Pharmaceutical Red Tape To Be Reduced By MHRA

Regulator Has Committed To A Raft Of Improvements

18.08.2014

The Government has taken steps to begin the process of reducing bureaucracy and red tape within the pharmaceutical industry following a report which highlighted a number of unnecessary, counter-productive or inconsistent demands placed on businesses in this sector by the regulator.

The Medicines and Healthcare Products Regulatory Agency (MHRA) has said it will work with the Department of Business, Innovation and Skills to streamline its processes, increase transparency and provide clearer advice for businesses within the sector.

Earlier this year, Business Minister Michael Fallon said that the UK cannot afford to hold back the pharmaceutical industry with red tape and called for “quick and substantial” reform. A number of recommendations have now been made to the MHRA.

The report said the slow approval process across a range of license application processes were unnecessarily delaying pharmaceutical products from reaching the market, while the number of inspections from overseas visitors was seen to be excessive and too costly.

Another area outlined for change in the report was the conflicting advice and guidance provided by inspectors and the lack of availability of a second opinion on these matters. The report also stated a lack of transparency over the calculation of fees in respect of MHRA activity, for maintaining licences and for inspections.

Businesses within the pharmaceutical industry also praised the work of the MHRA and recognised the need for regulation in this sector.

MHRA Chief Executive Dr Ian Hudson said: “We welcome this review. While we are pleased that we are recognised as a highly respected global regulator that is valued by industry, we are always looking at ways we can improve. We have been, and will continue to work with the Department for Business, Innovation and Skills to reduce the regulatory burden on industry, promote innovation and encourage the development of new healthcare products that benefit people’s health.”

The organisation said it will work with the Home Office Drugs Licensing and Compliance Unit to help businesses get their products to market more quickly by simplifying and improving the core processes for license applications and variations. It has also committed to helping businesses comply with the rules by updating and improving guidance, including the removal of redundant guidance from the regulators’ websites.

Expert Opinion
The findings of the report and the commitment from the MHRA to implement the recommendations are a positive and welcome step, as streamlining, transparency, consistency and continuity are all key to improving the operation of this sector.

“However, it is vital these reforms are considered very carefully, as quick and substantial changes could impact on the safety of the industry and therefore harm the patients using the products manufactured by pharmaceutical companies.

“The strict regulatory measures that have been in place within the sector have made the pharmaceutical industry generally safer for patients than the medical device industry; ensuring only safe medications make it to market.

“We do not want to see the strength of that regulatory regime put at risk when we are calling for regulators to make the medical device industry more patient safety focused.”
Kevin Timms, Solicitor