Jefferys D B, Leakey D, Lewis J A, Payne S, Rawlins M D
Medicines Control Agency, London.
Br J Clin Pharmacol. 1998 Feb;45(2):151-6. doi: 10.1046/j.1365-2125.1998.00651.x.
The study was undertaken to assemble a list of all new active medicinal substances authorised in the United Kingdom between 1972 and 1994; to assess whether the pattern of introductions had changed; and to examine withdrawal rates and the reasons for withdrawal.
The identities of those new active substances whose manufacturers had obtained Product Licences between 1972 and 1994 were sought from the Medicines Control Agency's product data-base. For each substance relevant information was retrieved including the year of granting the Product Licence, its therapeutic class, whether currently authorised (and, if not, reason for withdrawal), and its nature (chemical, biological etc.).
The Medicines Control Agency's data-base was cross-checked against two other data-bases for completeness. A total of 583 new active substances (in 579 products) were found to have been authorised over the study period. The annual rates of authorisation varied widely (9 to 40 per year). Whilst there was no evidence for any overall change in the annual rates of authorising new chemical entities, there has been a trend for increasing numbers of new products of biological origin to be authorised in recent years. Fifty-nine of the 583 new active substances have been withdrawn (1 each for quality and efficacy, 22 for safety, and 35 for commercial reasons).
For reasons that are unclear there is marked heterogeneity in the annual rates of authorisation of new active substances. Their 10 year survival is approximately 88% with withdrawals being, predominantly, for commercial or safety reasons. This confirms the provisional nature of assessments about safety at the time when a new active substance is introduced into routine clinical practice, and emphasises the importance of pharmacovigilance.
开展本研究以汇编1972年至1994年间在英国获得批准的所有新型活性药物成分清单；评估引入模式是否发生变化；并研究撤市率及撤市原因。
从药品控制局的产品数据库中查找1972年至1994年间其制造商已获得产品许可的新型活性物质的身份信息。对于每种物质，检索相关信息，包括授予产品许可的年份、治疗类别、是否目前仍获批准（若未获批准，则为撤市原因）及其性质（化学、生物等）。
对药品控制局的数据库与另外两个数据库进行交叉核对以确保完整性。在研究期间共发现583种新型活性物质（存在于579种产品中）已获批准。每年的批准率差异很大（每年9至40种）。虽然没有证据表明批准新型化学实体的年率有任何总体变化，但近年来批准的生物源新产品数量呈增加趋势。583种新型活性物质中有59种已被撤市（1种因质量和疗效问题，22种因安全问题，35种因商业原因）。
由于不明原因，新型活性物质的年批准率存在显著异质性。它们的10年留存率约为88%，撤市主要是出于商业或安全原因。这证实了在新型活性物质引入常规临床实践时对安全性评估的临时性，并强调了药物警戒的重要性。
