Regulatory and Procedural Guideline
May 2022
EMA/CVMP/678496/2021-rev
Introduction
“According to Article 37(5) of Regulation (EU) 2019/6 (‘the Regulation’), the European Commission shall adopt implementing acts designating antimicrobials or groups of antimicrobials to be reserved for the treatment of certain infections in humans. On 1 July 2019, the European Commission requested the European Medicines Agency to provide scientific recommendations on these ‘designated antimicrobials’. The EMA’s scientific recommendations, together with the methodology used and the outcome of evaluations of different antimicrobial groups, are provided in this advice. Supplementary information, including supporting monographs prepared for antiviral and antifungal classes/substances and the ATC (vet) codes for substances included in each antimicrobial grouping are presented in the Annex. The EMA has previously provided advice to the Commission in the context of the delegated act referenced under Article 37(4) of the Regulation, to establish the criteria to designate the antimicrobials to be reserved for humans [1]. Therefore, the CVMP considered that the expert group involved with this earlier advice should be requested also to assist in preparing the recommendations relating to the designated antimicrobials. This group consisted of experts from the European Network, EFSA, ECDC, EMA and external experts on human infectious diseases. The CVMP appointed additional experts from the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and from national authorities, who assisted by reviewing working documents prepared for the evaluation by the core expert group. The CVMP is grateful to all the experts for their participation. The mandate and objectives of the expert group were agreed by the group itself and endorsed by the CVMP. The expert group submitted their report to the CVMP on 21 January 2022. The CVMP adopted the scientific advice on 16 February 2022.”
Download Regulatory and Procedural Guideline
Interested in learning more? Contact us today to find out how we can help not only with your EMA/FDA submissions, but all of your global regulatory needs.