【讨论】Hong Kong applies for PIC/S Membership.

zhulikou431

Hong Kong has applied to join the PIC/S - Pharmaceutical Inspection Co-operation Scheme.
PIC/S is made up of two distinct parts. 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; however it promotes cooperation and the exchange of information among countries. PIC/S works to promote cooperation among member countries, which include most European countries, the FDA. The EMA a recognized partner is not a member of the PIC/S.
In the last few years South Korea, Japan, Taiwan, Mexico and Turkey have applied for PIC/S membership. Taiwan officially became a member of PIC/S in 2013. Several other Asian countries are reportedly considering joining as well. 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.
There were reports that India may also consider joining the organization as its regulatory standards do not meet global standards and as a result its exports may get affected. However, there is strong lobby of small and medium scale manufacturers who do not want the standards to be upgraded to international level and they may oppose this move.
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.
In a 10 September news release 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 accession process is time-consuming and requires many processes, procedures and documentation to be changed to meet PIC/S GMP standards.

zyq2011

congratulation