Regulatory Focus™ > News Articles > Korea, Japan Apply for PIC/S Membership

Korea, Japan Apply for PIC/S Membership

Posted 23 April 2012 | By Alexander Gaffney, RAC 

The Korean Food and Drug Administration (KFDA) and Japan's Pharmaceutical and Medical Device Agency (PMDA) have applied for membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), the groups reported.

PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and has been hailed as a "global leader in helping to ensure the quality of drugs" by US Food and Drug Administration Commissioner Margaret Hamburg.

The scheme lacks the legal status and mutual recognition of inspections that other agreements, such as the Pharmaceutical Inspection Convention or the Global Harmonization Task Force (GHTF), convey.

Both KFDA's and PMDA's rapporteurs to the agency will be appointed at the next PIC/S meeting scheduled to be held 7-8 May, the groups said in a statement.


Read more:

PIC/S - Korea applies for PIC/S membership

PIC/S - Japan applies for PIC/S membership

FDA - The Importance of PIC/S in Our Globalized World


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