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Global guidelines for generic medicines

Home/Guidelines | Posted 20/10/2010

Last updated: 23 April 2012

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.

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FDA issues drug shortage draft guidance

Home/Guidelines | Posted 02/03/2012

FDA announced on 21 February 2012 the release of drug shortage draft guidance for industry in order to increase the supply of critically needed cancer drugs. The announcement follows an Executive Order signed by US President Barack Obama in October 2011 in an attempt to resolve escalating shortages of life-saving medicines [1].

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Interchangeability not covered in FDA draft biosimilar guidance

Home/Guidelines | Posted 17/02/2012

FDA has finally issued draft guidance documents for biosimilars. However, the guidelines still do not address the issue of interchangeability of originator drugs and biosimilars.

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EMA publishes draft biosimilar guideline for interferon beta

Home/Guidelines | Posted 27/01/2012

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.

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Proposed biosimilars guidelines for Chile

Home/Guidelines | Posted 20/01/2012

In October 2011, Chile’s Agencia Nacional de Medicamentos (ANAMED) released draft guidance for the evaluation of biosimilars in Chile

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EMA to revise overarching biosimilar guidelines

Home/Guidelines | Posted 09/12/2011

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.

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EU guidelines for generics

Home/Guidelines | Posted 08/10/2010

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.

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Malaysian guidelines for biosimilars

Home/Guidelines | Posted 05/08/2011

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.

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Malaysian guidelines for generics

Home/Guidelines | Posted 29/07/2011

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.

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FDA hearing on biosimilars: focus on characterisation and clinical trials

Home/Guidelines | Posted 08/07/2011

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].

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Australian guidelines for generics

Home/Guidelines | Posted 24/06/2011

Last update: 1 July 2011

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

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Japanese guidelines for generics

Home/Guidelines | Posted 24/06/2011

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].

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US biosimilars pathway unlikely to be used

Home/Guidelines | Posted 18/03/2011

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

Home/Guidelines | Posted 30/07/2010

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).

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Saudi Arabian guidelines for biosimilars

Home/Guidelines | Posted 08/07/2011

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade, and registration in Saudi Arabia.

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Saudi Arabian guidelines for generics

Home/Guidelines | Posted 01/07/2011

The Saudi Food and Drug Authority (SFDA) is the authority that oversees all drug manufacturing, trade and registration in Saudi Arabia.

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FDA to release guidance on generic tablet size

Home/Guidelines | Posted 17/06/2011

The FDA hopes to release guidance in the next few months to help generic drug makers understand how big or small their tablet or capsule can be compared to the branded equivalent, an agency official said.

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FDA issues new bioequivalence guidance for generics

Home/Guidelines | Posted 06/06/2011

In May 2011, the FDA issued new guidance for the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). This new guidance means that all bioequivalence data will now have to be submitted, including failed studies.

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EMA, FDA and TGA joint GMP inspection programme

Home/Guidelines | Posted 13/05/2011

On 27 April 2011, the FDA announced that it is working with the EMA and Australia’s Therapeutic Goods Administration (TGA) to finalise a permanent pilot programme for joint good manufacturing practice (GMP) inspections at active pharmaceutical ingredient (API) manufacturing facilities.

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FDA and EMA to join forces on quality

Home/Guidelines | Posted 29/04/2011

EMA and FDA have launched on 1 April 2011 a three-year pilot programme to allow parallel evaluation of quality elements, known as Quality by Design (QbD), of selected applications submitted to both agencies at the same time.

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China’s regulatory authority adopt CTD format for NDAs

Home/Guidelines | Posted 25/03/2011

On 25 September 2010, China’s State Food and Drug Administration (SFDA) issued new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.

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EMA adopts guideline on biosimilar monoclonal antibodies

Home/Guidelines | Posted 11/02/2011

EMA announced on its website that it has adopted the long-anticipated guideline on biosimilar monoclonal antibodies.

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India regulatory authority to adopt CTD format for NDAs

Home/Guidelines | Posted 11/02/2011

On 28 October 2010, India’s Central Drugs Standard Control Organization (CDSCO) released new guidance for industry for submission of new drug applications (NDAs) in the common technical document (CTD) format.

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The FDA’s 2010 final rule and draft guidance

Home/Guidelines | Posted 04/02/2011

In an effort to improve safety detection, the FDA issued a final rule and draft guidance on 29 September 2010 to clarify the requirements governing safety reporting requirements for human drug and biological products subject to an investigational new drug (IND) application.