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The organisation stated, PV (pharmacovigilance) events are generally a reflection of the properties of the active drug substance and the drug product, irrespective of where it is manufactured. The FDA has an established office in India overseeing the number of qualified manufacturers supplying genericmedicines to the US.
Complex generics: Are global regulators addressing the needs? The development of generic versions of innovator medicines is a global public health need. EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age. Geneva: World Health Organization; 2014. WHO Drug Inf.
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