Biobank activities are regulated by various national, EU, and international laws, regulations, provisions, and standards.

 

National and EU Legislation:

 

Act XXI Of 2008 on the protection of human genetic data, the regulation of human genetic studies and research, and the operational rules for biobanks

[2008. évi XXI. törvény a humángenetikai adatok védelméről, a humángenetikai vizsgálatok és kutatások, valamint a biobankok működési szabályairól]

 

Act CLIV of 1997 on health care

[1997. évi CLIV. törvény az egészségügyről]

 

Act XLVII of 1997 on the processing and protection of health data and related personal data

[1997. évi XLVII. törvény az egészségügyi és a hozzájuk kapcsolódó személyes adatok kezeléséről és védelméről]

 

Decree 60/2003. (X.20.) of the Ministry of Health, Social, and Family Affairs on the professional minimum requirements necessary for the provision of health services

[60/2003. (X.20.) ESzCsM rendelet az egészségügyi szolgáltatások nyújtásához szükséges szakmai minimumfeltételekről]

 

Decree 73/2013. (XII. 2.) of the Ministry of Human Resources on the amendments of certain ministerial decrees related to the professional minimum requirements necessary for the provision of health services

[73/2013. (XII. 2.) EMMI rendelet az egyes egészségügyi tárgyú miniszteri rendeleteknek az egészségügyi szolgáltatás nyújtásához szükséges szakmai minimumfeltételekkel összefüggő módosításáról]

 

Decree 1/2012. (V. 31.) of the Ministry of Human Resources amending Decree 60/2003. (X. 20.) of the Ministry of Health, Social, and Family Affairs on the professional minimum requirements for the provision of health services and Decree 2/2004. (XI. 17.) of the Ministry of Health on the registration of healthcare providers and their operating licenses, as well as the healthcare professional directory (Hungarian Official Gazette, 64:10130, Thursday, May 31, 2012)

[1/2012. (V. 31.) EMMI rendelet Az egészségügyi szolgáltatások nyújtásához szükséges szakmai minimumfeltételekről szóló 60/2003. (X. 20.) ESZCSM rendelet és az egészségügyi szolgáltatók és működési engedélyük nyilvántartásáról, valamint az egészségügyi szakmai jegyzékről szóló 2/2004. (XI. 17.) EüM rendelet módosításáról (Magyar Közlöny, 64:10130, 2012. május 31., csütörtök)]

 

Decree 13/2010. (III. 31.) of the Ministry of Health amending Decree 60/2003. (X. 20.) of the Ministry of Health, Social, and Family Affairs on the professional minimum requirements for the provision of health services and Decree 48/2009. (XII. 29.) of the Ministry of Health amending Decree 60/2003. (X.20.) of the Ministry of Health, Social, and Family Affairs on the professional minimum requirements necessary for the provision of health services (Hungarian Official Gazette, 47:12115, Wednesday, March 31, 2010)

[13/2010. (III. 31.) EüM rendelet Az egészségügyi szolgáltatások nyújtásához szükséges szakmai minimumfeltételekről szóló 60/2003. (X. 20.) ESZCSM rendelet és az egészségügyi szolgáltatások nyújtásához szükséges szakmai minimumfeltételekről szóló 60/2003. (X. 20.) ESZCSM rendelet módosításáról szóló 48/2009. (XII. 29.) EüM rendelet módosításáról. (Magyar Közlöny 47:12115, 2010. március 31., szerda)]

 

Decree 26/2008. (VII. 11.) of the Ministry of Health amending Decree 60/2003. (X.20.) of the Ministry of Health, Social, and Family Affairs on the professional minimum requirements necessary for the provision of health services

[26/2008. (VII. 11.) EüM rendelet az egészségügyi szolgáltatások nyújtásához szükséges szakmai minimumfeltételekről szóló 60/2003. (X.20.) ESzCsM rendelet módosításáról]

 

Commission Directive 2006/17/EC of February 8, 2006, implementing Directive 2004/23/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells (CELEX-32006L0017)

 

Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Oviedo, 4.IV.1997 (European Treaty Series – No. 164; https://www.coe.int)

 

Council of Europe. Recommendation Rec(2006)4 of the Committee of Ministers to member states on research on biological materials of human origin. 2006.

 

EU regulations for import and export of cellular therapy products, Ineke Slaper-Cortenbach, Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA), 2006

 

European Commission, Joint Research Centre, Institute for Prospective Technological Studies. Biobanks in Europe: Prospects for Harmonisation and Networking. 2010.

 

Regulation (EU) 2016/679 of the European Parliament and of the Council on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation – GDPR)

 

Communication of the Ministry of Human Resources on the Manual of Hungarian Healthcare Standards (MEES)

 

International Laws and Guidelines:

 

UNESCO. Universal Declaration on the Human Genome and Human Rights. 1997.

 

UNESCO. Implementation of the Universal Declaration on the Human Genome and Human Rights. 1999.

 

UNESCO. Universal Declaration on Bioethics and Human Rights. 2005.

 

UNESCO. International Declaration on Human Genetic Data. 2003.

 

Human Genome Organisation, Ethical, Legal, and Social Issues Committee. Statement on DNA Sampling: Control and Access. 1998.

 

OECD. OECD Best Practice Guidelines for Biological Resource Centres. 2007.

 

OECD. OECD Guidelines on Human Biobanks and Genetic Research Databases. 2009.

 

WHO

 

ISBER. Best Practices for Repositories: Collection, Storage, Retrieval, and Distribution of Biological Materials for Research. 3rd Edition. 2012.

 

p-medicine Consortium. Legal and Ethical Issues Regarding Access to Biobanks. Grant Agreement No.: 270089, Deliverable No.: 5.3.

 

Kurz, X. EU Collaborative Framework for Patient Registries – Pilot Phase. Inspections & Human Medicines Pharmacovigilance Division, Patients’ and Consumers’ Organisations (PCWP) and Healthcare Professionals’ Organisations (HCPWP) joint meeting, September 16, 2014.

 

Swissmedic. GMP compliance by foreign manufacturers of active pharmaceutical ingredients and/or ready-to-use medicinal products. QM-Ident: ZL000_00_014e_MB / V01 / gpa, zim, cas / dts / 02.08.10.

 

European Directorate for the Quality of Medicines & Healthcare (EDQM). New Microbiology Chapters of the European Pharmacopoeia. Council of Europe, October 2–3, 2006.

 

FDA. Compliance Program Guidance Manual: Inspection of Tissue Establishments. CBER, 7341.002A.

 

IARC. Common Minimum Technical Standards and Protocols for Biological Resource Centres Dedicated to Cancer Research. IARC Working Group Report Volume 2. 2007.

 

FDA. Points to Consider in the Manufacture and Testing of Therapeutic Products for Human Use Derived from Transgenic Animals. August 22, 1995. 60 FR 44036.

 

PHS. Guideline on Infectious Disease Issues in Xenotransplantation. August 1996. 61 FR 49920; January 1997. 62 FR 3563.

 

FDA. Guidance on Applications for Products Comprised of Living Autologous Cells Manipulated ex vivo and Intended for Structural Repair or Reconstruction. May 1996. 61 FR 26523.

 

FDA. Proposed Approach to Regulation of Cellular and Tissue-Based Products. February 28, 1997. 62 FR 9721.

 

FDA. Guidance for Human Somatic Cell Therapy and Gene Therapy. Center for Biologics Evaluation and Research, March 1998.

 

ICH. Q4B Annex 8 on Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Sterility Test – General Chapter. EMEA/CHMP/ICH/645592/2008.

 

Health Canada. Guidance Document for Cell, Tissue and Organ Establishments – Safety of Human Cells, Tissues and Organs for Transplantation. 2009.

 

UK Government. The Human Tissue (Quality and Safety for Human Application) Regulations 2007. Statutory Instrument 2007 No. 1523.

 

Human Tissue Authority. HTA Guide to Quality and Safety Assurance for Tissues and Cells for Patient Treatment. November 12, 2010.

 

Standards and Related Guidelines:

 

MSZ EN ISO/IEC 17025:2018 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017)

[MSZ EN ISO/IEC 17025:2018 Vizsgáló- és kalibrálólaboratóriumok felkészültségének általános követelményei (ISO/IEC 17025:2017)]

 

MSZ EN ISO/IEC 17000:2020 Conformity assessment – Vocabulary and general principles

[MSZ EN ISO/IEC 17000:2020 Megfelelőségértékelés szakszótár és általános elvek]

 

ISO/IEC Guide 2:2004 – Standardization and related activities – General vocabulary

 

ISO/IEC Guide 99:2007 International vocabulary of metrology – Basic and general concepts and associated terms (VIM)

 

MSZ EN ISO 15189:2013 Medical laboratories – Requirements for quality and competence

[MSZ EN ISO 15189:2013 Orvosi laboratóriumok. A minőségre és a felkészültségre vonatkozó külön követelmények]

 

ISO 20387:2018 Biotechnology – Biobanking – General requirements for biobanking

 

International Society for Biological and Environmental Repositories (ISBER). ISBER Best Practices: Recommendations for Repositories. 5th Edition. 2023.

 

National Accreditation Authority (NAH). NAR-01 Regulation on the Evaluation Phase of Accreditation, Accreditation Status Renewal, Extension, Extraordinary Supervision, and Surveillance Assessment Procedures (9th edition, June 15, 2020). Hungary.

[NAR-01 Az akkreditálási, akkreditálási státusz megújítási, bővítési, rendkívüli felügyeleti és felügyeleti vizsgálati eljárás értékelési szakaszának szabályzata (9. kiadás, 2020. 06. 15.)]

 

National Accreditation Authority (NAH). NAR-01 Annex 1: Accreditation Program for Testing Laboratories. Hungary.

[NAR-01 1.számú melléklet Vizsgálólaboratóriumok akkreditálási programja]

 

National Accreditation Authority (NAH). NAR-01 Annex 9: Accreditation Program for Medical Testing Laboratories. Hungary.

[NAR-01 9. számú melléklet Orvosi vizsgálólaboratóriumok akkreditálási programja]

 

National Accreditation Authority (NAH). NAR-03 Regulation on the Application of Proficiency Testing and Interlaboratory Comparisons in Accreditation and Surveillance Assessment Procedures. 4th edition, June 1, 2018. Hungary.

[NAR-03 Szabályzat a jártassági vizsgálat és a laboratóriumok közötti összehasonlítás alkalmazásához az akkreditálási és a felügyeleti vizsgálati eljárásokban (4. kiadás, 2018. június 1.)]

 

European co-operation for Accreditation (EA). EA-4/17 M: 2022 - Description of scopes of accreditation for medical laboratories. February 17, 2022.

 

European co-operation for Accreditation (EA). EA-4/18 G: 2021 – Guidance on the level and frequency of proficiency testing participation. November 15, 2021.

 

International Laboratory Accreditation Cooperation (ILAC). ILAC-P9:06/2014 – ILAC Policy for Participation in Proficiency Testing Activities. June 2014.

 

International Laboratory Accreditation Cooperation (ILAC). ILAC-P10:07/2020 – ILAC Policy on Metrological Traceability of Measurement Results. July 2020.

 

International Laboratory Accreditation Cooperation (ILAC). ILAC-G18:04/2010 – Guidelines for the Formulation of Scopes of Accreditation for Laboratories. April 2010.

 

International Laboratory Accreditation Cooperation (ILAC). ILAC G26:11/2018 – Guidance for the Implementation of a Medical Accreditation Scheme. November 2018.

 

University of Szeged Quality Policy

 

University of Szeged Integrated Quality Management System Manual