Home / Guidelines

Guidelines

Proposed biosimilars guidelines for Chile

In October 2011, Chile’s Agencia Nacional de Medicamentos (ANAMED) released draft guidance for the evaluation of biosimilars in Chile

EMA to revise overarching biosimilar guidelines

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.

EU guidelines for generics

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.

Malaysian guidelines for biosimilars

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.

Malaysian guidelines for generics

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.

FDA hearing on biosimilars: focus on characterisation and clinical trials

A 2-day public meeting was held by the FDA on 2–3 October 2010 at Silver Spring, Maryland, USA, in order to obtain input on specific issues and challenges associated with the implementation of a biosimilars pathway as part of the BPCI Act. The discussions at the meeting focussed on the challenges associated with characterisation of such complex molecules and what clinical trials would be appropriate [1].

Australian guidelines for generics

Last update: 1 July 2011

The regulatory body for therapeutic goods in Australia is the Therapeutic Goods Administration (TGA).

Japanese guidelines for generics

Last update: 1 July 2011

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs [1].

US biosimilars pathway unlikely to be used

Healthcare reform in the US was brought into force by the Patient Protection and Affordable Care Act (amended by the Health Care and Education Reconciliation Act) and was signed into law on 23 March 2010 by President Barack Obama.

Regulatory recommendations for biosimilars in the EU

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

The EU has developed a general legal pathway, and the EMA has developed regulatory guidelines, for the approval of biosimilars (see below).

Generics News Research General

more

Biosimilars News Research General

more