February 2, 2021. The COVID-19 Antigen Rapid Test Kit from Xiamen AmonMed Biotechnology has passed PEI comparative evaluation.
The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, in Langen near Frankfurt/Main is a senior federal authority reporting to the Federal Ministry of Health (Bundesministerium für Gesundheit, BMG). It is responsible for the research, assessment, and marketing authorisation of biomedicines for human use and immunological veterinary medicinal products. Its remit also includes the authorisation of clinical trials and pharmacovigilance, i.e. recording and evaluation of potential adverse effects.
The Germany Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) and the Paul-Ehrlich-Institut are the authorities that provide information on SARS-CoV-2 test systems. The information materials complement each other. The legal framework for this, among other things, is the Coronavirus Test Regulation (Coronavirus-Testverordnung, TestV).
This permission marks that our products gain another recognization from global authority. AmonMed is committed to contribute our strength to the global battle against the pandemics.