Quality Safety and Standards, Department of Immunization, Vaccines and Biologicals, WHO, Geneva, Switzerland.
Vaccine. 2009 Dec 11;28(2):571-5. doi: 10.1016/j.vaccine.2009.09.117. Epub 2009 Oct 13.
Vaccine developers are required to submit a clinical trial application to the authorities in each country where a clinical trial will be conducted. The application has to be made both to the relevant Ethics Committees and to the National Regulatory Authorities, and only after appropriate clearance by both can a clinical trial commence. This paper describes two specific strategies, joint reviews of vaccine clinical trial applications and joint inspections of clinical trial sites by groups of countries, as part of a WHO initiative to strengthen capacity for the regulatory oversight of clinical trials in Africa. Significantly, the joint reviews and inspections contributed to reinforcing the capacities of the regulatory authorities as well as defining an efficient process to maximize the quality of the reviews and minimize undue delays. Finally we will suggest complementary mechanisms to overcome the potential limitations of joint reviews and inspections.
疫苗开发者需要向将进行临床试验的每个国家的主管部门提交临床试验申请。该申请必须同时提交给相关伦理委员会和国家监管机构，只有在这两者都批准后，临床试验才能开始。本文介绍了两项具体策略，即疫苗临床试验申请的联合审评和国家间小组对临床试验现场的联合检查，这是世卫组织加强非洲临床试验监管能力倡议的一部分。重要的是，联合审评和检查有助于加强监管机构的能力，并确定了一种高效的流程，以最大限度地提高审评质量并减少不必要的延误。最后，我们将提出补充机制，以克服联合审评和检查的潜在局限性。
