Policies & Legislation
Health Canada announces plans to tackle drug shortages
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
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
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
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
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
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
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
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.
India lists API exporters with written confirmation
The Indian drugs regulator has published a list of manufacturers for which it has granted written confirmation that the active pharmaceutical ingredients (APIs) comply with the European Union’s (EU’s) good manufacturing practice (GMP) requirements.
EU lists Japan as having equivalent GMP standards
Japan is the latest country to join Australia and Switzerland on the European Union’s (EU’s) list of countries that comply with its good manufacturing practice (GMP) requirements.
