On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
European Commission Action Plan on Antimicrobial Resistance
The purpose of the progress report is to inform the European Parliament, the EU Member States and other stakeholders about progress to date in relation to the implementation of the Action Plan. The Action Plan includes a number of specific action points concerning the prevention and control of antimicrobial resistance and for securing the availability of effective antimicrobial agents in the EU. These actions points concern the following key areas:
- Ensuring that antimicrobials are used appropriately in both humans and animals;
- Preventing microbial infections and the spread of such infections;
- Developing new effective antimicrobials or alternatives for treatment;
- Cooperating with international partners to contain the risks of antimicrobial resistance;
- Monitoring and surveillance in human and animal medicinal products;
- Promoting research and innovation;
- Improving communication, education and training.
To promote the appropriate use of antimicrobials for human use, the EU proposes to finance a number of studies to identify the key factors behind the sales and non-prudent use of antibiotics in human medicine obtained without a medical prescription. For example, the progress report indicates that the EU will conduct a study entitled the "ARNA project" to assess the level of enforcement of the requirement in the EU to prescribe antimicrobial agents on a prescription-only basis and to document best practices aimed at strengthening more prudent use of antimicrobial agents.
In addition, the progress report recommends that official therapeutic guidelines be developed at a national or regional level concerning the appropriate use of antibacterial agents. The progress report also proposes that the summary of product characteristics ("SmPC") of all antibacterial agents, including antibacterial agents that are already subject to a marketing authorisation in the EU, include a statement indicating that consideration should be given to official guidance concerning the appropriate use of antibacterial agents.
To address the objective of developing new effective antimicrobials or alternatives for treatment, the progress report discusses a number of collaborative research programmes initiated at EU level which aim to bring new antibiotics to patients. For example, following a joint undertaking between the European Commission and the European Federation of Pharmaceutical Industries and Associations, the New Drugs for Bad Bugs ("ND4BB") programme was launched. The purpose of the ND4BB programme is to permit academic and other public partners, SMEs and the pharmaceutical industry to jointly develop new antibiotics by providing access to each partner's data and collaborate with regards to addressing public health concerns.
To strengthen monitoring and surveillance of antimicrobial consumption in human medicine, the European Centre for Disease Prevention and Control ("ECDC") publishes data concerning the prevalence and indications of antimicrobial use in the EU, Iceland and Norway. This data can be found on the website of ECDC as well as in the detailed annual reports published by the Antimicrobial Resistance Surveillance Network ("EARS-Net").
The progress report also discusses Enterobacteriaceae and indicates that such bacteria represent a new threat to hospitals in the EU. The ECDC is conducting an EU survey concerning these bacteria. The purpose of this survey is to assess new diagnostic and surveillance methods in relation to these bacteria in the EU.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017