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Pharmacovigilance professionals from the company are involved early in the product development process. For already-on-the-market products, a Safety Specification and Pharmacovigilance Plan can be produced (e.g., new indication or major new safety concern). The Plan could be used as a starting point for discussions with regulators in the various ICH regions and beyond on pharmacovigilance initiatives.New information will be generated after a product is marketed, which may have an impact on the product's benefits or hazards; examination of this information should be a continuous process, in conjunction with regulatory authorities. To ensure that all products are safe to use, detailed review of information obtained by pharmacovigilance operations is required. The benefit-risk balance can be improved by minimising patient hazards through good pharmacovigilance, which allows for prompt information input to pharmaceutical users. Before a product is approved or a licence is granted, industry and regulators have recognised the need for better and earlier planning of pharmacovigilance efforts. This ICH recommendation was created to promote harmonisation and uniformity, as well as to avoid duplication of effort, and could be of benefit to public health programs throughout the worldas they consider new drugs in their countries.These reviews highlight relationship between the pharmaceutical Industry and pharmacovigilance.


Pharmacovigilance, clinical studies, Premarketing trial, good pharmacovigilance practice, post marketing surveillance, Spontaneous reporting, cohort studies

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