MHRA is seeking input on its draft consolidated regulations and proposals for policy changes as part of its initiative to streamline and harmonize its existing regulatory framework. Comments are due by January 17, 2011.
According to the agency press release, “the current body of UK medicines legislation comprises the Medicines Act 1968 and approximately 200 statutory instruments. It has developed piecemeal since the Medicines Act 1968 came into force some 40 years ago and is fragmented, complex and often difficult to follow.”
MHRA notes in the release that the effort is intended to:
● present the draft consolidated medicines regulations and explain the agency’s approach to producing them
● test that the draft consolidated regulations are a full, accurate and user-friendly legislative text
● ensure that the draft consolidated regulations do not introduce any unintended changes
● seek views on policy changes that we propose to introduce in the consolidated regulations, and
● seek further evidence on the impact of the consolidated regulations and proposed policy changes.