China Spells Out License Renewal Requirements for Radioactive Drugs
As production and business licenses for radioactive drugs near expiration, China’s FDA is laying out the requirements for renewals.
License holders will have to submit an application form, license verification documents, a GMP certificate, a five-year self-examination report, the CFDA said.
The self-examination report should provide an overview of production quality management, risk analyses and improvement measures. The CFDA intends to inspect these facilities for compliance and will offer license holders an opportunity to correct any discrepancies.