medicines-medical devices-medtech-regulatory affairs
medicines-medical devices-medtech-regulatory affairs
The following three forms are now available on the HPRA website. for instructions on completing each form and details of the supporting documents required, See the guidance document ‘Guide to New Applications and Variations to Manufacturer’s Authorisations’ 1) Application Form…
On 26 March 2021, the European Medicines Agency (EMA) has signed a confidentiality agreement with ANVISA, the Brazilian regulatory authority. The agreement is valid for an indefinite period of time and does not require a renewal. It provides the framework under…
The European Commission has published a strategy to support the development and availability of much-needed COVID-19 therapeutics, including for the treatment of ‘long COVID’. The strategy covers the full lifecycle of medicines: from research, development and manufacturing to procurement and…