Medicines And Medical Devices Agency Applies To PIC/S Scheme
BMI View: While it appears that Turkey is responding to industry concerns over its hostile position on GMP inspections, the reality is that accession to PIC/S is still many years off and furthermore, requires mutual recognition treaties between countries to have meaningful impact on pharmaceutical trade. Turkish regulations will continue to stifle market access and discriminate against foreign drugmakers in the medium term.
The state regulatory body on pharmaceuticals in Turkey, the Medicines and Medical Devices Agency (MMDA) officially submitted its application to the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Tuesday 14th May. In our previous reporting on Turkey, we highlighted the country's listing as the Foreign Priority Country by PhRMA in its annual report to the office of the US Trade Representative (USTR).
PhRMA has raised the issue of Turkey's policy on recognising GMP certificates repeatedly in the US and in Turkey. Currently, the MMDA requires GMP certificates for drug registration procedures. However, Turkey does not mutually recognise international, ISO-certified GMP certificates unless a firm's domicile country has a mutual recognition treaty for Turkish GMP certificates, which neither the EU nor the US does currently. Therefore, multinational drugmakers must wait for Turkish inspectors to approve their manufacturing facilities before they can register drugs with the MMDA. Given the small number of Turkish inspectors and the massive backlog of inspections to be carried out, this is in effect a de facto ban on imports. This policy carries official Turkish state sanction, as part of the AKP's policy of promoting Turkey as a manufacturing hub and reining in its current account imbalances.