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Proposal in Brazil to exempt medicines from tax

Home/Policies & Legislation | Posted 21/03/2014

The Brazilian Government announced on 9 February 2014 that it is setting up a committee to evaluate whether to exempt medicines from tax in the country.

Teamwork original

EMA and FDA extend quality collaboration

Home/Policies & Legislation | Posted 14/03/2014

The European Medicines Agency (EMA) announced on 6 March 2014 that as of 1 April 2014 EMA and the US Food and Drug Administration (FDA) have agreed on a two-year extension of their joint pilot programme for the parallel evaluation of quality elements, known as quality-by-design (QbD), for applications submitted to both agencies.

Pharmacovigilance V13F21

European trade organizations worried about pharmacovigilance fees

Home/Policies & Legislation | Posted 07/03/2014

Some of Europe’s major trade associations have expressed their concerns over fees being proposed by the European Medicines Agency (EMA) as part of new European Union (EU) pharmacovigilance rules.

Shaking hands V13D29

FDA and Health Canada streamline drug submissions

Home/Policies & Legislation | Posted 28/02/2014

The US Food and Drug Administration (FDA) and Health Canada have joined forces to launch the Common Electronic Submissions Gateway. Drug companies will be able to use the gateway to send drug authorization data online using a special dedicated channel of FDA’s existing system.

Regulation V13H16

Washington State legislation on biosimilars

Home/Policies & Legislation | Posted 07/02/2014

Biologicals manufacturers represented by the Biotechnology Industry Association (BIO) and the Washington Biotechnology & Biomedical Association have welcomed proposed Washington State legislation that will support the substitution of interchangeable biological medicines.

Brazil flag V13C03

Brazil to designate medicamentos similares as interchangeable

Home/Policies & Legislation | Posted 24/01/2014

Medicamentos similares (similar medicines) may soon be substituted with the reference drug in Brazil, under the latest initiative launched by the country’s National Health Surveillance Agency [Agência Nacional de Vigilância Sanitária, ANVISA].

Checklist V14A17

EMA and FDA launch joint generics inspections

Home/Policies & Legislation | Posted 17/01/2014

The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will work together to ensure the safety of generic medicines. It is hoped that streamlining the inspection process for generic drug applications will help consumers gain access to safe and effective generics.

Law V13C29

Pennsylvania moves closer to adopting biosimilars legislation

Home/Policies & Legislation | Posted 29/11/2013

Pennsylvania has taken a step closer to adopting legislation which would authorize pharmacists to be able to substitute FDA-approved biosimilars for their reference biologicals, but with certain restrictions.

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Biologicals in EU to be identified by brand names

Home/Policies & Legislation | Posted 22/02/2013

The European Commission has issued a directive, which requires biological products to be identified by brand name and not by international nonproprietary name (INN).

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FDA to allow generics makers to change labelling

Home/Policies & Legislation | Posted 22/11/2013

On 8 November 2013 the US Food and Drug Administration (FDA) announced that it had published its proposed rule allowing generics makers to change their labelling in the Federal Register.

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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.

User Fee V13H23

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.

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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 V13I20

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.

Patent 1 V13E17

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.

Pay for Delay V13C29

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.

Generic V13C05

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.

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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.

Law V13C29

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.