Turkish GMP Rules Keeping Critical Meds. From Patients

Turkish GMP Rules Keeping Critical Meds. From Patients

11.09.11 | By

Making sure that patients have access to the medicines they need is - or should be - the top priority of any modern healthcare system. But recent government steps in Turkey will likely prevent patients from getting access to critical medicines. There, the government has discontinued its long-standing process of accepting Good Manufacturing Practice certificates (GMP) issued by foreign (ex-Turkey) regulatory agencies like the U.S. Food and Drug Administration (FDA).
This significant departure from the prior system has raised concerns among a bipartisan group of members of the U.S. House of Representative's Ways & Means Committee. Addressing Turkish Ambassador Tan, the members write:
"We also fear that this new regulation is being implemented in a manner which would block most imported medicines thereby denying patient access to promising new treatments. To the extent the new regulation is intended to protect the health of Turkey's citizens, we believe that the result could be self-defeating."

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