While the pharmaceutical industry will be as affected as any other by the new Regulation on EU packaging and packaging waste, it would also enjoy some limited exemptions under the current proposals.

From the 1st of January 2023 Croatia adopted the euro.

Billev Pharma East will be present at the annual stakeholders meeting as a representative of EUCROF.

EMA has updated its validation checklist for type II non-clinical variations.

Several European regulators provide perspective on the use of mechanistic models in a complex generic drug development.

AI has the potential to greatly impact the regulatory affairs industry by helping with decision-making, detecting deficiencies in documentation, and automating tasks such as document generation and regulatory updates. It can also be used in collaboration with other companies and manufacturers to improve work efficiency and gain insights into drug content and public perception.

A distribution plan should be prepared, including the target groups, the method and timing of distribution.