The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published 253 MHRA regulations last year for public comment as part of the ‘Red Tape Challenge’ (RTC) – a UK Government initiative to streamline and cut bureaucracy across a number of public sectors – and the results have led to the announcement of a number of proposals.
A spokesman for the MHRA told in-Pharmatechnologist.com that the simplification measures “will make it easier for industry to comply with legal requirements through better guidance and lead to greater certainty for industry on when variations will be processed, which should lead to greater efficiency in MHRA and for industry.”
“The overall package will continue to make the UK a competitive place for industry to operate and strengthen the MHRA's claim to be one of the leading regulators in the world.”
The main areas of reform proposed in this announcement are detailed in an MHRA document released yesterday and include:
- An integration of the agency’s website with the Government’s own web platform and a purge of outdated material
- A move towards relying on professional regulation in the safeguarding of the public in relation to healthcare professionals’ use of medicines
- Retaining the simplified application fees package introduced last April during the live phase of RTC
- An implementation of an MHRA notification scheme in order to inform companies when they must submit data
- Amendments to legislation regarding OTC sales – thus opening the doors to sell drugs from trains and planes in a proposed change of law later this year
The simplification process is already well on the way as 208 of the 253 regulations have already been consolidated into the Human Medicines Regulation last year - guidelines which overhauled the nation's 1968 Medicine's Act - and in last December’s MHRA medicine reclassification guide.
Industry Led Changes
This project was “initiated because industry asked for this” and according to the MHRA “the legislation had become fragmented and confusing due to the large number of EU and UK amending instruments to medicines legislation since the Medicines Act 1968.”
The MHRA will continue to collaborate with industry, as well as EU and UK Government implementations, forming the new Medicines Industry Liaison Group which meets for the first time today.