Please login to the form below

Not currently logged in

MHRA launches pharmacovigilance consultation

Medicines regulator seeks views on draft regulations transposing EU rules into UK law

THe UK's Medicines and Healthcare products Regulatory Agency (MHRA) has begun consulting on plans to give revised European pharmacovigilance rules a statutory footing in the country.

The proposed legislation covers a number of key industry topics, including drug safety and adverse drug event reporting (ADR), and has to be made law within the next seven months.

EU Directive 2010/84/EU on Pharmacovigilance must be transposed to UK law by July 21, 2012 and EU Regulation 1235/2010/EU on Pharmacovigilance has an earlier deadline of July 2, 2012.

The revised legislation's aims include:

• Providing clear roles and responsibilities for key responsible parties and clear obligations for performing their roles

• Rationalising EU decision-making on drug safety issues with a view to preventing unnecessary patient exposure to risks

• Strengthening medicines safety transparency and communication to increase patient and health professional trust in medicine safety

• Strengthening manufacturers' own pharmacovigilance systems

• Ensuring the proactive, and proportionate, collection of high-quality medicines safety data through risk management systems. This would also involve single case and periodic reporting of suspected ADRs

• Involving stakeholders in pharmacovigilance, including through direct patient reporting of suspected ADRs and the inclusion of patients and heath-care professionals in decision-making

• Simplifying the current community pharmacovigilance procedures with consequent efficiency gains for both the pharmaceutical industry and medicines regulators.

The consultation on the transposition of Pharmacovigilance Directive 2010/84/EU is open for comments until February 28, 2012.

The pharmacovigilance measures were adopted in Europe in September 2010 as part of a 'pharmaceutical package' of legislation.

7th December 2011


Featured jobs

Subscribe to our email news alerts


Add my company

Accession was a born from a passion and a vision. A passion to harness the power of market access to...

Latest intelligence

Not another weight-loss ad
Christmas is over and the gyms are packed, it’s a never-ending tale. But why do we do it to ourselves every year?...
China’s clinical trial shake-up
As many of the obstacles to running clinical trials in China fall away, the country is proving to be a better research location...
Alzheimer’s disease – is Europe prepared if a breakthrough treatment becomes available?
Healthcare leaders in the European Union should begin preparing for a breakthrough now...