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 Indias 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.
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