The European Union (EU) has just published its proposals to revise its general pharmaceutical legislation. One of the objectives of the revision is to reduce the regulatory burden on the pharmaceutical industry when seeking...more
On 19 September 2022, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint statement confirming that biosimilars authorized in the EU are interchangeable. The EMA defines...more
The European Commission has announced that the Clinical Trials Regulation, already enacted in 2014, will take effect on 31 January 2022....more