Your Trusted Partner for Pharmacovigilance Support in Finland
In Finland, the pharmacovigilance system has emerged within the European Union's regulatory framework and is overseen by the Finnish Medicines Agency (Fimea). Moreover, pharmaceutical regulations in Finland also describe various stages of a drug's lifecycle, from research and development to marketing and post-marketing surveillance. Understanding these regulatory needs is important for pharmaceutical manufacturers looking to enter the Finnish market. Compliance with Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) is essential, ensuring that all pharmaceuticals developed and marketed within Finland adhere to the highest quality standards.
Pharmacovigilance Framework in Finland
The alignment ensures compliance with all EU pharmacovigilance legislation, including Good Pharmacovigilance Practices (GVP), with fewer national deviations.
- Clinical Safety in Clinical Trials in Finland: These are governed by the EU Clinical Trials Regulation (CTR 536/2014) and necessitate approval via the Clinical Trials Information System (CTIS), and all SUSARs are reported to EudraVigilance.
- Fatal or Life-Threatening Events: Reports must be submitted within 7 calendar days.
- Other Serious Unexpected Reactions: A timeline of 15 calendar days is mandated for reporting. Additionally, Development Safety Update Reports (DSURs) must be submitted annually. All submissions are conducted electronically via the CTIS in conjunction with EudraVigilance.
- Post-Marketing Pharmacovigilance:For products post-authorization, Marketing Authorization Holders are required to establish a robust pharmacovigilance system.
Personnel and Infrastructure Requirements:
- Qualified Person for Pharmacovigilance: It is essential to appoint a qualified professional who resides within the EU.
- Pharmacovigilance System Master File: A comprehensive file documenting the pharmacovigilance system must be maintained and be readily accessible for inspection by Fimea.
Incident Reporting (ICSRs) Regarding the reporting of Individual Case Safety Reports:- Serious Adverse Reactions: Reports must be submitted within 15 calendar days.
- Non-Serious Adverse Reactions: Reporting is expected to be done within 90 calendar days. All reports must be submitted electronically to EudraVigilance, ensuring a streamlined and efficient reporting process.
- Risk Management and Periodic Reporting:
- Periodic Benefit-Risk Evaluation Reports: Marketing Authorization Holders must eventually conduct these evaluations at intervals consistent with the EU European Reference Dates (EURD) list, eventually commencing with semi-annual reports transforming to annual submissions.
- Risk Management Plans: These plans are required for new active substances, biologics, and medications assessed as high-risk.
Updated Pharmacovigilance key guidelines in Finland
Key Fimea Legislation and Guidelines implemented in 2026 include updated fee decrees, new reporting rules for medical devices, and regulatory integration of the EU AI Act.
Key changes include:
- Artificial Intelligence in Medical Devices: Fimea published guidance outlining requirements for AI-enabled medical devices, which now fall under both the EU Artificial Intelligence Regulation and the Medical Device Regulation (MDR).
- Incident Reporting: Manufacturers of medical devices must now report serious incidents using a revised form and protocol.
- Clinical Trials: New guidelines streamline national clinical trials, while amendments to health data regulations have also entered into force.
- Agency Fee Decree: A new decree on Fimea's public law fees includes new charges related to the Cybersecurity Act and the EU AI Act.
Drug Approval Process in Finland:
The process of drug approval in Finland is an important part of making sure that medications are both safe and effective at the same time. It's overseen by the Finnish Medicines Agency – Fimea and the European Medicines Agency (EMA), which work together to maintain trust in the system among regulatory professionals and healthcare policymakers.
- Authorization Steps:
- Centralized Procedure (CP): This route is important for innovative medicines, specifically biotechnology products and those targeting rare diseases. The EMA handles this process. By submitting a single application, companies can obtain marketing authorization that is valid across all EU/EEA countries, including Finland.
- Mutual Recognition Procedure (MRP): If a drug is already authorized in one EU Member State, this procedure allows other concerned Member States, such as Finland, to recognize that evaluation.
- Decentralized Procedure (DCP): This route is used for medicines that have not yet been authorized in any EU country. Finland can act as either the Reference Member State (RMS), leading the evaluation, or as a Concerned Member State (CMS).
- National Procedure: This applies to medicines intended to be marketed only in Finland. However, it is rarely used for new active substances due to the extensive integration of the EU regulatory system.
-
The Application Process: There's a vital role in having a clear understanding of how to submit applications and the expected timelines for healthcare policymakers and students. It helps them grasp the approval timeline and the necessary procedural steps.
All Marketing Authorization Applications (MAA) must be submitted in an electronic method, ideally using the Common Technical Document (CTD) method.
- Submission: Applications must be submitted through common European portals. Fimea describes that all national and mutual steps should be conducted electronically. Fimea and EMA maintain an active assessment timeline for 210 days, offering a known framework that assists healthcare policymakers and industry stakeholders in their planning. The authorization granted is valid for five years and can be renewed upon application.
- Fimea-Specific Guidance: If you're looking for information on national fees, language requirements (like package leaflets needing to be in Finnish and Swedish), or special permits for drugs that don't have marketing authorization, check out the guidelines provided by the Finnish Medicines Agency - Fimea.
- Post-Authorization & HTA: Fimea plays a vital role in post-authorization, including Health Technology Assessment (HTA). This present evaluation plays a vital role for regulatory professionals and policymakers as they assess the continued value of drugs and make reimbursement decisions.
- Post-Marketing Considerations: Even after marketing authorization is obtained, there may be delays before a drug can be prescribed or reimbursed. Fimea assesses the therapeutic and economic value of medicines, focusing particularly on new hospital-only drugs.
Clinical Trials under EU Regulation (536/2014):
In Finland, clinical trials are carried out following the EU Clinical Trials Regulation (536/2014) and the national Act on Clinical Trials of Medicinal Products. After the core introduction of the EU Clinical Trials Regulation, sponsors need to submit their trial applications electronically through a shared platform called the Clinical Trials Information System (CTIS). This system, managed by the European Medicines Agency (EMA), allows for a centralized submission process for all Member States where the trial is intended to take place. When applications are submitted, the medicinal authorities of the Member States will evaluate them at the same time. One Member State will take the lead as the reporting Member State, while the others will be referred to as concerned Member States.
Our Pharmacovigilance Services in Finland
DDReg provides comprehensive, scalable, and inspection-ready drug safety services in Finland, ensuring compliance with CNPM requirements and global pharmacovigilance standards.
-
Individual Case Safety Report (ICSR) Management
-
Aggregate Reporting & Safety Writing
-
Signal Detection & Risk Management
-
Local Pharmacovigilance Compliance in Finland
-
Literature Screening & Safety Intelligence
-
Pharmacovigilance Consulting Services in Finland
Why Choose DDReg as Your Pharmacovigilance Company in Finland?
-
Strong Local Compliance Expertise
We understand CNPM requirements, Finland PV guidelines, and local regulatory expectations.
-
Global Standards, Local Execution
Our pharmacovigilance systems align with WHO and international best practices while ensuring local compliance.
-
End-to-End Lifecycle Support
We manage pharmacovigilance across the entire product lifecycle—from clinical development to post-marketing surveillance.
-
Inspection-Ready Systems
We ensure your PV system is always prepared for CNPM audits and inspections.
-
Technology-Driven Efficiency
Advanced safety databases and automation tools enhance accuracy, compliance, and traceability.
Global Reach Explorer
Find Your Solution
Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
