Regulatory Focus™ > News Articles > Taiwan's FDA Says it is Aiming for 2013 Induction into PIC/S

Taiwan's FDA Says it is Aiming for 2013 Induction into PIC/S

Posted 05 October 2012 | By Alexander Gaffney, RAC 

Taiwan is preparing to join the Pharmaceutical Inspection Convention and Cooperation Scheme (PIC/S) in 2013, vaulting ahead of several other Asian countries preparing to do the same, reports Taiwan Today.

PIC/S is an informal arrangement between consenting health regulatory authorities to exchange information, and chiefly works to promote the quality of pharmaceutical products.

The organization is made up of two distinct parts which are different in 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.

The director general of Taiwan's Food and Drug Administration, Kang Jaw-jou, said in a statement to Taiwan Today that participation in PIC/S, "Allows Taiwan to access the latest drug data and better safeguard the health of its people."

"This information will also sharpen local manufacturers' global competitiveness, attracting international heavyweights to contract out production or even set up shop on the island," added Kang.

Taiwan started the process to obtain PIC/S membership in June 2010, which required extensive inspections and revisions to its legislative framework to complete. Kang said he expects the process to wrap up within the next year, which should allow Taiwan's industry to access foreign markets with greater ease.

Other Asian nations have recently made inroads toward involvement in PIC/S. Both Korea and Japan applied for membership earlier in 2012, but PIC/S has not specified either the extent of their involvement or any timeframes for the acceptance of their respective applications.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.