The year 2021 is likely to be remembered as the year of reduced marketing authorizations for drugs. This was greatly influenced by the changes in the market and the new regulations that were introduced last year. In particular, the pricing penalty imposed on indirect bioequivalence tested drugs and the restrictions set on consigned bioequivalence tests had greatly contracted the development of consigned generic drugs, significantly decreasing the number of approved items compared to the previous year.

◆ In 2021 = a total of 2,057 items were approved, recording the lowest-ever number of approvals during the past 4 years. 2,112 items were approved in 2018, 4,8