Turkish cancer patients unable to access new drugs on time as regulatory process lengthens, warns trade group

The human and financial cost from cancer is rising by the day in Turkey where 155,000 people get the disease, 60,000 of them fatally, every year. Difficulties mark bringing medicines to Turkish patients on time to treat cancer, an area of medicine where new discoveries are made and novel medicines developed incessantly, reports the local research-based pharma industry association the AiFD.

The regulatory approval procedure, which should be 210 days, is taking 655 days or more in the case of cancer drugs, which restricts access of patients to new medicines who acutely await them. The difficulties have been further aggravated by the introduction of a new policy this year of requiring Good Manufacturing Practice (GMP) certification. According to this new policy, applications for marketing authorization submitted without a GMP certificate recognized or issued by the Ministry of Health after inspection are dismissed without even a pre-evaluation of the product. According to the AiFD, the 287 new products whose importation is imperilled by this new policy include 22 cancer drugs.

Estimated direct cost to Turkey is 1.8 billion euros annually