Information resources | Voprosy onkologii

Regulatory and Legal International and Russian Documents

Preclinical and clinical studies

World Medical Association (WMA) Declaration of Helsinki, 2013 edition .
European Convention for the Protection of Vertebrate Animals Used for Experiments or Other Scientific Purposes: EST No. 123 of 18 March 1986, Strasbourg
Good Clinical Practice (GCP)
National Standard of the Russian Federation GOST R 52379-2005 Good Clinical Practice (GCP) (in Russian)
GOST 33044-2014. Interstate standard. Principles of Good Laboratory Practice (enacted by Order of Rosstandart dated 20 November 2014 No. 1700-st)
Order of the Ministry of Health of the Russian Federation dated 18 May 2021 No. 464n On Approval of the Rules of Laboratory Research (registered with the Ministry of Justice of Russia on 01 June 2021 No. 63737)

International documents

Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
Regulation (EU) No 536/2014 of the European Parliament and of the Council dated 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC
WMA Declaration of Helsinki
Directive 2001/20/EC of the European Parliament and of the Council dated 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
Commission Directive 2005/28/EC dated 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacture or importation of such products (Text with EEA relevance)
Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Paediatric Population
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)
Structure and Content of Clinical Study Reports (ICH E3)
List of fields contained in the 'EudraCT' clinical trials database to be made public, in accordance with Article 57(2) of Regulation (EC) No 726/2004 and its implementing guideline 2008/c168/02.
The Regulations on Order of Entry into the Customs Territory of the Customs Union of Medicines and Pharmaceutical Products to the Item 2.14 of (Common List of Goods that are subject of import/export prohibitions or restrictions from the part of CU members within the framework of Eurasian Economic Community in trade with third countries

Regulatory documents of the Russian Federation

Federal laws

Decision of the Government of the Russian Federation

Resolution of the Government of the Russian Federation dated 14 March 2022 No. 363 On approval of the rules for the import into and export from the Russian Federation of biomaterials obtained during clinical trials of medicines for human use and invalidating some acts and certain provisions of some acts of the Government of the Russian Federation.
Resolution of the Government of the Russian Federation dated 01 June 2021 No. 853 On approval of new rules for the import of medicines for human use into the Russian Federation and invalidating some acts and certain provisions of some acts of the Government of the Russian Federation.
Resolution of the Government of the Russian Federation dated 13 September 2010 No. 714 (revised on 15 October 2014) On approval of standard rules for compulsory insurance of the life and health of a patient involved in clinical trials of a medicinal product
Government Decree dated 15 September 2008 No. 688 On approval of the lists of codes of medical gods subject to Value Added Tax at the 10% tax rate

Orders

Order of the Federal Service for Surveillance in Healthcare dated 16 September 2022 No. 8700 On approval of the forms of compliance checklists (lists of control questions, answers to which indicate compliance or non-compliance by the controlled entity with mandatory requirements) used by the Federal Service for Surveillance in Healthcare and its territorial bodies in exercising federal state control (surveillance) in the sphere of circulation of medicines
Order of the Ministry of Health of the Russian Federation dated 25 August 2021 No. 880n On approval of the administrative regulations of the Ministry of Health of the Russian Federation for the provision of public services for issuing permits (consent document) for the import into the Russian Federation of a specific batch of registered and (or) unregistered medicinal products intended for conducting clinical trials of medicinal products, a specific batch of unregistered medicinal products for conducting expertise of medicinal products for the purpose of registration and expertise of medicinal products intended for circulation on the common market of medicinal products within the Eurasian Economic Union and (or) the Russian Federation, state registration of medicinal products, inclusion of a pharmaceutical substance in the state register of medicinal products, a specific batch of unregistered medicinal products for providing medical assistance for vital indications of a specific patient or providing medical assistance to a limited contingent of patients with a rare and (or) especially serious disease
Order of the Ministry of Health of the Russian Federation dated 11 January 2021 No 4 On the composition of the Ethics Council
Order of the Ministry of Health of the Russian Federation dated 29 October 2019 No 900n On approval of the administrative regulations of the Ministry of Health of the Russian Federation for the Provision of the State Service for issuing permits (consent document) for the import into and export outside the territory of the Russian Federation of biological materials obtained in the course of a clinical trial of a medicinal product for human use
Order of the Ministry of Health of the Russian Federation dated 07 May 2018 No 202n On approval of the procedure for posting information on the composition of the Ethics Council, its work plans and current activities on the official website of the Ministry of Health of the Russian Federation in the information and telecommunication network Internet and on invalidation of paragraph 22 of the Regulations on the Ethics Council approved by the Order of the Ministry of Health of the Russian Federation of 29 November 2012 No 986n
Order of the Ministry of Health of the Russian Federation dated 19 January 2018 No 20n On approval of the administrative regulations of the Ministry of Health of the Russian Federation for the provision of the state service for granting permission to conduct a clinical trial of a medicinal product for human use
Order of the Ministry of Health of the Russian Federation dated 24 August 2017 No. 558n on approval of the rules for expert review of medicinal products for medical use and the specifics of expert review of certain types of medicinal products for human use (reference medicinal products, generic drugs, biological medicinal products, similar biological medicinal products (also known as biosimilars), homeopathic medicinal products, herbal medicinal products, combination products), forms of approval of clinical trials of medicinal products for human use
Order of the Federal Service for Surveillance in Healthcare No. 1071 of 15 February 2017 On approval of the procedure for pharmacovigilance
Order of the Ministry of Health of the Russian Federation dated 1 April 2016 No. 200n On approval of the rules of Good Clinical Practice (GCP)
Appendix 13 to the Order of the Ministry of Industry and Trade of the Russian Federation dated 14 June 2013 No 916 (revised on 18 December 2015) On approval of Good Manufacturing Practices (GMP) - medicinal products for clinical trials
Order of the Ministry of Health of the Russian Federation dated 29 November 2012 No. 986n On approval of the regulations of the Ethics Council

Order of the Ministry of Health and Social Development of the Russian Federation 951n dated 02 November 2010 On approval of the form of the register of issued permits (decisions on refusal to issue permits) for import into and export outside the territory of the Russian Federation of biological materials (samples of biological fluids, tissues, secretions and products of human activity, physiological and pathological secretions, swabs, scrapings, flushes, microorganisms, biopsy material) obtained during clinical trials of a medicinal product for human use

Order of the Ministry of Health and Social Development of the Russian Federation dated 23 August 2010 No 703n. On approval of the form of report on completion, suspension or termination of a clinical trial of a medicinal product for human use
Order of the Ministry of Health and Social Development of the Russian Federation dated 31 August 2010 No. 775n On approval of the procedure for consideration of a notice of the need to amend the protocol of a clinical trial of a medicinal product for human use
Order of the Ministry of Health and Social Development of the Russian Federation dated 26 August 2010 No. 752n On approval of the procedure for publishing and posting on the official website of the Ministry of Health and Social Development of the Russian Federation on the Internet the list of medical organisations authorised to conduct clinical trials of medicinal products for human use
Order of the Ministry of Health and Social Development of the Russian Federation dated 26 August 2010No. 753n On approval of the procedure for organising and conducting ethical expert review of the possibility of conducting a clinical trial of a medicinal product for human use and the form of the Ethics Council conclusion

National Standard

National Standard of the Russian Federation GOST R 52379-2005 Good Clinical Practice (GCP)«Basic Statistical Reporting for Articles Published in Biomedical Journals: The «Statistical Analyses and Methods in the Published Literature» or The SAMPL Guidelines». Thomas A. Langa and Douglas G. Altman (на английском языке)

«Basic Statistical Reporting for Articles Published in Biomedical Journals: The «Statistical Analyses and Methods in the Published Literature» or The SAMPL Guidelines». Thomas A. Langa and Douglas G. Altman

Other Regulatory Documents

International Committee of Medical Journal Editors (ICMJE) and their Uniform Requirements for Manuscripts Submitted to Biomedical Journals

EQUATOR - Enhancing the Quality and Transparency of Health Research network:

Systematic reviews: PRISMA and extensions
Randomized and Non-Randomized Prospective Controlled Trials: CONSORTand extensions
Observational Studies: STROBEand extensions
Studies of Diagnostic or Screening Methods: STARD
Studies of Diagnostic or Prognostic Models: TRIPOD
Clinical and Economic Studies: CHEERS
Clinical trial protocols for interventions involving artificial intelligence: SPIRIT-AI
Preclinical Studies: ARRIVE
Clinical Case Reports: CARE, extensions
CARE Checklist of information to include when writing a case report https://static1.squarespace.com/static/5db7b349364ff063a6c58ab8/t/5db7bf175f869e5812fd4293/1572323098501/CARE-checklist-English-2013.pdf

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