EMA, PIC/S to Harmonize Good Manufacturing Practices for Pharmaceuticals

Posted 11 July 2012 | By Alexander Gaffney, RAC

The European Medicines Agency (EMA) on Wednesday, 11 June released additional documents expanding the extent of its cooperation with the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), first announced in December 2010.

PIC/S-composed of PIC and the PIC Scheme, which operate in tandem-works to promote inspection quality and cooperation among member counties, which include most European countries and, as of 2011, the US Food and Drug Administration (FDA). As of 2012, EMA is not a member of the PIC/S, though it is a "recognized partner."

The original agreement between the two organizations called for cooperating to advance the field of Good Manufacturing and Distribution Practice (GDMP) in order to share resources and avoid any duplication of efforts. In particular, the agency said it was interested in the exchange of information, including GDMP guidance documents developed by PIC/S and all legislation related to GDMP.

A Modified Agreement

EMA sought to expand the 2010 agreement in May 2012 with an addendum, stating the two groups should work more on formal, rather than informal, harmonization procedures. "The GMP Guide and related documents should be harmonized between PIC/S and the GMDP Inspectors Working Group (IWG)," the addendum says, "although they need not be identical."

"To reach this goal, there should be an effective and co-operative exchange of information, including drafts and proposals, between both parties on all on-going revisions of existing documents or on the adoption of new documents, and this without delay," explained EMA and PIC/S.

To do this, both organizations will appoint liaison officers to regularly communicate with the other organization about "proposals influencing harmonized documents."

The more formalized approach to the harmonization of guidance documents will include the exchange of proposed and approved concept papers, participation in drafting groups, the exchange of draft documents, the opportunity for public and industry consultation, the preparation of a final draft, approval of final documents and the maintenance of finalized documents.

Addendum to EMA-PIC/S's 2010 Agreement (May 2010)

EMA-PIC/S's 2010 Agreement

EMA's Landing Page for PIC/S Documents

2012 Confidentiality Agreement Signed by PIC/S