WHO plans to evaluate raw materials prompt industry cost worries
This article was originally published in Scrip
World Health Organization (WHO) plans to evaluate active pharmaceutical ingredients (APIs) is worrying industry. WHO is starting a pilot where it will prequalify selected APIs because the globalisation of drug production has made it difficult to verify their quality. However, the pharmaceutical industry is concerned the pilot may increase company costs while a US think tank is worried it may take away from the WHO's core business.
You may also be interested in...
The US Food and Drug Administration recently signalled its desire to work more closely with other drug regulators in assessing the quality of pharmaceutical manufacturing facilities around the world.
It seems as if the US FDA is softening its stance on assessing the quality of pharmaceutical manufacturing facilities around the world in future, with an apparent desire to work more closely with other drug regulators. However, incorporating the regulators from countries such as India, China and Japan into a global inspectorate still looks problematical.
Large pharmaceutical companies and Médecins sans Frontières may not often see eye-to-eye over access to medicines in poor countries. But it seems as if industry and the humanitarian body, a prominent critic, do agree that competition works in improving access to vaccines, even though they don't agree about the mechanisms of price setting.