Policies & Legislation

EU API law causing concern among API producers

Home/Policies & Legislation | Posted 22/03/2013

Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013, all imported APIs were required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP and as of 2 July 2013 this compliance must be confirmed in writing by the competent authority of the exporting country. Alternatively, the country may request listing (on the ‘white list’) if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.

Tighter EU rules on pharmacovigilance for biologicals

Home/Policies & Legislation | Posted 06/04/2012

Last updated: 11 March 2013

The new EU pharmacovigilance legislation which comes into force in July 2012 will include a tightening of requirements relating to product information and identification, as well as the regulations surrounding biosimilars and automatic substitution by pharmacists.

MEPs adopt directive to give quicker access to generics

Home/Policies & Legislation | Posted 15/02/2013

Members of the European Parliament (MEPs) have adopted the text of the Transparency Directive 2012/0035(COD) by a large majority in a plenary session of the parliament on 6 February 2013.

FDA gives details of generic drug user fees

Home/Policies & Legislation | Posted 01/02/2013

FDA has detailed the amounts that generics and active pharmaceutical ingredient manufacturers will have to pay under the Generic Drug User Fee Amendments of 2012 (GDUFA).

India issues more compulsory licences

Home/Policies & Legislation | Posted 24/01/2013

The Indian Government is once again planning to issue compulsory licences for three patented cancer drugs, allowing local drugmakers to launch generic versions of the drugs before the patents expire on the originator drugs.

India’s patent office at odds with Big Pharma

Home/Policies & Legislation | Posted 14/12/2012

India and its patent laws are increasingly being challenged by Big Pharma. In its most recent decision, the Indian Patent Office has rejected AstraZeneca’s patent appeal on Iressa (gefitinib). Somewhat controversially the office has been asked by the Supreme Court, however, to reconsider Pfizer’s patent on Sutent (sunitinib). Meanwhile, it is still to issue a final verdict in Novartis’ legal challenge against India’s patent laws.

Generic pre-emption raises its ugly head again

Home/Policies & Legislation | Posted 07/12/2012

The US Supreme Court is to review a case, which could determine whether generics companies can be held responsible for design flaws in the drugs they copy.

FDA to tighten control over generics

Home/Policies & Legislation | Posted 23/11/2012

A single incident of an extended-release formulation that released its drug too quickly has caused FDA to change its policy. An FDA official said in October 2012 that the agency would be looking more closely at the techniques generics drugmakers use to make extended-release drugs.

Major shake-up of API import rules in Europe

Home/Policies & Legislation | Posted 23/11/2012

EU is seeking to impose good manufacturing practice (GMP) standards throughout the world in an attempt to stop the import of counterfeit or substandard active pharmaceutical ingredients (APIs) for human-use medicines. The new rules will come into force next year.

Pharmaceutical trade barriers are falling

Home/Policies & Legislation | Posted 16/11/2012

The European Parliament has voted in favour of a trade pact between Israel and the European Union (EU) that will allow easier access to medicines from both markets. The EU is also seeking to reduce barriers to other Mediterranean neighbours and Canada.

India patent laws under close scrutiny

Home/Policies & Legislation | Posted 09/11/2012

The international pharmaceuticals community is watching closely as Pfizer appeals against a decision to revoke its patent on Sutent (sunitinib).

Generic drug user fees come into effect

Home/Policies & Legislation | Posted 19/10/2012

Legislation allowing FDA to collect several user fees under the Generic Drug User Fee Amendments of 2012 (GDUFA) was approved by the US Congress’s House Energy and Commerce Committee on 21 September 2012. FDA User Fee Corrections Act of 2012 amends the FDA Act to address certain issues raised by language included in the GDUFA.

MSF launches online ‘Patent Opposition Database’

Home/Policies & Legislation | Posted 26/10/2012

The international medical humanitarian organisation Doctors Without Borders/Médecins Sans Frontières (MSF) has launched an online resource to help civil society and patient groups in developing countries challenge unwarranted drug patents.

India plans further cuts to drug prices

Home/Policies & Legislation | Posted 12/10/2012

The Indian government has announced plans to further extend price cuts on both generic and brand-name drugs in order to try to improve access to affordable medicines in the country.

Generics substitution: Ireland’s plan for reference pricing

Home/Policies & Legislation | Posted 21/09/2012

A bill that will be debated this autumn seeks to introduce generics substitution and reference pricing for medicines and medical and surgical appliances in Ireland.

India’s patent laws coming under repeated challenges

Home/Policies & Legislation | Posted 14/09/2012

India’s patent laws are being challenged by Big Pharma. Novartis is challenging India for denying the pharma giant a patent for Glivec (imatinib mesylate), its blockbuster cancer drug. While Bayer is challenging the Indian Government’s decision to grant a compulsory licence on its cancer drug Nexavar (sorafenib).

Malaysia objects to patent terms in free trade agreement

Home/Policies & Legislation | Posted 17/08/2012

Once again, the issue of patent protection and the periods of exclusivity given to originator pharmaceuticals (both small molecule and biological) has raised its ugly head in the negotiations for the Trans-Pacific Partnership (TPP) Free Trade Agreement. This time, the Malaysian Health Minister, Dr Datuk Seri Liow Tiong Lai, has spoken out against terms in the agreement which seek to extend the patent periods of medicines produced by foreign companies.

Is the end in sight for pay-for-delay?

Home/Policies & Legislation | Posted 17/08/2012

A Federal appeals court ruling may bring the US pharmaceutical industry before the Supreme Court. Will this put an end to a practice that is increasingly viewed as anticompetitive?

Rising tensions over drug pricing and patenting in India

Home/Policies & Legislation | Posted 10/08/2012

New developments in pricing and regulations of drugs in India mean that tensions are likely to mount over the coming months between international pharmaceutical interests and healthcare providers who are trying to improve access to affordable medicines.

Australia moves towards pricing policy for biosimilars

Home/Policies & Legislation | Posted 03/08/2012

The Australian Pharmaceuticals Industry Council (PIC) has agreed to a broad strategy for the pricing of biosimilars so as to encourage the development and entry of biosimilars into the market place.

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