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Generics applications under review by EMA – April 2014

Generic medicines in Europe can be approved either centrally via the European Medicines Agency (EMA) or nationally via the local regulatory body [1]. Approval by EMA takes place by using a centralized procedure. This leads to approval of the product in all 28 European Union (EU) Member States and in Iceland, Liechtenstein and Norway. At a country level, if approval in a single EU Member State only is required, this can take place using the national procedure. However, as soon as a company seeks approval in two or more Member States, a decentralized procedure or mutual recognition procedure must be used [2].

UK launches generic medicines forum

The UK’s drug regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) announced on 16 April 2014 the launch of a new forum to promote the manufacturing quality of generics.

FDA defends generics labelling proposal

The US Food and Drug Administration’s (FDA) Director of the Center for Drug Evaluation and Research, Dr Janet Woodcock, testified before the Subcommittee on Health, Committee on Energy and Commerce of the US House of Representatives on 1 April 2014, to discuss FDA’s proposed labelling rule for generics.

Results of clinical trials in Europe to be made publicly available

It will soon be the law in Europe for all clinical drug trials to be registered and the results reported on a publicly-accessible database. Members of the European Parliament (MEPs) voted on 2 April 2014 by a huge majority to adopt the Clinical Trials Regulation, 547 in favour, 17 against and 13 abstaining.

FDA discredits study claiming foreign generics tainted

Research suggesting that foreign generics are inferior to US generics has been discredited by the FDA’s Center for Drug Evaluation and Research Director Dr Janet Woodcock.

EGA calls for removal of competition and trade barriers for generics

The European Generic medicines Association (EGA) is calling on the EU to remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules.

FDA increases oversight of drug safety in India

The US Food and Drug Administration (FDA) has created an Office of Pharmaceutical Quality in response to quality concerns at home and abroad, particularly surrounding generic medicines from several Indian manufacturing plants [1].

Brand-name drugs also cut healthcare costs

Generics are often given all the praise when it comes to cutting costs for patients and payers, but, according to a piece in Forbes, brand-name drugs also cut healthcare costs.

FDA starts widespread testing of generics

The US Food and Drug Administration (FDA) has allocated US$20 million for testing generics and has already been assessing generics since September 2013, despite no announcement having been made.

Rising generics use triggers increased worldwide regulation

The increasing use of lower cost generics is prompting regulators across the globe to introduce stricter regulations focusing on the quality of these products.

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