EMA widens public access to drug information
This article was originally published in SRA
The European Medicines Agency has decided that it will, as a general rule, release all business-related documents once a procedure concerning a medicine has been finalised1. The EMA has been heavily criticised in the past for failing to allow public access to information on certain drugs. It says this latest move is intended to give stakeholders a better understanding of its scientific decision-making process.
You may also be interested in...
The EU General Court has dismissed three cases by pharmaceutical companies that wanted to prevent the European Medicines Agency from disclosing certain data about their marketed medicines on the grounds that it would harm their commercial interests. Firms now have a clearer idea of the standards they will need to meet to claim their information is commercially confidential.
The European Medicines Agency is looking for a clear indication from the EU courts on whether its approach to transparency – as defined in its access to documents policy – is correct.
The European Medicines Agency is developing a strategy to ensure that women have sufficient information to make informed choices about taking medicines during pregnancy and breastfeeding.