Mexico, Turkey and Iran will start participating in the international Pharmaceutical Inspection Cooperation Scheme as of January 2018. Meanwhile, Russia has become the latest country to apply to join the scheme.
Drug regulators from Mexico, Turkey and Iran are to become the newest members of the Pharmaceutical Inspection Cooperation Scheme (PIC/S), which currently involves 49 authorities from 46 countries working to harmonize manufacturing inspection procedures worldwide.
Mexico’s agency COFEPRIS, the Turkish Medicines and Medical Devices Agency and Iran’s Food and Drug Administration will start to participate...
The FDA wants to ensure participants in clinical trials involving genetic engineering done in China understand what the agency sees as privacy and security risks. The agency also wants cell therapy processing done outside of “hostile” countries.
Davis, a former FDA team leader in the Division of Psychiatry Products, rejoins the agency from the Usona Institute, which develops psychedelics. His background aligns with Commissioner Martin Makary’s goal of seeing new treatments approved for post-traumatic stress disorder.
As the EU tests the feasibility of a radical “all-in-one” procedure for combined drug and IVD studies, sponsors are being urged to approach this novel framework with flexibility and openness.
