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 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.

Please add your comments below or email us.

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Regulatory news

EMA publishes 2015 annual report

Read the report on the EMA website

Human medicines highlights

The latest issue of the European Medicines Agency's newsletter 'Human medicines highlights' is now available.

Launch of the Clarity and Openness in Reporting: E3-based Reference

CORE Reference is now available as an open-access resource

EMA reviewing medicines studied at Semler Research Centre

The European Medicines Agency has started a review of medicines for which studies have been conducted at Semler Research Centre

EMA reviewing medicines studied at Alkem Laboratories

The European Medicines Agency has started a review of medicines for which studies have been conducted at the Alkem Laboratories

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