ABSTRACT
OBJECTIVE：To provide sugge stions for improving the variety of pediatric drugs and ensuring the safety of pediatric drug use in China. METHODS ：The historical evolution of laws and regulations on the marketing approval of pediatric drugs in the United States and the implementation results of relevant policies were summarized. Combined with the current situation of the development of pediatric drugs in China ，some suggestions were put forward to ensure the accessibility and safety of pediatric drug use in China. RESULTS & CONCLUSIONS ：Since 1994，the United States had issued a series of laws and regulations to encourage the development of pediatric drugs. At present ，the marketing approval of pediatric drugs were mainly based on the two laws of Best Pediatric Drug Act（BPCA）and Pediatric Research Equality Act （PREA）. From 1998 to 2019，the amount of supplements of pediatric drug information in drug instructions of the United States showed a fluctuating growth. As of April 2020，854 kinds of drugs had been modified in pediatric instructions ，792 of which had been carried out post marketing pediatric clinical research ，and the problem of incomplete pediatric instructions had also been greatly improved. At present ，China’s policies on pediatric drugs mainly included encouraging R&D innovation ，giving priority to review and approval ，and strengthening R&D technical guidance. Although certain achievements had been made ，there were still some problems ，such as imperfect policies and regulations ，and great difficulties carrying out pediatric drug clinical trials. It is suggested that our country should draw lessons from the American regulations on pediatric drugs ，pediatric research and the catalogue of pediatric drugs ，and establish a system and catalogue of ped iatric drug use suitable for China ’s national conditions ，so as to improve the effectiveness ，safety and accessibilityof pediatric drugs.
ABSTRACT
OBJECTIVE: To provide the basis of improving drug importation registration management system of our country by studying domestic and foreign drug importation management system adequately. METHODS: Checked out and studied the laws associated with import drug of our country and United States with literature research and comparative analysis methods. RESULTS: To reform the drug importation registration management system of our country, related problems should be analyzed. Also the recommendations should be put forward, including the registration of foreign drug establishment, unified registration procedures and adopted DMF system. CONCLUSION: Based on national conditions, we must draw on the advantages of United States system selectively, to improve our system, ensure the quality of import drug lifecycle and protect public health.
ABSTRACT
Background: The antineoplastic drugs are prescribed for the treatment of cancer, which is an important cause of mortality in India; therefore, a drug lag in the availability of antineoplastic drugs is a direct threat to life. The present study was undertaken to assess the drug lag for new antineoplastic agents in India compared with that in the United States (US) or European Union (EU). Methods: The new antineoplastic agents approved in the United States, European Union and India between 1999 and 2011 were identified and information was gathered primarily from the websites of regulatory agencies of the three regions. We assessed absolute and relative drug lag for new antineoplastic agents approved in the three regions. Results: Of the 70 new antineoplastic agents, 64 (91.42%) were approved in the United States, 54 (77.14%) in the European Union and 44 (62.85%) in India. The US was the first to approve 59 (84.28%) out of the 70 new antineoplastic agents, the EU was the first to approve 9 (12.85%) and India was the first to approve 2 (2.85%). The median approval lag for India (26.35 months) was higher as compared to the United States (0 month) and European Union (7.3 months). Conclusions: This study confirms that India’s drug lag in the case of new antineoplastic agents is higher as compared to the US and EU. Further detailed analyses are necessary to find the reasons and impacts of drug lag for antineoplastic agents in India.