Regulatory Focus™ > News Articles > Hong Kong Petitions to Join PIC/S, Joining Long List of Prospective Members

Hong Kong Petitions to Join PIC/S, Joining Long List of Prospective Members

Posted 11 September 2013 | By

Hong Kong's Pharmacy and Poison Board has petitioned to join the Pharmaceutical Inspection Co-operation Scheme, an international forum for the exchange of regulatory information about pharmaceutical products, joining a bevy of other regulators who have asked to join in recent months.


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."

New Members Lining Up

PIC/S has received a bevy of petitions in recent months to join the organization. In May 2013 it received petitions from Mexico's Federal Commission for the Protection from Sanitary Risks (COFEPRIS) and Turkey's Medicines and Medical Devices Agency (TMMDA). Taiwan officially became a member of PIC/S on 2013, and several other Asian countries are reportedly considering joining as well.

Now, in a new development, Hong Kong SAR has applied to become a member of PIC/S through its Pharmacy and Poison Board. In a 10 September posting on the PIC/S website, PIC/S said it will formally begin the membership accession process at the group's next 7-8 October 2013 meeting in Ottawa, Canada.

The "time-consuming" accession process requires the translation of many regulatory documents meant to support a bid, as well as adherence to existence PIC/S good manufacturing practice guidelines.

Other countries now being assessed for PIC/S membership include the UK's Veterinary Medicines Directorate, Brazil's Anvisa, Japan's PMDA, Korea's MFDS, Iran's MoH and the Philippines' PFDA. In addition, Uganda, Belarus and Armenia are all in the pre-application stages.

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