OBJECTIVE  To investigate the implementation of the clinical trial institution filing system, analyze the development status and existing problems of clinical trial institutions in Shanghai, and propose countermeasures and suggestions.

METHODS By searching the National Medical Products Administration websites, filing platform, and drug clinical trial registration and information disclosure platform, and conducting a questionnaire survey among clinical trial institutions in Shanghai, this study analyzed the development status and existing problems of drug clinical trial institutions in Shanghai.

RESULTS A total of 13 questionnaires were collected, with 13 valid questionnaires. After the implementation of the filing system, 70 institutions had been registered on the filing platform in Shanghai, among which 36 were tertiary Class A hospitals, accounting for the largest proportion. In terms of drug types, biological products showed the most significant increase, while traditional Chinese medicines, natural medicines, and chemical drugs experienced only modest growth. Apart from internal medicine and surgery, oncology had the highest number of registered institutions, with traditional Chinese medicine also ranking high. Since the implementation of the filing system, the number of filings for new institutions, new specialties and address changes had increased substantially.

CONCLUSION After the implementation of the filing system, drug clinical trial institutions in Shanghai have problems such as uneven distribution of medical resources, shortage of resources in phase I clinical trial laboratories, and incomplete implementation of institutional supervision and inspection. It is suggested that improvements can be made by increasing the number of drug clinical trial institutions, raising the awareness of improving the visibility of clinical trial institutions, strengthening the capacity and expertise of drug clinical trial personnel, promoting the construction of phase I clinical trial laboratories, and strengthening the supervision and quality control of clinical trial institutions.