Policies & Legislation

Japan joins international GMP collaboration

Home/Policies & Legislation | Posted 09/12/2016

The European Medicines Agency (EMA) announced on 25 November 2016 that it would be expanding its ongoing collaboration on good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) manufacturers to include Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).

FDA amends citizen petition rules to reduce delays to generics and biosimilars

Home/Policies & Legislation | Posted 25/11/2016

The US Food and Drug Administration (FDA) has amended the requirements for filing citizen petitions and petitions for stay of action to avoid unnecessarily delaying generics or biosimilars applications.

TTIP could further delay access to generics

Home/Policies & Legislation | Posted 11/11/2016

The European Union (EU) and the US risk being locked into higher drug prices during negotiations for the Transatlantic Trade and Investment Partnership (TTIP), according to a joint report released by Health Action International (HAI), the Commons Network and Public Citizen.

Colombia to enforce declaration of public interest for Glivec

Home/Policies & Legislation | Posted 28/10/2016

Colombia’s Ministry of Health and Social Protection (MinSalud) confirmed on 14 September 2016 that it was to enforce a declaration of public interest and cut the prices for blockbuster cancer drug Glivec (imatinib) by 45%.

FDA and industry agree on terms of GDUFA II reauthorization

Home/Policies & Legislation | Posted 07/10/2016

According to minutes from the US Food and Drug Administration (FDA)–Industry Generic Drug User Fee Amendments (GDUFA) Reauthorization Meeting, held on 24 August 2016, FDA and industry have agreed on the terms of a GDUFA II reauthorization package and negotiations have concluded.

EU upholds decision to fine Lundbeck for violating competition law

Home/Policies & Legislation | Posted 30/09/2016

Lundbeck’s appeal of a 2013 decision to fine the company over Euros 90 million for ‘pay-to-delay’ deals on its blockbuster anti-depressant Cipramil (citalopram) has been rejected by European Union (EU) courts.

Australia cuts prices of more than 2,000 brand-name drugs

Home/Policies & Legislation | Posted 09/09/2016

Australia’s Department of Health announced on 4 September 2016 that it would be reducing the cost of more than 2,000 brand-name drugs, some by 50% or more.

FDA lowers fees for generic drug applications

Home/Policies & Legislation | Posted 02/09/2016

An expected increase in generic drug submissions has prompted the US Food and Drug Administration (FDA) to lower its fees for abbreviated new drug applications (ANDA) and prior approval supplements (PAS). The changes will come into effect on 1 October 2016.

Mylan gives up two generic drugs to allow for acquisition of Meda

Home/Policies & Legislation | Posted 26/08/2016

US-based generics manufacturer, Mylan, has divested the rights to two generic drugs. This is in accordance with the Federal Trade Commission‘s (FTC) demands and will allow Mylan to acquire the Swedish pharmaceutical company Meda.

New proposed bipartisan legislation would cut biologicals exclusivity to seven years

Home/Policies & Legislation | Posted 05/08/2016

Back in 2009, President Barack Obama’s government pledged to reduce the cost of biosimilar drugs for consumers and the time taken for those drugs to reach market in an effort to cut healthcare spending, but little has been achieved to date.