Leng Henry Martin John, Pollock Allyson M, Sanders David
School of Public Health, University of the Western Cape, Cape Town, South Africa.
S Afr Med J. 2016 Mar 17;106(4):43-6. doi: 10.7196/SAMJ.2016.v106i4.10237.
The fast-track registration policy of the South African National Department of Health allows for rapid registration of new medicines of public health importance and of all medicines on the Essential Medicines List, most of which are generics. No limit is placed on the number of generic brands of a medicine that can be submitted for fast-track registration. This, together with resource constraints at the regulator, may delay access to important new medicines, new fixed-dose combinations of critical medicines or affordable versions of biological medicines (biosimilars). One reason for not limiting the number of fast-track generic applications was to promote price competition among generic brands. We found this not to be valid, since market share correlated poorly with price. Generic brands with high market share were, mostly, those that were registered first. We propose that the number of generic brands accepted for fast-tracking be limited to not more than seven per medicine.
南非国家卫生部的快速注册政策允许对具有公共卫生重要性的新药以及基本药物清单上的所有药物进行快速注册，其中大多数为仿制药。对于可提交快速注册的一种药物的仿制药品牌数量没有限制。这一点，再加上监管机构的资源限制，可能会延迟重要新药、关键药物的新固定剂量组合或生物药物（生物类似药）的可负担版本的获取。不限制快速通道仿制药申请数量的一个原因是促进仿制药品牌之间的价格竞争。我们发现这并不成立，因为市场份额与价格之间的相关性很差。市场份额高的仿制药品牌大多是那些最先注册的品牌。我们建议，每种药物接受快速通道注册的仿制药品牌数量应限制在不超过七个。
