Guidelines

US guidelines for generics

Home/Guidelines | Posted 26/11/2010

Last update: 14 August 2015

The regulatory body for approval of medicines in the US is the Food and Drug Administration (FDA).

Australia implements EMA’s biosimilars guidelines

Home/Guidelines | Posted 07/08/2015

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 3 June 2015 that it had adopted ten European Union (EU) guidelines in Australia.

EMA opens consultation on revision of biosimilar G-CSF guideline

Home/Guidelines | Posted 31/07/2015

On 27 July 2015, the European Medicines Agency (EMA) released a draft concept paper to discuss its planned revision of its specific guideline for biosimilars containing recombinant granulocyte colony-stimulating factor (G-CSF). The draft concept paper has been released for a three-month consultation period.

FDA outlines details of surveys into physical differences in generics

Home/Guidelines | Posted 26/06/2015

The US Food and Drug Administration (FDA) in a Federal Register notice published on 14 May 2015 has outlined how it will carry out pharmacist and patient surveys into how changes in the physical characteristics of generics pills affect patients’ perceptions.

Colombia issues further draft guidelines for biologicals

Home/Guidelines | Posted 12/06/2015

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 12 May 2015 the release of a new draft guideline on stability of biologicals in Colombia. The country also published a draft guideline on Good Manufacturing Practices (GMP) for biologicals on 17 April 2015.

FDA issues another biosimilars Q&A guidance

Home/Guidelines | Posted 22/05/2015

On 13 May 2015, the US Food and Drug Administration (FDA) issued another question and answer guidance document for biosimilar applications in the US. The draft guidance contains a question on the issue of interchangeability with reference biologicals.

Australia to adopt EMA’s biosimilars guidelines

Home/Guidelines | Posted 15/05/2015

The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 10 April 2015 that it was carrying out public consultations on the adoption of European Union (EU) guidelines in Australia.

FDA to hold public meeting on GDUFA

Home/Guidelines | Posted 08/05/2015

The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Generic Drug User Fee Act (GDUFA) performance goals and ways to improve procedures, ahead of negotiations to reauthorize the law.

FDA finalizes biosimilars guidelines

Home/Guidelines | Posted 04/05/2015

Three years after first issuing draft guidance on biosimilars, the US Food and Drug Administration (FDA) has finally issued three final guidelines for biosimilar applications in the US. The guidances, however, fail to address the issue of interchangeability with reference biologicals, which the agency says it will address in another document.

EMA rejects comparators from outside EEA for insulin biosimilars

Home/Guidelines | Posted 17/04/2015

The European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars in March 2015 [1]. However, while the guidance took into account many of the comments made by stakeholders on the second draft, the agency rejected requests to accept batches of reference (approved) biological products sourced from outside the European Economic Area (EEA).

FDA guidance on excipients questioned

Home/Guidelines | Posted 03/04/2015

The International Pharmaceutical Excipient Council of the Americas (IPEC-Americas) has written to the US Food and Drug Administration (FDA) outlining major concerns related to the agency’s guidance on inactive ingredients in abbreviated new drug applications (ANDAs).

EMA issues finalized insulin biosimilars guideline

Home/Guidelines | Posted 27/03/2015

In March 2015, the European Medicines Agency (EMA) released its finalized guideline on the non-clinical and clinical development of insulin biosimilars.

FDA plans to release four biosimilar guidances during 2015

Home/Guidelines | Posted 20/03/2015

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) is planning to release four new guidance documents on biosimilars during calendar year 2015.

Mexico issues rules on biolimbos

Home/Guidelines | Posted 13/03/2015

The Mexican regulatory body for approval of medicines, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), has issued rules for older non-originator biologicals registered prior to 19 October 2011, when the country’s guidelines for biocomparables were first published, mandating that companies conduct clinical trials to prove biosimilarity.

FDA calls for comment on generics user fees guidelines

Home/Guidelines | Posted 20/02/2015

The US Food and Drug Administration (FDA) announced in a Federal register publication of 6 February 2015 the reopening of the docket to solicit public comment on certain topics related to implementation of the Generic Drug User Fee Amendments of 2012 (GDUFA) and the GDUFA Commitment Letter that accompanies the legislation.

FDA calls for comment on biosimilars interchangeability

Home/Guidelines | Posted 06/02/2015

The US Food and Drug Administration (FDA) wants drugmakers to comment on the information requirements for biosimilars interchangeability.

FDA releases 53 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 30/01/2015

On 12 December 2014, the US Food and Drug Administration (FDA) released 31 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

Australia reviewing plans for naming biosimilars

Home/Guidelines | Posted 23/01/2015

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has changed its plans for naming biosimilars, ‘following recent international developments in the area of biosimilar naming’.

EMA issues revised guideline on non-clinical and clinical issues for biosimilars

Home/Guidelines | Posted 16/01/2015

On 18 December 2014, the European Medicines Agency (EMA) published the new version of its guideline addressing the non-clinical and clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. This new guideline will revise the agency’s 2006 overarching guideline on the non-clinical and clinical issues related to similar biological medicinal products.

FDA to carry out survey into affect of generics shape, colour, size

Home/Guidelines | Posted 28/11/2014

The US Food and Drug Administration (FDA) wants to understand how patients’ perceptions of medications change when pharmacies switch from brand-name to generic drugs or between the same generics made by different manufacturers and how this affects patient adherence to their medication.

China releases draft biosimilars guidance

Home/Guidelines | Posted 14/11/2014

On 29 October 2014 China’s Center for Drug Evaluation (CDE) published draft guidance for approval of biosimilars.

EMA issues revised version of overarching biosimilars guideline

Home/Guidelines | Posted 07/11/2014

On 29 October 2014, the European Medicines Agency (EMA) published the new version of its overarching biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products.

Concerns from EU and US over Colombian biologicals guidelines

Home/Guidelines | Posted 19/09/2014

On 21 January 2013, the Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) released a new draft guideline for biologicals, including 'productos bioterapéuticos similares' (similar biotherapeutic products), in Colombia [1]. Since then, both the European Union (EU) and the US have expressed concerns over the draft guidelines.

Generics group calls for say on ICH standards

Home/Guidelines | Posted 12/09/2014

The generics industry is somewhat annoyed at being excluded from the decision-making process of a global organization, which harmonizes drug quality, safety and efficacy standards.

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