Guidelines

Last update: 03 February 2012

The regulatory body for approval of medicines in the EU is EMA. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU. 

EMA announced on 20 January 2012 that it has published a draft guideline on how pharmaceutical companies should test biosimilar medicines containing interferon beta. The draft guideline is released for a four-month public consultation period. Feedback on the draft guideline can be submitted to EMA until the end of May 2012.

In October 2011, Chile’s Agencia Nacional de Medicamentos (ANAMED) released draft guidance for the evaluation of biosimilars in Chile

EMA announced on 17 November 2011 that it has published a concept paper asking for comments on topics to be included in a revision of the agency’s 2005 overarching guideline on similar biological medicinal products. The paper will be released for a three-month consultation period.

Last update: 18 November 2011

The regulatory body for approval of medicines of the EU is EMA.

When using a centralised procedure, which covers marketing authorisation for the whole of the EU, generic medicines are approved by its regulatory body, EMA.

Last update: 14 October 2011

The public health arm of the United Nations is World Health Organisation (WHO).

WHO via its biological standardisation programme develops guidelines and recommendations on the production and control of biological products and technologies.

Last update: 14 October 2011

The public health arm of the United Nations is World Health Organisation (WHO).

WHO provides guidelines in the area of quality assurance of pharmaceutical products. These guidelines are established and maintained through a consultative procedure and adopted by the WHO Expert Committee on Specifications for Pharmaceutical Preparations. They are submitted to the WHO’s governing bodies for endorsement and subsequent implementation by Member States.

The Ministry of Health Malaysia through the National Pharmaceutical Control Bureau (NPCB), which was set up in 1985, is the Malaysian authority that assures the quality of medicines in the country.

Since April 2001, the Health Sciences Authority (HSA, 卫生科学局), under the under the authority of the Ministry of Health of the Singapore Government, has been the Singapore authority that oversees all drug manufacturing, trade, and registration.

Since April 2001, the Health Sciences Authority (HSA) (Chinese: 卫生科学局), under the under the authority of the Ministry of Health of the Singapore Government, has been the authority that oversees all drug manufacturing, trade, and registration in Singapore.