By the end of 2007, the UK Medicines and Healthcare products Regulatory Agency (MHRA) was completing “well over” 90% of marketing authorization (MA) applications within its 150-day target, a figure which rose to 100% for applications handled under the European Union (EU) procedure, says the agency’s annual report and accounts for 2007-8.

“In most work areas, we are processing more applications than are coming in, meaning that the work queues are reducing,” the agency reports.

“As we entered 2007, we were conscious that the legacy of the changeover to our new electronic way of working had increased work queues in a number of areas [and] we made an explicit commitment to tackling this in our business plan,” says the agency. As a result, it adds: “the MHRA’s performance improved significantly over the course of last year.”

A particular concern had been the area of clinical trial authorisation for certain novel compounds. Following the TGN 1412 clinical trial incident in 2006 these procedures were changed, but there was concern that, in making these changes, the process of authorising certain clinical trials for particularly novel medicines might be delayed, thereby potentially postponing the development of important new medicines. “In this context, we are pleased that the new procedures are now working well,” says the report.

In his foreword to the report, MHRA chairman Professor Alasdair Breckenridge points out that, while science should continue to lead regulation, the year’s activity also points up the need for regulators to keep pace with the increasingly complex global manufacture, supply and distribution chain for medicines and devices. There has been an increase in the number of counterfeit medicines entering the supply chain and the agency has also had to consider how best to manage the supply and distribution of over-the-counter (OTC) medicines which can be misused to manufacture class A illegal drugs, he says.

The agency reports that it is still gathering evidence following the discovery last year of counterfeit versions of AstraZeneca’s prostate cancer drug Casodex (bicalutamide), Eli Lilly’s schizophrenia and bipolar disorder treatment Zyprexa (olanzapine) and the Sanofi-aventis/Bristol-Myers Squibb antiplatelet drug Plavix (clopidogrel) in the UK supply chain. This case represents the first time that parallel trade is known to have been used as a means of distributing counterfeit medicines, it notes.

During the year, the agency was also successful in prosecuting a gang found to be counterfeiting and distributing products for erectile dysfunction and hair loss. The case, which was the largest of its kind in the UK to date, led to convictions and custodial sentences and “sends out a strong message that the UK will take the toughest action possible against those who break the laws on medicines regulation,” says Sir Alasdair.

However, the agency also notes that, on completion of its four-year investigation into allegations that GlaxoSmithKline had knowingly withheld trial data which showed an increased risk of suicidal behaviour in children, government prosecutors took the view that there was no realistic prospect of a conviction and that the case should not proceed to criminal prosecution. The investigation was the largest over undertaken by the MHRA, and it was the only regulatory agency to conduct a criminal investigation into this issue, it points out.

“We remain concerned that GSK could and should have passed important information to us sooner,” says the report, adding: “we will be strengthening UK legislation and working with EU colleagues to do the same at European level to ensure that the responsibilities of pharmaceutical companies to provide information are clearly and robustly insisted on with the full force of the law.”