Policies & Legislation

FDA strengthens and modernizes inspections for sterile injectable drugs

Home/Policies & Legislation | Posted 23/11/2018

On 9 November 2018, the US Food and Drug Administration (FDA) announced that it was taking new steps to modernize its inspections programme with a new way of assessing, recording and reporting the data from surveillance and pre-approval inspections for sterile drug products.

Appeal by Australia’s watchdog against Pfizer ruling dismissed

Home/Policies & Legislation | Posted 16/11/2018

Australia’s High Court has rejected the nation’s competition watchdog’s efforts to revive an antitrust case accusing Pfizer of abusing its market power to maintain control of the Australian generics market for its cholesterol-lowering drug Lipitor (atorvastatin).

New Zealand to fund only biosimilar epoetin alfa

Home/Policies & Legislation | Posted 09/11/2018

New Zealand will stop funding the brand-name epoetin alfa biological Eprex and, in future, will only fund the biosimilar epoetin alfa Binocrit.

EU-US mutual recognition extended to include Portugal

Home/Policies & Legislation | Posted 02/11/2018

The European Medicines Agency (EMA) announced on 20 September 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include one additional EU Member State, Portugal.

Australia encouraging biosimilars and mandating drug shortage reporting

Home/Policies & Legislation | Posted 19/10/2018

In an effort to address both the rising prices of medicines and the risk of drug shortages in Australia the country has introduced drivers to encourage the use of biosimilars and mandatory reporting of drug shortages.

EMA aims to improve the availability of medicines in Europe

Home/Policies & Legislation | Posted 12/10/2018

A European Union (EU) task force, which was set up by European regulators, has published its work programme for 2019/20 and announces a multi-stakeholder workshop.

Biosimilars no longer eligible for parallel processing in Australia

Home/Policies & Legislation | Posted 05/10/2018

Biosimilars will no longer be able to request parallel processing when submitting a biosimilar application for approval in Australia.

Mexico trade deal impacts biologicals exclusivity

Home/Policies & Legislation | Posted 21/09/2018

The US announced a new ‘understanding’ on trade with Mexico on 27 August 2018. The announcement comes as part of efforts to re-negotiate the North American Free Trade Agreement (NAFTA) between the US, Canada and Mexico, which first came into force in January 1994.

AbbVie ruled to pay nearly US$450 million for antitrust violations

Home/Policies & Legislation | Posted 14/09/2018

AbbVie and their partner firm Besins Healthcare have been ordered by the Federal Trade Commission (FTC) to pay US$448 million for preventing generics competition to their testosterone product Androgel. This is the largest amount ever seen in an FTC antitrust case.

EU reinforces collaborations with US and Japan

Home/Policies & Legislation | Posted 31/08/2018

The European Union (EU) is reinforcing its collaborations with both the US and Japan.

Russian court approves first compulsory licence

Home/Policies & Legislation | Posted 20/07/2018

A court in Moscow has made history by granting a compulsory licence to Russian drugmaker Ukrenergo to make a generic version of Celgene Corporation’s (Celgene) flagship blood cancer drug Revlimid (lenalidomide).

CFDA to come under national market supervision administration

Home/Policies & Legislation | Posted 20/04/2018

A sweeping government restructuring plan was approved by China’s National People’s Congress on 17 March 2018. The reorganization will see China’s drug regulator, the China Food and Drug Administration (CFDA), merged into an overarching market supervision administration.

Hatch aims to promote biosimilars and generics and restrict litigation

Home/Policies & Legislation | Posted 13/07/2018

Senator Orrin Hatch filed an amendment to the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act, which was advanced to the Senate by the Judiciary Committee on 14 June 2018.

China to extend drug patents and tackle anticompetitive behaviour

Home/Policies & Legislation | Posted 06/07/2018

According to reports, China is planning to increase patent protection on originator drugs to 25 years, increasing it by five years from the current patent protection period of 20 years. The country is also reportedly going to crack down on corruption and unfair competition in the pharmaceutical sector.