Consultations

On this page we list current agency and government consultations that are relevant to regulatory affairs and regulatory professionals. 

TOPRA aims to keep members informed of important consultations as they are issued. We realise that many members are able to make comments on public consultations through their employing organisations or the trade associations. However, we also recognise that these avenues are not available to everyone and also that individual regulatory practitioners might have additional observations to make from a personal or professional perspective.

As an organisation, TOPRA does not give an opinion on consultations, but as the professional association we provide this means for individual regulatory professionals to share their observations and get their voices heard. If the comments received indicate a common concern then TOPRA will ensure that this is drawn to the attention of the organisation issuing the consultation, without identifying the individual respondents.

 

Human medicines

Body Closing date Summary
EMA  31 October Call for scientific data for the periodic review of themonograph on Serenoa repens (Bartram) Small (Sabalserrulata (Michaux) Nichols) 
EMA  31 December  Guideline on registry-based studies 

Veterinary medicines

Body Closing date Summary
EMA 31 October 2020 Concept paper for the development of a reflection paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals. 

Medical devices

Body Closing date Summary
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