The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a composite term used as an acronym for PIC Scheme. This scheme is used to execute tasks of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme.

 The main objective of establishing PIC/S is to harmonize, educate, and update aspects of Good Manufacturing Practices (GMPs) among member countries. PIC/S is a body that has harmonized relations among various Regulatory Authorities and different governments.

PIC/S was established in 1995 as a provision to streamline with 1970s long back established Pharmaceutical Inspection Convention. More flexibility was a significant change in PIC/S. Earlier, European Commission (EC) was permitted to sign agreements with countries outside Europe. But the European Commission is not a member of the Pharmaceutical Inspection Convention of 1970. Therefore, there were some discrepancies between European Law and PIC. The move did not allow the EU countries that were members of PIC to have an agreement with countries seeking to join PIC. It encouraged the emergence of the PIC Scheme. PIC/S is less formal and more flexible, with no legal status. It brings a great understanding between Health Authorities. Thus, PIC/S is a parallel scheme of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperation Scheme. PIC/S has brought understanding among Health Authorities and governments and led to the joint execution of PIC and the PIC scheme activities.

The Role of PIC/S: The PIC scheme aims to provide good quality medicines to the public by harmonizing Good Manufacturing Practices (GMPs) among countries.

Regular awareness, training, sharing of information and experience, and implementing procedures to be followed relating to the manufacture and quality control of medicinal products so that equivalent standards among countries can be implemented.

PIC/S has to thoroughly assess the status of the Regulatory process of a drug Regulatory authority of a country and make necessary changes, if necessary, in the protocols of manufacturing and quality control of drugs.

Australia’s pharmaceutical market is highly regulated and controlled by the TGA. With a team of highly qualified professionals, Freyr can help you with end-to-end Regulatory services in Australia. Consult Freyr today!