OBJECTIVE： To provide reference for further improving the management of data integrity in drug manufacturing enterprises. METHODS： From perspective of drug data integrity supervision regulations of FDA， World Health Organization（WHO），UK Medicines and Healthcare Products Regulatory Agency （MHRA） and Pharmaceutical Inspection Co-operation Scheme（PIC/S），comparative study was performed according to the relevant laws and regulations of China Food and Drug Administration （CFDA）. RESULTS & CONCLUSIONS： By comparison， data integrity management of pharmaceutical manufacturing enterprises has been paid more attention at home and abroad， and the relevant regulatory regulations on data integrity issued by them have their own characteristics. Firstly， FDA， WHO， MHRA， PIC/S and CFDA emphasize that system access rights should be set， and that anyone entering the system should be authorized so as to ensure data confidentiality and integrity. Secondly， for audit trail function， FDA， MHRA， WHO and CFDA have made clear requirements. Thirdly， both FDA and MHRA emphasize the equivalence between paper records and electronic records， while WHO requires that handwritten raw data must be entered into computer system to make the data traceable； CFDA expresses that both are acceptable. Finally， both domestic and foreign drug supervision institutions attach great importance to the use of risk management tools. However， there are still some deficiencies in China’s laws and regulations concerning the uniqueness of the authorization of personnel entering computer systems and the equivalence between paper data and electronic data.