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International regulators collaborate on generics

EMA leads three-year pilot project to increase pre-market data sharing

European Union 

The European Union is taking the lead on a three-year project aimed at speeding up the assessment of generic drug applications.  

The International Generic Drug Regulators Pilot (IGDRP) has been set up in a bid to increase the amount of information which international authorities share in the pre-market review of generics.  

This move towards regulatory convergence and co-operation is driven by what the EU says are mounting pressures on health regulatory authorities “due to increasing workloads and risks associated with complex global supply chains”.  

Pressure on healthcare budgets means generics – often available at a fraction of the price of the branded products they imitate – are increasingly important in financial terms to hard-pressed health authorities.  

Europe in particular is being seen by many pharma companies as stony ground when it comes to reimbursement for drugs brands, and they are looking to emerging markets for growth as a result. 

If successful, the IGDRP could lead to permanent moves on work-sharing which the EU believes will “facilitate the timely authorization and availability of safe, effective and quality generic medicines”. 

But it warns that the scheme's success will stand or fall on the support of pharma and other interested parties – although the incentive is that generics should be authorised in different territories in a co-ordinated way at around the same time.   

Sharing assessment reports in real time with participating agencies outside the EU should accelerate the process and make the science of the process more robust, it adds.  

The first phase of the pilot takes in co-operation between the EU, Australia, Canada, Chinese Taipei and Switzerland but other members of the IGDRP - including Brazil, China, Japan, Korea, Mexico, New Zealand, Russia, Singapore and South Africa – can decide to take part later if they wish.  

The project has heavyweight support, with the European Directorate for the Quality of Medicines & Healthcare (EDQM) and the World Health Organisation (WHO) overseeing it as observers.  

The EU says it is also examining the possibilities of work sharing in active substance master file, inspection of sites conducting bioequivalence and bio-analytical studies, and on pharma quality issues.

Article by
Adam Hill

11th August 2014

From: Regulatory



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