Your Trusted Partner for Pharmacovigilance Support in Hungary
Hungary offers an array of specialized pharmacovigilance services through highly experienced local providers that adhere to EU regulations while upholding patient safety. The National Centre for Public Health and Pharmacy (NNGYK), successor of OGYEI, serves as Hungary's central authority regulating pharmaceutical regulation. From clinical trial supervision to postmarket surveillance, its comprehensive role ensures all medicinal products maintain high levels of safety, efficacy, and quality standards while aligning national practices with EU regulations and meeting country-specific needs.
At DDReg, we provide pharmacovigilance services in Hungary to ensure compliance, maintain patient safety, and successfully navigate regulatory complexity with confidence.
Pharmacovigilance Framework in Hungary
This framework defines the legal, regulatory and procedural rules regarding monitoring medicinal products in Hungary according to EU legislation.
This system is managed and overseen by the National Centre for Public Health and Pharmacy (NNGYK), previously OGYEI, and includes:
- Mandatory reporting of adverse drug reactions by Marketing Authorization Holders (MAHs).
- Literature Monitoring, electronic submission protocols through EudraVigilance (EVPM/EVWEB), implementation of Risk Management Plans (RMPs), as well as selection and appointment of Qualified Person for Pharmacovigilance (QPPV), as required, as well as identification and implementation of local contacts, pharmacovigilance representatives are key activities involved with Pharmacovigilance activities.
- Clarifying responsibilities associated with postmarketing surveillance and pharmacovigilance inspections. This framework incorporates EU directives and Good Pharmacovigilance Practices (GVP) modules, providing legal compliance for human and veterinary medicinal products alike. With particular attention given to safeguarding public health through structured monitoring and risk management processes.
Local Pharmacovigilance Requirements in Hungary
This term refers to any activities, operations, or support drug safety services provide for MAHs that seek compliance with their respective pharmacovigilance framework.
- Pharma-Regist Ltd: With over three decades of experience in Hungary's pharmacovigilance industry, the company provides clinical trials, regulatory consulting, and medical device vigilance services. Its offerings include adverse event collection, PSUR submission, EudraVigilance registration, pharmacovigilance training, and consultation for pre- and post-marketing safety monitoring, along with quality system implementation.
- Grove: Provides fully outsourced local pharmacovigilance services, including QPPV reporting, 24/7 adverse event reporting, end-to-end case processing, system quality checks, medical literature monitoring (MLM), client pharmacovigilance training, pharmaceutical product support, and medical device support services.
- Inparibus Kft: A leading domestic pharmacovigilance consultancy in Hungary since 2001, offering local representation for foreign companies along with medical literature monitoring and pharmacovigilance support.
- SGS Hungary: Its multilingual team of MDs, PhDs, and pharmaceutical scientists delivers comprehensive pharmacovigilance services, including ICSR management, literature searches, safety reports (DSUR, PSUR, PADER, PAER, and PBRER), clinical overviews, and benefit-risk analyses to ensure regulatory compliance throughout product development.
- Insuvia Hungary: Provides pharmacovigilance and regulatory affairs services tailored to EU and Hungarian regulations, helping companies maintain market compliance and efficiently navigate the regulatory landscape.
- QPPV.hu: Offers EU/EEA QPPV and Local Person Responsible for Pharmacovigilance (LPPV/LSRP) services, complete pharmacovigilance system infrastructure for MAHs and distributors, adverse event processing, medical information services, regulatory compliance support, and training to build in-house pharmacovigilance expertise.
Drug Approval Process in Hungary
Preclinical Studies, both in-vitro and in-vivo, evaluate toxicology, pharmacology, pharmacokinetics and dosage for each product prior to human trials. Their goal is to establish safety and potential efficacy before human trials begin.
These clinical trials occur over three phases.
- Phase I includes small volunteer groups for safety and dosage evaluation.
- Phase II includes medium-sized groups who evaluate efficacy and side effects before transitioning to larger-scale testing; this phase confirms efficacy while monitoring adverse events.
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Phase III includes large-scale testing; it confirms efficacy and monitors adverse events.
Clinical trials require ethical review from appropriate committees: National Ethics Committee for Clinical Pharmacology (KFEB), Human Reproduction Ethics Board (HRB), and National Scientific and Ethical Committee (TUKEB). Informed consent and strict compliance with ethical standards must be observed by researchers conducting studies
Marketing Authorization Application (MAA)
Submittal of complete preclinical, clinical, manufacturing and labeling data for evaluation by NNGYK for scientific assessment, as well as risk management/pharmacovigilance review, before authorization pathway selection is decided.
Authorization Pathways
Submission of comprehensive preclinical, clinical and manufacturing labeling data on preclinical, clinical and manufacturing labels, etc., for evaluation by NNGYK.
Centralized Procedure (CP)
Approved by both EMA and the European Commission with automatic applicability in Hungary.
Decentralized Procedure / Mutual Recognition Procedure (MRP)
Multi-state authorization with Hungary as Reference Member State or Concerned Member State.
Post Market Surveillance
Ongoing Pharmacovigilance is mandatory with mandatory reporting requirements within 15 days for serious adverse events that require post market surveillance.
NNGYK provides Periodic Safety Update Reports (PSURs) on less severe adverse events. They monitor manufacturing standards (GMP), distribution (GDP), and compliance with approved variations.
Enforcement and Compliance: They conduct inspections and audits at manufacturing, storage, and distribution facilities as part of enforcement and compliance activities. Hungary has an active history of regulatory enforcement, with fines for noncompliant cases reaching hundreds of millions HUF (EUR1.3 million).
Additional Roles of OGYEI / NNGYK: Provide advice on regulatory guidelines and scientific matters. Conduct public health nutrition and food safety projects. Maintain national pharmacopeia’s, formulary standards and educational activities. Coordinate with international organizations like EMA, WHO, EDQM, OECD or other bodies.
Lifecycle Management:
- Once an authority body has given an approval it then oversees:
- Modification and renewal of marketing authorization.
- Label updates and product information maintenance.
- Implementation of new EU directives and safety measures.
Our Pharmacovigilance Services in Hungary
DDReg provides comprehensive, scalable, and inspection-ready drug safety services in Hungary, ensuring compliance with CNPM requirements and global pharmacovigilance standards.
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Individual Case Safety Report (ICSR) Management
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Aggregate Reporting & Safety Writing
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Signal Detection & Risk Management
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Local Pharmacovigilance Compliance in Finland
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Literature Screening & Safety Intelligence
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Pharmacovigilance Consulting Services in Hungary
Why Choose DDReg as Your Pharmacovigilance Company in Hungary?
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Strong Local Compliance Expertise
We understand CNPM requirements, Hungarian PV guidelines, and local regulatory expectations.
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Global Standards, Local Execution
Our pharmacovigilance systems align with WHO and international best practices while ensuring local compliance.
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End-to-End Lifecycle Support
We manage pharmacovigilance across the entire product lifecycle—from clinical development to post-marketing surveillance.
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Inspection-Ready Systems
We ensure your PV system is always prepared for CNPM audits and inspections.
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Technology-Driven Efficiency
Advanced safety databases and automation tools enhance accuracy, compliance, and traceability.
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