Links
This page features links to healthcare organizations and legislation governing the sector.
Research Organizations of Finnish University Hospitals
Authorities, Associations and Organizations
Insurance Institutions for Clinical and Drug Trials
Data Protection Authorities
Publication Registers Approved by ICMJE (for research carried out in the EU)
Provisions and Guidelines
Regulations Regarding Medical Research
- Medical Research Act (488/1999) and amendments (295/2004, 794/2010 ja 143/2015)
- Medical Research Decree (986/1999) and amendment (313/2004) and amendment (65/2016)
- Decree on compensation to research subjects and ethics committees (1390/2006)
- EU Clinical Trials Directive (2001/20/EC)
- EU Medicinal Products
- Directive (2001/83/EC) and amendment (2003/63/EC)
- EU Good Clinical Practice Directive (2005/28/EC)
- EU Paediatric Medicines Regulation (EC 1901/2006) and amending Regulation (EC 1902/2006)
- EU Clinical Trials Regulation (EU 536/2014)
- EU Medical Devices Regulation (EU 745/2017)
- EU In Vitro Diagnostic Medical Devices Regulation (EU 746/2017)
- Biobank Act (688/2012)
- Current regulations issued by Fimea, e.g., Clinical trials on medicinal products (2/2012)
- Act on the Status and Rights of Patients (785/1992) and as amended
- Patient Injuries Act (585/1986) and as amended
- Medicines Act (395/1987) and as amended
- Medicines Decree (693/1987)
- Radiation Safety Act (592/1991)
- Child Welfare Act (417/2007)
- Constitution Act of Finland (731/1999) and as amended
- Act on Child Custody and Right of Access (361/1983)
- Personal Data Act (523/1999)
- Act on the Openness of Government Activities (621/1999)
- Decree on National Personal Data Registers Kept under the Health Care System (774/1989) and as amended
- Medical Device Act (719/2021)
- Act on the Medical Use of Human Organs, Tissues and Cells (101/2001) and its amendment (547/2007)
- Decree on the Medical Use of Human Organs, Tissues and Cells (1302/2007)
- Gene Technology Act (377/1995) and its amendment (847/2004)
- Decree on Gene Technology (928/2004)
Medical Databases and Research Publication Registers
Ethical Guidelines and Declarations
- World Medical Association’s (WMA) Declaration of Helsinki (DoH) (2013)
- Guideline E11 on clinical investigation of medicinal products in the pediatric population, International Working Group on Harmonisation (2001)
- Council of Europe’s Convention on
- Human Rights and Biomedicine ETS 164 (1997)
- United Nations’ Universal Declaration of Human Rights (1948)