EMA to rejig variations procedures and industry contact staff in April

Canary Wharf, London home to the EMA

Pharmaceutical firms working in Europe may need to update their address books next month after more reorganisation at the EMA.

Earlier today the European Medicines Agency (EMA) announced that, from April 1, it will change how it handles variations to marketing authorisations – both minor and major changes – as well as periodic safety update reports (PSURs) and some other admin procedures.  

The agency explained that: “The main change for applicants to these procedures will be a change in their EMA contact persons. Applicants will be informed directly by product and procedure if and when their contact person will change.”

The EMA announced its intention to restructure last January, explaining that the idea was to streamline its processes with the pharmaceutical industry in mind.

More detailed plans were unveiled in September when the agency explained it would change both how it reviews candidate drugs and how it assesses the manufacturing facilities in which they are produced.

At the time sxecutive director Guido Rasi said the changes will allow the agency to adapt to future challenges and seize opportunities, explaining that: “My aim is to give our scientific committees the best possible support, alongside the expertise from the national agencies, to help them keep delivering high-quality, consistent opinions.

“These changes will enable us to use our resources more efficiently and effectively and ensures that the Agency is better prepared for future legislative and policy challenges."

The restructuring process will continue for the rest of the year according to the EMA, with further modifications to how it reviews drugs being among the planned changes.

The handling of all other evaluation procedures, including initial evaluation applications, will remain unchanged for the time being. Their roll-out is planned for later in the year.”

New roles

Few details of the upcoming changes were provided although the EMA confirmed that it plans to replace its current product team lead model with two new roles: a procedure manager; and an EMA product lead.

The procedure manager will “provide guidance on regulatory procedural matters and serve as the primary contact point for applicants and experts from the national competent authorities.”

The EMA product lead (EPL), in contrast, will monitor oversight of a drug throughout its lifecycle based on expertise in a specific therapeutic area.

Related News

EMA slashes fees for small drug developers

EMA slashes fees for small drug developers

EMA requests more stability data for some manufacturing changes

EMA requests more stability data for some manufacturing changes

Avoiding conflict of interest when an EMA employee takes a new job

EMA issues guidance to ensure job transparency for departing staff

Moving EMA to DG Enterprise will increase risk to patients says NGO

Moving EMA to DG Enterprise will increase risk of adverse events says NGO

EMA PSUR database fit for purpose

EMA PSUR database fit for purpose

EMA and FDA to talk drug safety every month

EMA and FDA to start monthly transatlantic drug safety teleconferences

EMA continuous support for in-process validation

EMA finalizes guidance on process validation for manufacturers

(Picture credit: flickr/SalFalko)

Boehringer Ingelheim biopharma head joins Merck, plus EMA, Shire, EFPIA

US FDA, EMA offer similar explanations for ADC regulations

US FDA, EMA offer similar explanations for ADC regulations

EMA predicts 'no ADC influx' following Roche's Kadcyla launch

EMA predicts 'no ADC influx' following Roche's Kadcyla launch

EMA has made GMP non-compliance data available to public

India and China top 2013's GMP failures, according to EMA data