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MHRA will take pragmatic approach to pharmacovigilance changes

Won’t expect immediate full compliance to forthcoming EMA legislation

In less than a week the European pharmacovigilance landscape will start to undergo a major series of changes as new legislation comes into effect.

Public drug safety hearings, the replacement of the UK's black triangle scheme with a standard Europe-wide symbol and a greater workload for pharma are just some of the changes that will eventually take place.

But UK pharma will not have to make sweeping changes to its pharmacovigilance approach, come July 1, 2012.

Claire Tilstone is project manager for pharmacovigilance legislation implementation at UK regulator the MHRA and she says it is clear that the necessary changes can't all happen on the date set by the European Medicines Agency (EMA).

“It won't just change overnight and there isn't an expectation of full compliance overnight,” she told the Building on Drug Safety meeting, organised by Doctors.net.uk last month.

Nevertheless, the industry is aware of the scale of change needed and it is thought that many big pharma companies have taken on extra pharmacovigilance staff to cope with the changes.

“The pharmacovigilance changes are the most important piece of medicines legislation since the formation of the EMA in 1995,” Barry Arnold, AstraZeneca's EU qualified person for pharmacovigilance told the meeting.

“Overall they will mean more work and not less at a time when parts of the industry may be looking to reduce the amount of money they invest in this area.”

In particular he pointed to the impact of the greatly increased involvement from patients in pharmacovigilance.

“Marketing authorisation holders will get more case reports, because although the legislation asks patients to report directly to the competent authority, it is inevitable that some of these reports will be sent to pharmaceutical companies instead.”

When it comes to the changes themselves, one of the key themes is to introduce an air of proportionality by considering a 'benefit-risk' assessment for products, the MHRA's Tilstone said.

She also highlighted the EMA's intention to try and get away from “the media image that a drug is either a killer or a major success”.

But the changes could still have a major impact on medicines reporting when, as planned, drug safety hearings are held in public for the first time. 

These will come “in the next few years” Tilstone said, and she suggested they could have a similar format could to those run in the US by the Food and Drug Administration (FDA).

Key pharmacovigilance changes for European pharma:

• A new legal basis allowing the EMA to require post-authorisation safety studies and efficacy studies, either at first authorisation or after authorisation

• A new requirement to have a full pharmacovigilance safety master file (PSMF). This won't have to be formally submitted, just available on request, and because it describes a system not a product, the PSMF can describe one or more products

• The Detailed Description of the Pharmacovigilance System, a predecessor to the master file system, will be phased out from July 2012 to 2015

• The definition of an adverse drug report (ADR) has been widened to include medical error, off-label use, drug abuse and drug mis-use. And patients will now have to be viewed as a valid source of such reports by all EU member states

• There will be a Europe-wide list of products that are subject to additional monitoring, which will include biosimilars and biologics. One consequence of this will be that the MHRA will phase out the black triangle scheme, though the symbol that will be its replacement has yet to be decided

• Risk management plans will be required for all new marketing authorisations from July onwards

• A new EU committee, the Pharmacovigilance Risk Assessment Committee (PRAC), will have new oversight powers and starts meeting next month to support the EMA's scientific advisory committee the CHMP

• There will be open, public hearings about drug safety, with public access to PRAC meetings, agendas and minutes.

26th June 2012

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