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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

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