Stress Test For WHO’s Quality Certificate Scheme In The Americas
A project being run in the Americas will assess the way that the Certificate of a Pharmaceutical Product is used and whether it meets the needs of countries in the region. The move is part of the revision of the World Health Organization’s quality certification scheme.
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New Manufacturing Technologies And Regulatory Convergence Expected To Improve Access In Developing Countries
The key to increasing access to biopharmaceuticals and vaccines in developing countries and to break affordability barriers is through advanced manufacturing platforms and regulatory partnerships such as AVAREF and through WHO's standards setting activities. Yet doubts about the continuing viability of the CPP in promoting access were expressed at recent industry meeting.
The WHO has proposed a revised certification scheme on the quality of pharmaceutical products to address recent changes in the drug regulation environment, including the rapid globalization of the pharmaceutical manufacturing sector.
Following a consultation last year, Medsafe has set new fee levels that take account of both cost-recovery principles and a 4.2% increase in the consumer price index.