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Generics reform in Korea

Home/Guidelines | Posted 31/07/2020

The Korean Ministry of Food and Drug Safety (MFDS) has taken action to improve the quality of generic drug products and ensure an efficient and competitive generics market.

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EMA and HMA release joint network strategy to 2025

Home/Guidelines | Posted 17/07/2020

The European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have released a draft joint network strategy for the coming five years. A public consultation on the strategy will be open for two months.

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FDA issues guidance on hydroxychloroquine, chloroquine

Home/Guidelines | Posted 04/05/2020

The US Food and Drug Administration (FDA) has released new guidance on hydroxychloroquine and chloroquine, which have been raised by President Trump as treatments for coronavirus, despite limited evidence.

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China publishes draft guideline for denosumab copy biologicals

Home/Guidelines | Posted 22/05/2020

Another specific guidance for makers of copy biologicals has been published by China’s Center for Drug Evaluation (CDE). This time the guidance covers denosumab.

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China’s drug agency proposes changes to patent law

Home/Guidelines | Posted 02/10/2020

China’s National Medical Products Administration (NMPA) has published proposed regulation on patent linkage, which would be similar to the Hatch-Waxman Act in the US.

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China publishes draft guideline for trastuzumab copy biologicals

Home/Guidelines | Posted 15/05/2020

China’s Center for Drug Evaluation (CDE) has published yet more specific guidance for makers of copy biologicals in the country, this time for trastuzumab.

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China publishes draft guideline for bevacizumab copy biologicals

Home/Guidelines | Posted 08/05/2020

On 7 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of bevacizumab copy biologicals. This guidance is the second specific guideline released by the CDE in April. The agency also released guidance on adalimumab on 1 April 2020 [1].

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China publishes draft guideline for adalimumab copy biologicals

Home/Guidelines | Posted 24/04/2020

On 1 April 2020, China’s Center for Drug Evaluation (CDE) published draft guidance on clinical trials for the approval of adalimumab copy biologicals.

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Guidelines released on USAN naming

Home/Guidelines | Posted 10/04/2020

The American Medical Association (AMA) has issued guidelines on naming using United States Adopted Names (USAN), which are unique non-proprietary names assigned to pharmaceuticals sold in the US.

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FDA opens pathway to biosimilar insulin products

Home/Guidelines | Posted 03/04/2020

On 23 March 2020, insulin products in the US transitioned to a new regulatory pathway which will allow biosimilars to be developed. The change should make insulin products more affordable for American citizens.

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FDA to transition NDAs to BLAs

Home/Guidelines | Posted 27/03/2020

The US Food and Drug Administration (FDA) is soon to transition many new drug applications (NDAs) to biologicals license applications (BLAs), with significant implications for biotechnology companies and drug compounders.

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Comments criticize FDA guidance on insulin biosimilars

Home/Guidelines | Posted 20/03/2020

Eli Lilly and Novo Nordisk have submitted critical comments on the US Food and Drug Administration’s (FDA) draft guidance on insulin biosimilars, which suggests that immunogenicity testing may not be necessary for all products.

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FDA issues new rule on definition of term ‘biological product’

Home/Guidelines | Posted 06/03/2020

The US Food and Drug Administration (FDA) announced on 20 February 2020 that it had issued a final rule on the definition of the term ‘biological product’.

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FDA issues new guidance for biosimilar user fees

Home/Guidelines | Posted 28/02/2020

The US Food and Drug Administration (FDA) has issued final guidance on the structure of the agency’s user fee programme under the Biosimilar User Fee Act of 2017 (BsUFA II).

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FDA issues draft guidance on labelling and advertising of biologicals

Home/Guidelines | Posted 21/02/2020

The US Food and Drug Administration (FDA) has issued a draft guidance on labelling and advertising of biologicals, including biosimilars.

Guidance V13F21

FDA issues draft guidance on licensing biosimilars for fewer indications

Home/Guidelines | Posted 14/02/2020

The US Food and Drug Administration (FDA) announced in February 2020 that it had issued draft guidance on getting approval for biosimilars for just some of the approved indications of the originator biological.

Guidance V13F21

UK medicines agency releases no-deal Brexit guidance

Home/Guidelines | Posted 10/01/2020

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on how to source comparator products for generic drug applications in the event of a no-deal Brexit.

Guidance V13F21

FDA issues updated guidance on implementing GDUFA II

Home/Guidelines | Posted 13/12/2019

The US Food and Drug Administration (FDA) has revised and replaced its draft guidance on implementing the Generic Drug User Fee Amendments of 2017 (GDUFA II).

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Health Canada publishes biosimilars fact sheet

Home/Guidelines | Posted 06/12/2019

Health Canada has published a fact sheet on biosimilars, which aims to provide a comprehensive overview on a number of issues concerning biosimilars.

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FDA issues draft guidance for insulin biosimilars

Home/Guidelines | Posted 29/11/2019

The US Food and Drug Administration (FDA) announced on 25 November 2019 that it had issued draft guidance on immunogenicity considerations for insulin biosimilars.

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EC publishes biosimilar information for healthcare professionals in 23 languages

Home/Guidelines | Posted 08/11/2019

The European Commission (EC) and the European Medicines Agency (EMA) have published an information guide on biosimilars aimed at healthcare professionals in 23 languages.

ANDA Approval V13F21

FDA issues final guidance on petitions delaying generics

Home/Guidelines | Posted 08/11/2019

The US Food and Drug Administration (FDA) announced on 18 September 2019 that it had issued final guidance to address ‘gaming’ by the use of citizen petitions.

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US guidelines for biosimilars

Home/Guidelines | Posted 12/11/2010

Last update: 25 October 2019

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

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FDA planning more guidance for developers of complex generics

Home/Guidelines | Posted 18/10/2019

As part of its efforts to advance the development of generics of complex drugs with the aim of improving patient access to medicines, the US Food and Drug Administration (FDA) announced that it is planning to release new and revised guidance documents for complex generics.