Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) have published a best practice guide for marketing authorisation applicants, covering multilingual packaging requirements for mutual recognition (MR) and decentralised procedure (DCP) products. Read more “Are you aware that the CMDh have released a useful best practice guide on multilingual packaging?”

An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data

The Clinical Trial and Imaging Subgroup of the European Medicines Agency (EMA) has released a report on the issues associated with the combination of data from different clinical trials into large datasets. Read more “An overview of the opportunities and challenges posed by bringing clinical trials into the domain of big data”

How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?

Health Canada recently announced the creation of a new Medical Devices Directorate (MDD), to address the challenges and opportunities relating to the ever-changing landscape of the medical device industry. Read more “How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?”

The need for cross-sectoral, global cooperation to fight antimicrobial resistance

The statement emphasises the role of medicines regulators in efficiently bringing safe, effective and high quality antimicrobial products to the market, as well as minimising the regulatory barriers which can prevent access to essential treatments. Read more “The need for cross-sectoral, global cooperation to fight antimicrobial resistance”