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Policies & Legislation

FDA and Health Canada streamline drug submissions

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

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

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

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

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

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

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

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.

FDA issues first warning letter for unpaid generics user fees

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.

India’s drug regulator finds no problem at Ranbaxy sites

India’s drug regulator has found no major discrepancies at the Mohali manufacturing unit of Ranbaxy Laboratories (Ranbaxy) in contrast to FDA findings.

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