National Authority for Medicines and Health Products (INFARMED): 2016 sets record for innovative drugs approved -
In 2016, the largest number of innovative medicines ever been approved in Portugal, INFARMED said in a statement. During the year, the National Drug Authority approved the financing or reimbursement of 51 medicines, 35 of which were for hospital use, an increase of 38% over 2015.
At the hospital level, there are approvals in the area of oncology, with 13 new drugs in areas such as prostate cancer, myeloma, breast, lung, lymphoma or leukemia. There are still new treatments for rheumatic diseases such as rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis, but also HIV, hepatitis C or Parkinson's disease.
Approvals for hospital use almost tripled in relation to 2015 and exceeded by 52% the results achieved in 2014, which was the year with the most approvals ever after 2016. These approvals will be able to reduce by 40% the number Of Exceptional Use Authorizations (EUS), which hospitals use while evaluation processes are ongoing.
For generic medicines, 493 new submissions were approved, covering six new active substances, including an anti-epileptic, an immunosuppressant or a medicine for osteoporosis. In the hospital, two biosimilars were also approved.
Accelerating the approval of new drugs is considered a priority for the current INFARMED Board of Directors, which has strengthened its structures to meet these goals. This year the Health Technology Assessment Commission (CATS) was set up, which was appointed in June and now counts on one hundred experts, which should be added 20 more briefly.
Source: "Netfarma" website and author on January 13, 2017