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Quality by design for generics by 2013

Quality by design (QbD) is already being implemented by FDA for new drug applications, but now, in an attempt to prepare generics manufacturers for QbD in 2013, FDA is preparing to publish immediate and modified release QbD examples.

European Commission to investigate patent settlements again

The European Commission (EC) has once again requested information from pharmaceutical companies regarding patent settlement agreements concluded in the European Economic Area (EEA) in 2010 between originator and generic companies.

Row continues over drug shortages

Unhappiness about persistent drug shortages is becoming more acute, both in Europe and the US. Hospitals in The Netherlands are routinely short of around 40 products, whereas in the US 180 medications have now made it onto FDA’s list of scarce products. Hospital pharmacists spend an increasingly large amount of time trying to source scarce items and, despite their best efforts, doctors and patients are increasingly noticing the scarcities.

Industry adjustments as patents expire

Analysts are making some positive predictions as they consider the implications of the continued patent expiry of many blockbuster originator drugs.

New Spanish prescribing laws to promote generics

In an attempt to reduce the healthcare bill the Spanish government has approved new rules to force Spanish doctors to prescribe and pharmacies to dispense generic drugs rather than more expensive brand-named medicines.

Pilot programmes between EMA, FDA and TGA a success

Two pilot programmes of collaboration on inspections between EMA, FDA and the Australian Therapeutic Goods Administration (TGA) have concluded successfully, according to two reports published by the EMA on 2 August 2011. The two programmes were carried out with the intention of increasing international regulatory collaboration in order to increase drug quality and safety.

Market share of generics set to rise as blockbuster patents end

Sales of generic drugs across Europe are expected to grow by 63% in the next three years, mainly because the patents of nine major blockbuster drugs are due to run out [1].

TRIPS and access to essential medicines

A large number of people in the world cannot afford the basic necessities of life, which include access to essential medicines. Policies to encourage generic medicines in poorer countries may go some way to making essential medicines available for all, however, global intellectual property agreements may hinder these efforts.

Europe’s industry concerned about converging prices and patient access

In response to a report on reference pricing in the EU, the European Federation of the Pharmaceutical Industries and Associations (EFPIA) says that while ‘it is rational for a Member State without resources to assess the value [of a medicine] to refer to a similar country that does … it is not appropriate for higher-income countries to mechanistically refer to prices in countries with a much lower purchasing power’.

Concerns over international reference pricing in the EU

An independent report commissioned by the European Parliament’s committee for Environment, Public Health and Food Safety (ENVI) has highlighted some problems with access to medicines due to the widely used practice of international reference pricing within the EU [1].

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