의약품 허가 후 발생하는 변경사항에 대한 EMEA 관리 지침

Abstract

The objective of this report is to introduce the European Union's variation rules governing medicinal products that are subject to post-approval changes. The EMEA outlines a variety of changes occurring to approved medicinal products. It also recommends a marketing authorisation holder to follow specific post-approval applications in various situations. For instance, the Commission Regulation(EC) No. 1085/2003 explains variation types and suggests post-authorisation procedures with which an applicant should comply. In all cases of minor and major variations the applicant has to investigate and validate whether or not the intended changes would have impact on the safety, efficacy and quality of a drug product. The applicant should then submit to the EMEA a variation application with adequate documentation in support of the notified changes. This procedure is implemented to ensure that changes to the approved medicinal product do not cause my public health concerns. In fact, the post-authorisation guidance categorizes post-approval changes into type IA/IB variations, type II variations, and extension applications. Such classifications determine administrative procedures to be followed in an efficient manner. Based on the type of a variation, the regulatory agency opts to reduce or extend the evaluation time-frame. The thrust of the EU's post-authorisation guidance is introduced in text with appropriate explanation. All these information will be likely to be helpful in updating a Korean regulatory guidance that could better deal with post-approval changes to generic drugs available in the market.