Masterarbeit

Referral under Article 31 of Directive 2001/83/EC: An example of vancomycin-containing medicinal products ***

Zeineb Laghmani (2019)

Summary
Language: English
The emergence of multidrug-resistant pathogens is a growing problem worldwide. Vancomycin is one of the antibacterials brought to the market decades ago that contributes to the threat caused by the spread of antimicrobial resistance. It has been used since the 1950s, and to this day, remains an important therapeutic option for the treatment of serious infections. Vancomycin is a tricyclic glycopeptide antibiotic whose active substance "vancomycin hydrochloride" is obtained mainly by fermentation. Its use was questioned in the middle of last century due to ototoxic and nephrotoxic adverse effects related to impurities in its formulation. Considering the importance of ensuring the availability of effective and safe antibiotics for the patients in the EU, a critical review of the benefit-risk function of vancomycin-containing products in the approved indications is considered necessary in the interest of public health, and as a contribution to an efficient reaction to the threat posed by the spread of antimicrobial resistance.
To this end, on 21 March 2016, the Spanish Competent Authority (AEMPS) initiated a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the benefit-risk balance of vancomycin-containing medicinal products and the need of regulatory measures to be taken. As a result of this assessment, the CHMP considered that a number of changes to the product information of vancomycin-containing products were necessary. In particular, the wording of the indications needed to be revised and aligned with the available data, taking into account the existing clinical experience and current guidelines.
From a quality point of view, it was concluded from the consultation of the Quality Working Party (QWP) – on the expression of potency in quantitative and qualitative composition for vancomycin products – that the amount of active substance in the finished product is determined and consistently based on the potency expressed in IU. This results in a change of the weighing of the active substance according to its potency. Consequently, the manufacturing process and batch formulae should be revised, to achieve the declared content.
This thesis intends to give an insight into an Article 31 referral procedure, covering its initiation through its outcome decision up to the description of the amended Common Technical Dossier (CTD) sections in the dossier on the example of vancomycin.
Pages: 49
Annexes: 04, Pages: 10