The evaluation committee for the Pharmaceutical Inspection Cooperation Scheme (PIC/S) is expected to recommend FDA’s acceptance into the 37-member organization at the next PIC/S meeting in Kuala Lumpur, Malaysia in November. Membership accession could follow by year’s end.
After a somewhat thorny five-year evaluation period made more difficult by the complexity of FDA’s organizational structure, a positive revisit from the PIC/S evaluation team in August has cleared the way for the upcoming recommendation.
At the annual PDA/FDA conference in mid-September in Washington, D.C., FDA Office of Regulatory Affairs (ORA) Strategic Initiatives Executive Director Brenda Holman provided an in-depth review of FDA’s lengthy application process and the results of the recent on-site audit. Holman has been actively involved in helping guide the agency through the end-game of the process.
Along with shedding light on the FDA application and assessment process per se, Holman provided insight in her presentation into PIC/S’: ● history ● role and function ● accession procedure, and ● current guidance development, training, seminar and quality system activities.
[Holman’s insights and links to referenced PIC/S documents discussed are provided for subscribers here. For subscription information click here.]
