中藥新藥的注冊(cè)申報(bào)涉及多種情況，其中中藥經(jīng)典名方、中藥注射劑、中西藥復(fù)方制劑等方面均為注冊(cè)申報(bào)或中藥監(jiān)管所關(guān)注的熱點(diǎn)或難點(diǎn)。重點(diǎn)比較了中國香港特別行政區(qū)中成藥注冊(cè)中固有藥類別（古方）與中國內(nèi)地經(jīng)典名方（目前屬于中藥新藥注冊(cè)分類6.1類）注冊(cè)申報(bào)的技術(shù)性資料要求的異同，同時(shí)對(duì)中藥注射劑和中西藥復(fù)方制劑不同的注冊(cè)分類情況進(jìn)行了對(duì)比。

The registration and application of new traditional Chinese medicine (TCM) involves a variety of situations, among which the TCM classical prescription, Chinese medicine injection, Chinese and western medicine compound preparation and other aspects are all the hot spots or difficulties in the registration and application or the supervision of TCM. This paper focuses on the comparison of the technical data requirements of the registration and application of the established medicines category (ancient prescription) in Hong Kong and the classic prescription in mainland of China (currently belonging to the new drug registration category 6.1 of TCM). At the same time, the registration classification of TCM injection and Chinese and western medicine compound preparation was compared.