Compliance & Safety

In recent years, the European Union has been working intensively on the topic of pharmacovigilance and has issued a number of legal provisions that regulate the monitoring of reportable events in connection with medicinal products. According to Article 12 (1) of Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012, which covers pharmacovigilance activities under Regulation (EC) No 726/2004 and Directive 2001/83/EC as supplemented by Directive 2010/84/EU, as well as Regulation (EU) No 1235/2010, marketing authorisation holders must systematically record all pharmacovigilance information and ensure that it is processed and stored in such a way as to enable proper reporting, evaluation and verification of the information.

The introduction of Good Pharmacovigilance Practices (GVP) by the European Medicines Agency (EMA) at the beginning of 2012, reinforced by continuous updates, has created the basis for the comprehensive collection, evaluation and monitoring of safety information on medicinal products. Marketing authorisation holders are obliged to take adequate measures to efficiently collect reports on possible side effects.

In addition, the introduction of the Medical Device Regulation (MDR) or Regulation (EU) 2017/745 in May 2017, which has been binding for all member states since May 2020, has further expanded the responsibility of medical device manufacturers to report incidents. Article 87 of the MDR emphasises the importance of reporting incidents that are directly or potentially related to medical devices. These regulations are supplemented by the MPAMIV.

evalii® helps companies meet new and evolving requirements by extracting relevant information from various digital communication channels and complying with documentation requirements. Our software solution enables you to export logs of posts and comments, including their complete messages and times, to ensure compliance with legal requirements

The German Medicinal Products Act (AMG) establishes a comprehensive framework that ensures safety in the handling of medicinal products. A central pillar of this law is the continuous monitoring of the safety of authorised medicinal products in order to strengthen the protection of patients.

According to Section 63c AMG, marketing authorisation holders are obliged to systematically record all suspected cases of serious adverse reactions of which they become aware and which have occurred in Germany or abroad and to report them to the competent authorities immediately, but within 15 days at the latest. This regulation helps to ensure that newly emerging risks or changes in the risk-benefit ratio of a medicinal product can be quickly identified and addressed.

Section 63b AMG stipulates that marketing authorisation holders are obliged to continuously monitor pharmacovigilance data. The aim is to recognise newly emerging risks, record changes to existing risks and, if necessary, make adjustments to the benefit-risk ratio of the medicinal products. In today's digital era, this monitoring obligation increasingly includes monitoring and analysing user comments on social media channels and other digital platforms in order to identify potential indications of adverse drug reactions at an early stage.

evalii® offers a tailor-made solution to meet these legal requirements efficiently and reliably. Our advanced software supports marketing authorization holders in collecting, analyzing and documenting relevant data from a variety of digital sources. With evalii® you can ensure that your pharmacovigilance activities comply with current legal requirements while strengthening the protection of public health.

The U.S. Food and Drug Administration (FDA) sets strict guidelines for monitoring the safety of drugs after they have been authorised. According to the Code of Federal Regulations Title 21, Section 314.80(b), marketing authorisation holders are required to fully investigate all reported adverse events and report them to the appropriate authorities within a maximum period of 15 days. These provisions are critical to ensure continuous evaluation of the risk-benefit balance of drugs and to protect public health.

evalii® is your reliable partner to help you effectively meet these regulatory requirements. Our advanced software solution offers extensive logging functions that allow you to fully document adverse effects from any source – whether domestic or foreign. With evalii® Collect relevant data from various digital communication channels, including social media platforms, to ensure complete and timely reporting.

The importance of proactive monitoring and reporting of adverse events cannot be overestimated. evalii® makes this task easier with automated data analysis and reporting capabilities specifically designed to meet FDA requirements. This enables marketing authorization holders to quickly identify new risks, adjust existing risk assessments, and take effective actions to protect patient safety.

In addition, evalii® companies in global pharmacovigilance compliance by providing a central platform for collecting and managing safety data from different countries. This international capacity is invaluable as the FDA also considers adverse event reports from abroad.

evalii® is committed to making FDA compliance not only doable, but also efficient. With our help, you can be confident that your pharmacovigilance practices meet the highest standards while you focus on developing and delivering safe medicines.

Japan sets the global standard in pharmacovigilance, with strict regulations overseen by the Pharmaceuticals and Medical Devices Agency (PMDA). These regulations aim to ensure patient safety by requiring the post-marketing surveillance of drugs and the reporting of adverse events. Under these regulations, marketing authorisation holders are required to set up efficient systems to collect and analyse pharmacovigilance data.

evalii® offers a comprehensive solution to meet these requirements. By using evalii® enables companies to effectively meet Japan's regulatory requirements in the area of pharmacovigilance. The platform enables data to be systematically collected and analyzed from a variety of sources, including digital communication channels. This is particularly relevant as the use of social media and other online platforms for health-related communication is increasing worldwide.

The key functions of evalii®that contribute to compliance with Japanese pharmacovigilance regulations include:

1. Automated data collection: evalii® automatically extracts relevant data from various sources, including social media, forums and other online platforms, increasing efficiency and ensuring that no relevant signal is missed.

2. Comprehensive data analysis: The platform analyses the collected data, identifies possible security signals and classifies them according to their urgency and relevance. This enables a rapid response to potential risks.

3. Compliance with reporting deadlines: evalii® helps companies meet strict deadlines for reporting adverse events to the PMDA by automating reporting and accelerating the process.

4. Meet reporting deadlines: Evalii helps organisations meet strict deadlines for reporting adverse events to the PMDA by automating reporting and speeding up the process.

By implementing evalii® Companies can not only comply with Japan's legal requirements in the area of pharmacovigilance, but also contribute to patient safety and public health. evalii® strengthens confidence in the safety monitoring of medicines and thus helps pharmaceutical companies to fulfil their obligations efficiently and effectively.

In line with China's progressive efforts to ensure drug safety and protect public health, the National Medical Products Administration (NMPA) has introduced the Good Pharmacovigilance Practices (GVP). These guidelines, which have been in force since 1 December 2021, provide a comprehensive framework for the monitoring, identification, evaluation and control of adverse drug reactions (ADRs).

The GVP in China comprises nine chapters covering a wide range of aspects of pharmacovigilance, from general principles and quality management to human resources and risk identification, assessment and control. A key element of these regulations is the establishment of an effective pharmacovigilance system by marketing authorization holders, including the creation and updating of a Pharmacovigilance System Master File (PSMF) that contains central documentation of all relevant pharmacovigilance activities and information.

Marketing authorization holders are also required to collect suspected adverse drug reactions from various sources and report this information according to national requirements. This includes submitting Individual Case Safety Reports (ICSRs) to the National Drug ADR System. In addition, marketing authorization holders must prepare periodic safety update reports (PSURs) to evaluate the safety information collected.

To comply with these extensive requirements, the evalii® Services can be invaluable. evalii® could support companies in implementing and managing the required processes and systems, for example by assisting with the collection and analysis of safety data, the preparation of PSURs and efficient communication with regulators. This support can be particularly beneficial for companies faced with the complexity of complying with GVP guidelines while ensuring the protection of patient safety.

Given the importance and scope of pharmacovigilance activities in China, professional support such as that provided by evalii® not only a question of compliance, but also a crucial factor for effective risk management and patient safety in one of the largest pharmaceutical markets in the world.

In line with efforts to ensure the safety of medicines after marketing authorization, Canada has implemented a comprehensive system of pharmacovigilance. This system, led by Health Canada, is based on Good Pharmacovigilance Practices (GVP), which provide detailed guidelines for the reporting of adverse drug reactions (ADRs). Marketing authorization holders and importers are required to establish effective systems and procedures for the receipt, handling, assessment and reporting of ADRs to ensure effective ADR reporting within 15 days of receipt. This includes both domestic serious expected and unexpected ADRs and foreign serious unexpected ADRs, as well as any follow-up information for initial cases.

In addition, a qualified health professional must undertake the evaluation and assessment of ADR reports. This includes establishing four minimum criteria for submitting a case, identifying key personnel responsible for forwarding ADR reports to Health Canada, and establishing procedures for collecting and filing complaints and ADRs.

For companies operating in the Canadian market, evalii® a comprehensive solution that supports compliance with these complex and detailed requirements. Through automated data collection, efficient data analysis and simplified reporting, evalii® help navigate the compliance landscape by ensuring that all relevant ADRs are reported to Health Canada in a timely manner and in accordance with regulatory requirements.

These strict regulations reflect Canada’s commitment to ensuring the safety and effectiveness of medicines through a robust pharmacovigilance system that protects patient health. Companies that evalii® can benefit from simplified compliance with these regulations, while helping to improve drug safety and increase confidence in health products in the Canadian market.

Medical devices cover a wide range of products, from simple bandages to complex implantable devices and diagnostic equipment. Due to this diversity and the different risk profiles, a robust post-market surveillance and evaluation system is essential. This includes the systematic collection and analysis of data on the performance and safety of products in real-world use.

Key components of pharmacovigilance for medical devices

1. Reporting of incidents: An essential pillar of vigilance is the obligation to report safety-relevant incidents. This includes all events that have led or could lead to a serious risk to the health of patients, users or third parties. Prompt reporting of such incidents enables manufacturers and regulatory authorities to identify potential risks and take appropriate action.

2. Field Safety Corrective Actions (FSCA) and Field Safety Notices (FSN): When a risk is identified, manufacturers may be required to take corrective action to minimize the risk. These measures are usually communicated via an FSN, which is sent to all affected product users.

3. Post-Market Surveillance (PMS): PMS includes all activities that manufacturers carry out to continuously collect and evaluate information on the safety and efficacy of their medical devices. This includes monitoring market feedback, analyzing incidents and conducting Post-Market Clinical Follow-Up (PMCF) studies.

4. Risk management: Risk management processes are of central importance throughout the entire life cycle of a medical device. This includes the identification and assessment of risks, the implementation of risk mitigation measures and the continuous monitoring of the effectiveness of these measures.

5. Clinical evaluation and Post-Market Clinical Follow-Up (PMCF): To ensure the long-term safety and performance of medical devices, manufacturers must collect and evaluate clinical data not only before market launch, but also after approval.

Importance of international cooperation

The globalization of the medical device market requires increased international cooperation and harmonization of regulatory requirements. Initiatives such as the International Medical Device Regulators Forum (IMDRF) contribute to the development of common standards and approaches that support the effective monitoring of medical devices worldwide.

Bottom line

Pharmacovigilance for medical devices is a dynamic and complex area that requires close collaboration between manufacturers, regulators, healthcare providers and patients. By implementing effective PMS and vigilance systems, risks can be minimized and the safety and efficacy of medical devices can be continuously improved for the benefit of patients worldwide.