Throughout the world legislative and regulatory bodies have established standards and criteria which must be met as a protection in use for both patients and users alike. How such legislation is constructed and by whom, varies with each governmental regime. Fortunately, to some extent there is equivalence between the regimes such that meeting the regulatory needs under one generates much of the evidence that is needed by another. To this end, once registration is achieved under one regime, the steps to achieving registration under another are normally incremental rather than revolutionary.
Further steps are being made to harmonise requirements between the major trading blocks. These come under the guise of Mutual Recognition Agreements (MRA). In addition the Global Harmonization Task Force (www.ghtf.org) produces a series of documents covering every aspect of approval. Regulators are taking these on board as the laws are updated or new laws introduced. It is a slow process.