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Policies & Legislation

Australia plans reform of its generics authorization process

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), announced on 7 February 2019 a public consultation into proposed improvements to its generics authorization process.

UK pharmacists gain powers to address drug shortages

Pharmacists in the UK are gaining news powers to be able to dispense alternatives when there are drug shortages.

45 US states have passed biosimilar substitution laws

Despite the fact that the US Food and Drug Administration (FDA) has yet to approve a biosimilar as interchangeable with its reference biological, many US states have been considering legislation on biosimilars substitution [1].

India tightens regulation on generics manufacturers

The pharmaceutical industry in India ranks third in the world in terms of volume and is the largest provider of generic medicines globally. However, concerns over the quality of generics manufacturing have affected utilization in India. This is demonstrated by poor sales in Jan Aushadhi outlets, which are government-run retail outlets providing generic medicines at an affordable price.

Australia’s TGA will keep same names for biologicals

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has decided to keep the same names for biologicals.

Five more countries added to EU-US mutual recognition agreement

The European Medicines Agency (EMA) announced on 29 November 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include five additional EU Member States, Belgium, Denmark, Estonia, Finland and Latvia.

Patient, health and trade groups say USMCA will keep drug prices high

Patient, healthcare and trade groups have warned that the North American Free Trade Agreement (NAFTA), now known as the US-Mexico-Canada Free Trade Agreement (USMCA) will keep American drug prices high.

FDA strengthens and modernizes inspections for sterile injectable drugs

On 9 November 2018, the US Food and Drug Administration (FDA) announced that it was taking new steps to modernize its inspections programme with a new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products.

Appeal by Australia’s watchdog against Pfizer ruling dismissed

Australia’s High Court has rejected the nation’s competition watchdog’s efforts to revive an antitrust case accusing Pfizer of abusing its market power to maintain control of the Australian generics market for its cholesterol-lowering drug Lipitor (atorvastatin).

New Zealand to fund only biosimilar epoetin alfa

New Zealand will stop funding the brand-name epoetin alfa biological Eprex and, in future, will only fund the biosimilar epoetin alfa Binocrit.