Policies & Legislation

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.

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.

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.

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 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].

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.

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.

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).

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.

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.