The Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S), an international forum for the exchange of regulatory information about pharmaceutical products, may soon see itself with two more members, it announced on 14 May 2013.
The organization is made up of two distinct parts which are different with regard to their authority. The first part, the Pharmaceutical Inspection Convention, is a legally binding set of standards agreed upon and mutually recognized by signatory countries. The second part, the Pharmaceutical Inspection Co-operation Scheme (PICS), is not legally binding, but still promotes cooperation and the exchange of information among countries.
PIC/S works to promote inspection quality and cooperation among member countries, which include most European countries and, as of 2011, the US Food and Drug Administration (FDA). As of 2012, the European Medicines Agency (EMA) is not a member of the PIC/S, though it is a "recognized partner."
As with any international regulatory organization, PIC/S is only as strong as the number of countries that recognize it and its efforts. And if recent developments are any indication, it is getting stronger. In April, South Korea's Ministry of Food and Drug Safety (then known as the Korea Food and Drug Administration) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) applied for PIC/S membership. In July 2012, EMA said it wanted to forge stronger ties with PIC/S through the use of appointed liaisons to communicate and influence harmonization efforts. And in October 2012, Taiwan's Food and Drug Administration announced it would attempt to join PIC/S in 2013 in order to "access the latest drug data and better safeguard the health of its people."
Two New Members?
And now PIC/S could soon see two more members as well. The organization announced on its website on 14 May 2013 that both Mexico's Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and Turkey's Medicines and Medical Devices Agency (TMMDA) have applied for PIC/S membership.
Mexico is reportedly still in the pre-accession stages of joining the organization, and will have PIC/S rapporteurs appointed to it at the next meeting of the organization (28-29 May 2013 in Geneva) meant to help guide it through the process of preparing a formal application to join. Turkey, meanwhile, has formally applied for membership.