Table 1 The Outline of Laws and regulations related to Blood Donation and Safety in China
From: The development of a legal framework for blood donation and blood safety in China over 24 years
Type | Act | Legal sources | Implementation Years | Legislature | Main points |
|---|---|---|---|---|---|
Specific Legislations | Regulations on Blood Collection and Supply Institution and Blood Administration | Regulation | 1993 (1998 Expired) | The Ministry of Healtha | Permission of The Blood Centre Blood Donor Registration Promotion of VNBD |
Detailed Rules for the National Verification of External Immunodiagnostic Reagent for Blood Use | Regulation | 1994 | The Ministry of Health | Test of HIV, HBV, HCV, Syphilis | |
Regulations on Administration of Blood Products | Regulation | 1996(2016 Revision) | Instrumentalities of the State Council | Blood Product Administration | |
Blood Donation Law | Law | 1998 | Standing Committee of the National People’s Congress | VNBD System; Blood Only for Clinical Use | |
Measures for the Administration of Blood Centres (for Trial Implementation) | Regulation | 1998 (2006 Expired) | The Ministry of Health | Blood Centre Administration | |
regulations on Clinical Use of Blood in Medical Institutions (for Trial Implementation) | Regulation | 1999 (2012 Expired) | The Ministry of Health | Clinical Blood Use | |
Technical Standards for the Clinical Blood Transfusion | Regulation | 2000 | The Ministry of Health | Corss-Match Test Blood Transfusion Record | |
Measures for the Administration of Blood Centres | Regulation | 2006 (2009, 2016, 2017 Amendment) | The National Health and Family Planning Commissiona | Classification and Management Of Blood Centre Blood Specimen Restoration 2017 Cancellation of Blood Imports and Exports | |
Provisions on Clinical Use of Blood in Medical Institution | Regulation | 2012 | The National Health and Family Planning Commission | Clinical Blood Use Emergency Blood Use | |
Technical Operating Procedures for Blood Centres (2019 Edition) | Regulation | 2019 Edition (2005, 2012, 2015 Edition Expired) | The National Health Commissiona | NAT in clinical use | |
Other Relative Legislations | Regulation on the Handling of Medical Accidents | Regulation | 2002 | Instrumentalities of the State Council | Fault Compensation Liability |
Tort Law | Law | 2010 | Standing Committee of the National People’s Congress | Principle of No-Fault Liability in Blood Transfusion Tort | |
Pharmaceutical Administration Law | Law | 1984 (2001, 2002, 2004, 2016, 2017, 2019 Revision) (2013 Amendment) | Standing Committee of the National People’s Congress | Blood Products Blood Products Cannot Be Commissioned Production and Sell Online | |
Prevention and Treatment Of Infectious Diseases Law | Law | 1989 (2004 Revision) (2013 Amendment) | Standing Committee of the National People’s Congress | Ensure the Quality Of Blood And Blood Products To Prevent Transfusion-Transmitted Diseases | |
Local Legislation | Regulations on Voluntary Blood Donation By Citizens Of Beijing | Regulation | 1992 (1998 Expired) | Beijing’s Standing Committee of the National People’s Congress | Promotion of voluntary blood donors |
Regulations on Shenzhen Special Economic Zone on Citizen’s Gratis of Blood Donation and Blood Management | Regulation | 1995 (2015 Expired) | Shenzhen’s Standing Committee of the National People’s Congress | Reimbursement of VNBD | |
Regulations of Beijing Municipality on Mobilizing and Arranging for Citizens to Donate Blood | Regulation | 1998 (2006 Expired) | Beijing’s Standing Committee of the National People’s Congress | VNBD system | |
Rules of Guangzhou Municipality on Donation of Blood | Rules | 2004 (2015 Amendment) | Guangzhou Municipal People’s Government | Mutual Blood Donation | |
Regulations of Nanning Municipality on Blood Donation | Regulation | 2004 (2012 Revision) | Nanning’s Standing Committee of the National People’s Congress | VNBD system | |
Measures of Beijing Municipality for Administration of Blood Donation | Rules | 2009 | Beijing Municipal People’s Government | VNBD publicity and the service | |
Regulations on Shenzhen Special Economic Zone Blood Donation | Regulation | 2015 (2019 Amendment) | Shenzhen’s Standing Committee of the National People’s Congress | VNBD incentives | |
Measures of Nanning for rewarding blood donation | Rules | 2017 | Standing Committee of Nanning Municipal People’s Government | VNBD incentives and rewarding |