Policies & Legislation

South Africa to allow parallel imports and compulsory licensing

Home/Policies & Legislation | Posted 15/11/2013

Just two months after releasing a draft policy on intellectual property, South Africa has announced that it will also amend its patent legislation to allow parallel imports and compulsory licensing.

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.

India lists API exporters with written confirmation

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

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

Home/Policies & Legislation | Posted 21/06/2013

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.

US Supreme Court backs FTC in pay-for-delay case

Home/Policies & Legislation | Posted 21/06/2013

On 17 June 2013 the US Supreme Court ruled 5-3 in favour of the Federal Trade Commission (FTC) in the case of FTC versus Actavis with respect to reverse patent settlements or ‘pay-for-delay’, as the FTC terms these deals.

Indian Government moves closer to complying with EU API rules

Home/Policies & Legislation | Posted 14/06/2013

On 23 May 2013, the Indian Government announced that it had issued finalized guidelines for drugmakers to comply with a European Union (EU) directive on standards for import of active pharmaceutical ingredients (APIs) into the EU that takes effect on 2 July 2013.

EU to fine 9 drugmakers over pay-for-delay deals

Home/Policies & Legislation | Posted 07/06/2013

The European Commission (EC) is reportedly ready to fine Danish pharmaceutical company Lundbeck and eight generics makers over alleged pay-for-delay deals in Europe.

Ireland passes bill to encourage generics use

Home/Policies & Legislation | Posted 31/05/2013

On 22 May 2013, the Health (Pricing and Supply of Medical Goods) Bill 2012 was passed by both Houses of the Oireachtas (Irish Parliament).

India introduces new drug pricing control

Home/Policies & Legislation | Posted 31/05/2013

On 15 May 2013, India’s Directorate of Food and Drugs Administration announced the introduction of a new Drug Price Control Order (DPCO), which is expected to lead to price reductions of up to 80% in ‘essential drugs’.

Kazakhstan, Russia, Ukraine to change drug reimbursement schemes

Home/Policies & Legislation | Posted 24/05/2013

Most of the Commonwealth of Independent States (CIS) countries do not have modern drug reimbursement policies. However, recently Kazakhstan, Russia and Ukraine have all taken steps to improve their drug policies and introduce drug reimbursement schemes similar to those employed in other countries.