Regulatory & QA

International Documents
International Documents
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (ICH E2A)
Consolidated Guideline for Good Clinical Practice (ICH E6)
Directive of the Board of the European Community 92/25/EEC regarding the wholesale distribution of drugs for human consumption
Structure and Content of Clinical Study Reports (ICH E3)
WHO Technical Report Series, No. 908, 2003 Guide to good storage practices for pharmaceuticals Annex 9
Good Manufacturing Practices for biological products; Adopted 1991, TRS No 822, Annex 1
WHO Technical Report Series, No. 961, 2003 Guide to good storage practices for pharmaceuticals Annex 9
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects
EUROPEAN COMMISSION
EUROPEAN COMMISSION
Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Re
Commission Directive 2005/28/EC of 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 authorization of the manufacturing or im
Directive 2001/20/EC of the European Parliament and of the Council of 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
Ethical Considerations for Clinical Trials on Medicinal Products Conducted with the Pediatric Population
RUSSIAN FEDERATION
FEDERAL LAWS
Federal Law «On Circulation of Medicines» 61-FZ, 12 April 2010
Federal Law On Public Health Protection in the Russian Federation, No. 323-FZ, 21 November 2011
Tax Code (abstracts), Amount of the State Duty
GOVERNMENT DECREES
Government Decree No. 673 of September 3, 2010 «Approval of Rules for Import and Export of Biological Materials Obtained in Clinical Trials of a medicinal product for medical use into and from the Russian Federation»
Government Decree No. 683 of September 3, 2010 «Approval of Rules for Accreditation of Medical Institutions for the Right to Conduct Clinical Trials of Pharmaceutical Drugs for Medical Application»
Government Decree № 714 «Approval of rules for compulsory insurance of the life and health of patient»
Government Decree No. 771 of September 29, 2010 «On Procedure of Import of medicines for medical use into the Russian Federation»
NATIONAL STANDARDS
GOST R 52249 «Rules for the Production and Quality Control of Pharmaceuticals»
GОST R 52379–2005 «Good Clinical Practice»
ORDERS
Order #2314 from 07 August 2007
Ministry of Health of the RSFSR Order of August 25, 1992 «On the organization of departments of clinical drug trials in healthy volunteers»
Ministry of Health of the Russian Federation Order No. 61n of August 2, 2012 «On approval of administrative regulations of the Ministry of Health of the Russian Federation for the provision of public services for issuing permits for the importation into t
Ministry of Health of the Russian Federation Order No. 266 of June 19, 2003 «On approval of rules of clinical practice in the Russian Federation»
Ministry of Health of the Russian Federation Order No. 703n of August 23, 2010 «On approval of the report form completion, suspension or termination of a clinical trial of the drug for medical use»
Ministry of Health of the Russian Federation Order No. 748n of August 26, 2010 «On approval of the authorization to conduct clinical trials of the drug for medical use»
Ministry of Health of the Russian Federation Order No. 753n of August 26, 2010 «On approval of the organization and conduct of the ethical review of clinical research capabilities of the drug for medical use and form of the conclusion of the Board of Ethi
Ministry of Health of the Russian Federation Order No. 775n of August 31, 2010 «On approval of the review reports on the need for changes in the protocol of the clinical studies of a drug for medical use»
Ministry of Health of the Russian Federation Order No. 951n of November 2, 2010 «On Approval of the register of issued permits (decisions refusing permits) for import to the territory of the Russian Federation and export from the territory of the Russian
Ministry of Health of the Russian Federation Order No. 986n of November 29, 2012 «Approval of the Regulations of the Board of Ethics»
Ministry of Health of the Russian Federation Order No. 1073n of December 3, 2010 «On Approval of the application for a certificate of accreditation of medical organizations for conducting clinical trials of drugs for medical use»
Ministry of Health of the Russian Federation Order No. 1106-Pr/12 of August 29, 2012 «Invalidity of the Federal Service on Surveillance in Healthcare and Social Development Order No 2314-Pr/07 of August 17, 2007 «About the Committee on Ethics»
Ministry of Health of the Russian Federation Order No. 1359n of December 24, 2012 «Invalidity of the Health Ministry of the Russian Federation Order No 774n of August 31, 2010 «The Council on Ethics»
Ministry of Health of the Russian Federation Order No. 1570 of December 27, 2012 «On the composition of the Board of Ethics»
GEORGIA
Georgia
Council of Europe Convention on Human Rights and Biomedicine ratified in 2002
UKRAINE
UKRAINE
The Law of Ukraine "On Medcines" #123/ 96-VR of 04.04.1996 (Articles 7,8,9)
BELARUS
BELARUS
Law of the Republic of Belarus of 20 July 2006 N 161-W,
Decree of the Ministry of Health of the Republic of Belarus #181
Resolution dated May 07, 2009 № 50 "On approval of the Technical Code of Practice "Good Clinical Practice""
Regulation of the Ministry of Health of the Republic of Belarus of March 28, 2008 N 55
Technical Regulations of the Republic of Belarus «Medical Products. Security" (TP2010-006 BY)