Regulatory pharmacovigilance systems

Broadly, there are two functions to pharmacovigilance from the perspective of a regulator - (1) the protection of public health by measures to prevent serious ADRs and (2) regulation of the industry. Medicines regulatory authorities do not regulate health professionals and prescribers who are able to use medicines outside the terms of the authorisation (and unlicensed medicines) on their own responsibility. 

In terms of protecting public health, regulators are active at every stage of the pharmacovigilance process described in Chapter 4. In particular, they are concerned to ensure that signals are identified 

It should also be noted that regulators have obligations towards industry, in particular the timely transmission of reports which they receive from health professionals to the MA holder. 

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International collaboration in pharmacovigilance has undoubtedly advanced greatly in recent years as communication has improved and regulatory authorities around the world have increasingly engaged in dialogue. In recent years, the EU system has addressed many of the kind of differences alluded to above across the Member States through systems of centralisation and arbitration. 

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