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The harm(s) a drug may cause may not be known at the time it gains market authorisation. Drug regulatory agencies weigh the benefits that the drug presents against the potential harms it could pose and allow it to be marketed if it is believed that the drug has a favourable risk-benefit ratio. Regulatory agencies then evaluate the drug’s risk profile as it is used on a large scale and institute remedial measures if found necessary. Data is needed in establishing that an Adverse Event (AE) accompanying drug use is, in fact, an Adverse Drug Reaction (ADR), and in carrying out the functions outlined above. This paper explores some of the issues involved, the importance of data in the work of regulatory agencies and draws attention to the need for all to facilitate the work of regulatory agencies.