Policies & Legislation

FDA issues first warning letter for unpaid generics user fees

Home/Policies & Legislation | Posted 18/10/2013

In what appears to be the first of its kind, FDA has warned CPM Contract Pharma (CPM) for failing to self identify and pay its generic drug user fees.

India’s drug regulator finds no problem at Ranbaxy sites

Home/Policies & Legislation | Posted 11/10/2013

India’s drug regulator has found no major discrepancies at the Mohali manufacturing unit of Ranbaxy Laboratories (Ranbaxy) in contrast to FDA findings.

Health Canada announces plans to tackle drug shortages

Home/Policies & Legislation | Posted 20/09/2013

Health Canada announced on 13 September 2013 plans, which it is hoped will help to address problems the country has been having with shortages of drugs in Canada.

South Africa introduces new patent policy

Home/Policies & Legislation | Posted 13/09/2013

South Africa has become the latest country to examine its patent laws with a view to curbing patent evergreening and increasing production of generics.

Lundbeck fights back against EU pay-for-delay fine

Home/Policies & Legislation | Posted 06/09/2013

Lundbeck announced on 2 September 2013 that it had filed an appeal against the European Commission’s decision to fine the Danish pharmaceutical company, along with four generics makers for pay-for-delay deals.

India to make prescribing of generics compulsory

Home/Policies & Legislation | Posted 30/08/2013

A parliamentary panel is proposing that the Indian Government should bring in legislation that would make it compulsory for doctors to prescribe only low cost generic drugs.

New FDA requirements for generics trials

Home/Policies & Legislation | Posted 16/08/2013

As of January 2014 generics companies may be required to submit data for not just one batch, as is currently the case, but for three batches.

Generics may be allowed to change drug labelling

Home/Policies & Legislation | Posted 02/08/2013

FDA has proposed a new rule which would allow generics makers to change their labelling in the same way as brand-name manufacturers.

Fourth US state rejects law restricting biosimilar substitution

Home/Policies & Legislation | Posted 12/04/2013

Maryland has become the fourth US state to reject legislation that could restrict pharmacists’ ability to substitute cheaper biosimilars for their reference biologicals.

Lundbeck and 4 generics makers fined for pay-for-delay deals

Home/Policies & Legislation | Posted 28/06/2013

The European Commission (EC) announced on 19 June 2013 that it had fined Danish pharmaceutical company Lundbeck and four generics makers for pay-for-delay deals in Europe.