While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future.
Paul Hargreaves, chair of PIC/S, explained to attendees at the PDA/FDA Annual Conference in Washington, DC, on Monday that China has expressed interest in joining PIC/S over the years and PIC/S has met with the China Food and Drug Administration (CFDA) but “it’s not a simple process for China because of the way that it’s set up administratively.
“They have different inspectorates in different territories and regions,” he explained, and though it would not be impossible for China to join PIC/S (as Germany has a somewhat similar though significantly smaller setup), the country would have to have agreements across the whole of China, not a “pick and mix” of certain regions, he said, though conversations with China are still ongoing.
“It’s the whole country or not at all,” Hargreaves said, adding that CFDA cannot even decide for itself if it wants to apply as that decision has to come from Chinese politicians. There are also issues with Chinese Taipei and Hong Kong in terms of their membership in PIC/S and other political disagreements over whether they fall under China as a whole.
The situation with India is also “very difficult,” Hargreaves added, noting that a lot of India’s pharmaceutical industry is “very much against joining PIC/S” as it’s too expensive and as the country would have to raise standards significantly to meet PIC/S requirements (although India's commerce ministry has expressed interest in joining). He also explained that some have said if India were to adopt good manufacturing practice (GMP) standards for pharmaceutical manufacturing, the patients in India would not be able to afford the drugs.
Theresa Mullin, director of the office of strategic programs at the US Food and Drug Administration (FDA) and the agency’s ICH lead, said she’s seen similar issues with China with regard to joining ICH, though “India has not participated or attended [ICH] meetings. We haven’t seen any particular interest.”
The lack of Chinese or Indian participation in ICH and PIC/S is particularly concerning as the number of FDA and other regulators’ warnings, Form 483s, import alerts and banned products in both countries continue to increase.
Other ICH and PIC/S Updates
For PIC/S, which continues to harmonize inspection schedules and forge teams of inspectors to run concurrent inspections, now has 49 members, four new applicants (Brazil, Mexico, Iran, Turkey) and threee pre-applicants (Belarus, Chile and Kazakhstan), as well as others showing interest:
And in terms of PIC/S guidance, in addition to the industry-facing guidance on data integrity, Hargreaves said the scheme is also developing guidance for inspectors on data integrity so that more issues can be found upfront.
As far as the ICH restructuring (the council formally became a non-profit under Swiss law last October and is expanding globally), ICH has adopted a new and more formal fee structure. The council is also pushing forward a number of new guidance topics, including some multidisciplinary ones: