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Policies & Legislation

Online consultation on biological drug naming in Canada

Health Canada and the Institute for Safe Medication Practices Canada conducted an online consultation on the naming of biological drugs in 2018.

US government advances five bills to increase generics competition

The US House Energy & Commerce Committee’s Health Subcommittee has advanced five bills related to generic drug competition. The bills have not yet been passed but will each be considered by the full committee.

Anti-price gouging: legislation introduced in Senate while Maryland’s appeal is rejected

Under current law in the US, pharmaceutical companies can raise prices of their products without justification. A 2017 Public Citizen survey revealed that only 14% of the world’s top 29 pharmaceutical companies were willing to limit annual price increases to less than 10%. In February 2019, US senators proposed legislation to reduce prescription drug price gouging, while Maryland’s appeal of a ruling that struck down its anti-price gouging regulation was rejected.

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.