The Bulgarian Drug Agency officially joined the PIC/S
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02 Jul The Bulgarian Drug Agency officially joined the PIC/S

Posted at 09:41h in GMP/GDP, Regulatory Affairs by

The Bulgarian Drug Agency (BDA) officially joined the PIC/S – Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme as its 55th Participating Authority, effective from July 1, 2023.

PIC/S is a non-binding co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. It is open to any Authority having a comparable GMP inspection system. PIC/S comprises more than 50 Participating Authorities coming from all over the world (Europe, Africa, America, Asia, and Australia).

PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to inspectors. It also aims at facilitating co-operation and networking between competent authorities, regional and international organizations, thus increasing mutual confidence.

The country’s membership in PIC/S will bring benefits primarily to the Bulgarian pharmaceutical industry, but also to the international recognition of BDA, not only within the EU, but also on a global scale.