Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Open this folder and view contentsGood certification practice
Open this folder and view contentsCounterfeit drugs: challenges and solutions
Open this folder and view contentsCurrent issues in regulation and quality
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Open this folder and view contentsTransparency in monitoring the safety of medicines
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Close this folderAntimicrobial resistance: battling the bugs
View the documentCountry experience in implementing antimicrobial resistance strategies
View the documentVeterinary, aquaculture and agricultural use’ of antimicrobials contributing to resistance
View the documentThe role of regulators in the containment of resistance
View the documentRecommendations
Open this folder and view contentsSafety issues of plasma-derived medicinal products
Open this folder and view contentsHerbal medicines
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

As part of WHO’s global strategy for the containment of resistance to antimicrobial drugs, and in collaboration with Member States, WHO is invited to:

1. Bring together national authorities for human and veterinary drug regulation to exchange information and to consider joint action.

2. Provide guidance on the clinical development of antimicrobial drugs, in particular to optimize efficacy while minimizing the risk of resistance.

3. Establish a common format for product information and patient information leaflets, specifically addressing antimicrobial resistance issues such as specifications for medicines, susceptibility of common pathogens and measures to prevent resistance. Special attention should be given to improving the communicative potential of the information provided. This information should be regularly updated in the light of prevailing resistance patterns.

4. Continue efforts, as set out in WHO resolution WHA 51.17, to make antimicrobial drugs available on a prescription-only basis.

5. Stimulate drug regulatory authorities to share all relevant information on clinical trials involving antimicrobial drugs, with public health authorities.

 

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Last updated: April 24, 2012