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Policies & Legislation

Canada clarifies regulatory pathway for subsequent entry low molecular weight heparins

Canada’s federal department responsible for health, Health Canada, is asking drugmakers seeking approval of similar drugs containing low molecular weight heparins (LMWHs) to use the approval pathway for subsequent entry biologics (SEBs), as they are called in Canada.

FDA issues more warnings to Indian firms

The FDA is keeping up its policy of being tough on foreign manufacturers. In its latest action the agency has issued warnings to Indian drugmakers Posh Chemicals and Promed Exports for good manufacturing practice (GMP) violations.

FAST generics act re-introduced to increase generics competition

On 18 June 2015, US lawmakers Steve Stivers and Peter Welch re-introduced the Fair Access for Safe and Timely (FAST) Generics Act to increase consumer access to generics, boost market competition and ultimately save consumers money.

EU stands by call for Ireland to reduce drug prices

The European Commission (EC) is standing by its call for Ireland to reduce spending on medicines in the country, despite objections from originator companies.

WHO issues draft proposal for its biological qualifier

The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. Now the body has issued a draft proposal covering the issue of how to name biologicals, including biosimilars.

Biosimilars substitution bill become law in Texas

Texas is the latest US state to pass a law that will allow the substitution of biosimilars at the pharmacy level. To date, thirteen states have passed legislation requiring prescriber communication and record keeping for biosimilars [1].

Biosimilars substitution bills become law in four US states

The latest states to enact laws that allow the substitution of biosimilars at the pharmacy level include Georgia, North Carolina, Tennessee and Washington.

EMA to hold webinar on publication of clinical trials data

The European Medicines Agency (EMA) has announced that it will hold a webinar on its policy concerning the publication of clinical trials data.

Finnish drug regulator recommends interchangeability of biosimilars

The Finnish Medicines Agency, Fimea, announced on 22 May 2015 that it was recommending the interchangeability of biosimilars for their reference biologicals.

US generics manufacturers renew calls for labelling revisions

The Generic Pharmaceutical Association (GPhA) has stepped up pressure on the US Food and Drug Administration (FDA) to update its proposed generics labelling requirements. According to GPhA, FDA should adopt the joint alternative proposal known as the Expedited Agency Review (EAR) put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA).