Regulatory Reliance Key To Cancer Drug Access in Lower-Income Countries
Regulatory reliance will be vital in improving access to oncology medicines in low- and lower-middle income countries, delegates at a recent regulatory conference were told.
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Initiatives from regulators around the world seek to promote regulatory reliance at global level.
As medicines agencies increasingly turn to worksharing and other mechanisms to reduce duplication of effort, the Access Consortium has thrown its weight behind the use of reliance processes for national good manufacturing practice inspection outcomes.
IMC, the R&D-based pharmaceutical industry association in Canada, says the guideline will “exacerbate an already unpredictable regulatory environment.”