record-keeping requirements, or inspections and audits. Therefore, it is essential to be aware of and comply with the national requirements and EU-wide regulations. This article explores national differences in pharmacovigilance requirements in Europe.
What is the EMA’s role in Pharmacovigilance?
The European Medicines Agency (EMA) is a centralized regulatory body for human and veterinary medicines in the European Union (EU). In the area of Pharmacovigilance, the EMA’s role is to:
- Develop and implement EU-wide regulations for Pharmacovigilance
- Oversee and coordinate pharmacovigilance activities across the EU
- Evaluate and assess safety data for human and veterinary medicines
- Provide scientific and technical guidance to national regulatory authorities
- Ensure the protection of public health by continuously monitoring the safety of medicines
- Promote the effective and efficient use of pharmacovigilance information
- Facilitate the exchange of pharmacovigilance information between national regulatory authorities and industry.
The EMA’s pharmacovigilance activities are designed to promote the safe and effective use of medicines in the EU and to protect public health by continuously monitoring the safety of medicines on the market.
The EMA works closely with national regulatory authorities, healthcare professionals, and the industry to ensure that the latest pharmacovigilance information is available and used effectively.
How come there are differences between national pharmacovigilance requirements?
Although the European Medicines Agency (EMA) sets EU-wide regulations for Pharmacovigilance, there can still be differences in requirements between countries due to the following reasons:
- National legislation: EU regulations serve as a minimum standard, and countries can impose additional requirements within their national legislation to further protect public health.
- Different interpretations of EU regulations: EU regulations can be interpreted differently by national authorities, leading to variations in requirements between countries.
- Specific national needs and priorities: Different countries may have specific national priorities and needs not addressed by EU regulations, leading to additional requirements for Pharmacovigilance.
- National regulations for healthcare and medicines: Different countries may have unique regulations for healthcare and medicines, which can influence pharmacovigilance requirements.
These differences can pose challenges for companies seeking to operate in multiple countries within the EU, as they must be aware of and comply with the specific requirements of each country.
National Pharmacovigilance requirements throughout Europe
Below we give links to guidance on additional requirements for Pharmacovigilance beyond the EU-wide regulations set by the European Medicines Agency (EMA). Companies need to be aware of and comply with these additional requirements to ensure effective Pharmacovigilance in France.
Pharmacovigilance in Germany
In Germany, The German Federal Institute for Drugs and Medical Devices (BfArM), and more specifically, a specialized Pharmacovigilance Division, is responsible for Pharmacovigilance requirements.
You can find more information on the BfArM website.
Pharmacovigilance in France
You can find more information on national pharmacovigilance requirements for France on the French National Agency for Medicines and Health Products Safety (ANSM) website.
You can find more information on the ANSM website.
Pharmacovigilance in Italy
In Italy, AIFA promotes active pharmacovigilance programmes and studies to increase knowledge on medicines, better define the safety profile in relation to their use, improve how they are used, and establish a safety profile that best corresponds to clinical practice and more realistically describes the characteristics of patients undergoing treatment.
You can find more information on the AIFA website.
Pharmacovigilance in the Netherlands
The Netherlands provides national legislation to aid the quality and safety monitoring of drug products laid down in the Medicins Act.
Lareb is the Dutch National Institute for Health and the Environment’s Center for Adverse Reactions. It is a national pharmacovigilance centre in the Netherlands that collects and evaluates information on adverse reactions to medicines and medical devices. Lareb acts as a central reporting point for healthcare professionals, patients, and consumers and provides valuable data and insights to support pharmacovigilance activities in the Netherlands. Lareb also raises awareness of Pharmacovigilance and promotes the safe use of medicines and medical devices in the Netherlands.
You can find more information on the Lareb website.
Pharmacovigilance in the UK
To no surprise, Brexit had a significant impact on pharmacovigilance requirements in the UK. After the UK’s departure from the European Union (EU), the UK is no longer subject to EU-wide regulations on Pharmacovigilance set by the European Medicines Agency (EMA).
Instead, the UK has established its national pharmacovigilance requirements. In the UK, Pharmacovigilance is primarily the responsibility of the Medicines and Healthcare products Regulatory Agency (MHRA).
You can find guidance and some helpful webinars on the MHRA website.
The European Medicines Agency (EMA) and the European Commission (EC) also provided guidance for pharmaceutical companies to help prepare for Brexit.
You can find the guidance on the EMA website.
The MHRA works closely with the European Medicines Agency (EMA) and other national regulatory authorities to ensure that pharmacovigilance information is effectively shared and used to promote the safe and effective use of medicines across the EU. Companies operating in the UK must comply with pharmacovigilance regulations and report adverse reactions to the MHRA.
How can you gain more insight into the national differences in Pharmacovigilance in Europe?
Gaining more insight into the national differences in Pharmacovigilance requirements in Europe is critical for ensuring compliance with regulations, protecting public health, and promoting the safe and effective use of medicines. How can you gain more insights?
As we mentioned above, it’s pivotal to consult official regulatory guidance. National regulatory agencies provide official guidance on their respective country’s pharmacovigilance requirements; ignoring these would be a significant misstep.
In addition, try these actions:
- Read academic publications: Numerous academic publications focus on Pharmacovigilance, including articles and conference proceedings that address national differences.
- Attend conferences and workshops: Conferences and workshops dedicated to Pharmacovigilance provide opportunities to network and hear directly from regulatory agencies and industry experts about national differences in pharmacovigilance requirements.
- Work with industry experts: If you need to be sure, start a conversation with an expert. For example, Biomapas’ pharmacovigilance professionals have extensive experience navigating the complexities of national pharmacovigilance requirements and can provide valuable insights and support.
Using these resources, you can gain a deeper understanding of the national differences in pharmacovigilance requirements in Europe and ensure effective compliance in your work. Finally, follow our regulatory news and updates and keep up-to-date with regulatory news and updates.
Building Health Literacy: The Value of Good Writing
Scientists, doctors, and health authorities often use written communication to present their research, opinions, or guidelines to the patients. While the questions they approach may be complex, the language should not. In medical documents, misinterpreted information may endanger the health and life of a patient. Thus, the main goal in medical writing is to convey the message clearly and concisely to avoid misinterpretation.
Proper Publicizing in CEECs – Path to Successful Social Media Commercials
With the growth of social media network users all over the world, there is no doubt that one of the most widely used channels for promoting is social media. Statistics show that Facebook and Instagram were used actively with more than 3.4 billion people daily by January 2020. Therefore, since medical devices and over-the-counter medicines are being more often promoted by commercials on social media nowadays, there is a greater risk of hidden or misleading advertisements.
What do you need to know while preparing RMP for EAEU and CIS region?
Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements for RMP preparation in different regions. Within this article, we will concentrate on the Eurasian Economic Union (EAEU) and identify specific conditions of EAEU countries as well as to try to understand the expectations of Competent Authorities in this region.
MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics
Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers, pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder. During the National semi-annual conference „Pharmaceutical News“, State Medicines Control Agency presented the statistics of suspected ADRs reporting in Lithuania.
Biomapas appoints Head of Global Pharmacovigilance
March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania, Switzerland, Sweden, Russia, Georgia, Ukraine and Poland, Biomapas provides services in 60+ countries across 4 continents. As a functional and full outsourcing solution provider, Biomapas continues to strengthen its international team and geographical coverage of its services globally.
What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new potentially causal association between an adverse event, beneficial response and a medical product, or a new aspect of causal association that was previously known. Usually, a signal will be relevant for all products with the same active ingredient, including the combination products. Further, let’s look more at the main steps of the safety signal management.
Local Literature Surveillance Challenges and Specifics in the EU, CIS and LATAM regions
PV legislation introduced by the European Commission in 2012 and GVP guidelines together with local requirements committed each MAH to perform literature review in countries where their products are present. Compliance with mandatory requirements and guidelines is not always a simple task when local requirements and specifics come along. In this article, we will take a closer look at these challenges and specifics for local literature surveillance in different regions as EU, CIS and LATAM.
Remaining Vigilant and Compliant after Brexit: What’s next? (Latest Updates)
On 29th March 2017 UK submitted the notification of its intention to withdraw from the EU. This means that UK will become a ‘third country’ from 30th March’19. Even though leaving the EU with a deal remains the Government’s top priority, UK drug agency is publishing a series of guidance documents for industry and other stakeholders covering the proposed arrangements for the regulation of medicines, medical devices and clinical trials, if UK leaves EU with no deal.
Harmonization of EAEU GVP: CIS is getting more vigilant than ever before
On the 6-7 March, Biomapas Pharmacovigilance Department management and team from the CIS region participated in a meeting in Minsk. It was dedicated to strengthening collaboration between the team members as well as updating knowledge on latest PV trends. We discussed the most recent releases of legislation, such as Eurasian Economic Union Good Pharmacovigilance Practice harmonization and the importance of a teamwork approach with Biomapas’ PV Project Manager CIS, Aliaksandr Bakshtanovich, MD.
