293 new drugs await regulatory approval in Turkey

A survey of 33 companies from the research-based pharmaceutical industry in Turkey found that the number of new drugs, which are awaiting marketing authorization to reach Turkish patients, has reached 293, including 61 products offering novel therapies to treat cardiovascular diseases, 53 nervous system disorders, 40 cancer, 33 infections, and 24 digestive tract and metabolism conditions.

According to survey results, the average total waiting time has reached 772 days in these products which are pending regulatory approval. The Good Manufacturing Practice Certification policy, introduced last year for certification of foreign manufacturing sites of products which cannot be produced in Turkey, is further prolonging the regulatory approval process, causing additional delays in putting these medicinal products into use.

Regulatory approval timelines lags behind EU standards