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Policies & Legislation

New safety requirements for EU medicines

As of 9 February 2019, most prescription medicines and some over-the-counter medicines supplied in the European Union (EU) are legally obligated to have a unique identifier (a two-dimension barcode) and an anti-tampering device on their outer packaging.

Two more countries added to EU-US mutual recognition agreement

The European Medicines Agency (EMA) announced on 11 February 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional EU Member States, Poland and Slovenia.

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.