RESUMEN
OBJECTIVE:To investigate the risk,advantages and disadvantages and countermeasures of new drugs,generic drugs and imported drugs in different transfer opportunities,and to provide basis for improvement of development strategy for phar-maceutical enterprises. METHODS:The analysis was done in accordance with relevant regulations on transferable projects in the process of applying for registrations of new drugs,generic drugs and imported drugs. The transfer period and risk were explored and countermeasures were put forward. RESULTS & CONCLUSIONS:Transferable projects included intellectual property rights (patents,patent application,technical secrets,application information,non-disclosed data,etc.)and ownership rights(clinical tri-al approvals,new drug certificates,drug approval number,pharmaceutical product registration certificates,imported product regis-tration certificates,etc.)in the process of applying for registrations. There are 4 opportunities for drug technology transfer,opportu-nity 1 is before applying clinical trial approvals after the completion of non-clinical research such as pharmacology,toxicology;op-portunity 2 is ahead of clinical trial after the acquirement of clinical trial approvals;opportunity 3 is new drug technology transfer;opportunity 4 is production technology transfer. The new drugs have 4 transfer opportunities,generic drugs and imported drugs can transfer in opportunity 1,2,4. Different transfer opportunities present different risks and profits. The risk gradually decreases with the further promotion of drug registration process,while the innovation decreases at the same time. Pharmaceutical enterprises should combine with the policy,market and their own features to select a suitable transfer period.
RESUMEN
OBJECTIVE: To learn from several developed countries and regions about their experience of orphan drug registration management and to explore appropriate orphan drug registration policy for China. METHODS: The orphan drug registration policies of America, Japan, EU, Australia and Taiwan were analyze and compared, and the history and current situation of the orphan drug registration in China were summarized. RESULTS: It has been a common trend in the world to use "designation of drugs + market approval" pattern for orphan drug registration, which has promoted the development of orphan drugs and increased the accessibility of orphan drugs in the above-mentioned countries and regions. CONCLUSION: Related government departments in China should learn the advanced experience and establish our orphan drug system as soon as possible, at the same time, we should keep improving the orphan drug registration policy in China.