Bulgaria is included in the GMP Mutual Recognition Agreement between EU and USA

Bulgaria is included in the GMP Mutual Recognition Agreement between EU and USA

In May 2019 the Bulgarian Drug Agency (BDA) announced that after auditing the US FDA confirmed the BDA capacity and ability to perform GMP inspections equivalent to the US standards. On the basis of the sector agreement between the European Commission and the USA, there will be mutual recognition of GMP inspections of drug manufacturing sites. Currently the sector agreement covers the medicinal products for human use except vaccines, plasma-derived medicinal products and medicinal products intended for clinical trials.