The US Food and Drug Administration (FDA) has confirmed the good reputation of the Romanian pharmaceutical industry and of the National Agency for Medicine and Medical Devices (ANMDM), by including Romania on the list of EU countries with which the Mutual Recognition Agreement will be implemented, a release issued by the employers in the Industrial Medicine Manufacturers (PRIMER) reads.
PRIMER salutes the Mutual Recognition Agreement, document signed by the European Medicines Agency (EMA) and FDA, aiming at the mutual recognition of inspections conducted to the medicine plants in the EU countries and in the US respectively, capital.ro reports.
“Due to this agreement, EMA and FDA can mutually count on the inspections conducted by the national agencies of the EU countries, on one hand, and by FDA in the US, on the other hand. Thus, there will no longer be needed duplicate inspections, as the capability and the procedures for inspections will be equivalent in the EU and the US, will be recognised a prori, according to the document. Actually, the drugs manufactured in Romania can be exported immediately after being registered in the US, without an FDA inspection, the competent authority in the US,” Dragos Damian, PRIMER Executive Director, said.
By including Romanian in the Mutual Recognition Agreement, the pharmaceutical production facilities in Romania are qualified for recognition by the FDA in terms of quality processes, of the local issued certificates of good practice.
The drug manufacturing units in Romania are in Bucharest, Targu Mures, Iasi, Cluj-Napoca, Constanta, Sibiu and Baia Mare and have carried out investments amounting to EUR 500 million in the past ten years in order to remain competitive, the release also reads.