Fulfilling Pharmacovigilance Obligations in Innovator Pharmaceutical and Generic Manufacturer Partnerships

The challenging market conditions (which include governmental demands and the weight of supporting global distribution channels) are driving the global pharmaceutical industry to explore new growth opportunities in emerging markets, to focus on operational efficiency and to move towards a mixed portfolio of innovative and generic products. Such changes are responsible for the substantial increase in the number of licensing and supply partnerships between generic manufacturers based in an emerging market and large to mid-sized global pharmaceutical companies – specifically for the marketing of pharmaceutical products.

Special considerations in terms of regulatory obligations are required in the setting up of global pharmacovigilance operations in the manufacturing and marketing partnerships discussed here. The characteristics of these partnerships are often unique, and although there are some similar considerations taken when addressing pharmacovigilance, there will be unique challenges and complexities which require careful planning.

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