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Review committee V15a16

WHO asks for comments on new biosimilar Q&A

Home/Guidelines | Posted 14/09/2018

As part of plans to provide additional clarification of its 2009 guidelines on the evaluation of biosimilars, the World Health Organization (WHO) has drafted a new document providing answers to questions that regulators have posed over the past eight years.

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FDA issues final guidance on ANDA/PAS amendments

Home/Guidelines | Posted 31/08/2018

The US Food and Drug Administration (FDA) has issued final guidance outlining the agency’s review goals for amendments to abbreviated new drug applications (ANDAs) and prior approval supplements (PASs) under Generic Drug User Fee Amendments II (GDUFA II).

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FDA issues guidance for labelling biologicals and biosimilars

Home/Guidelines | Posted 24/08/2018

The US Food and Drug Administration (FDA) has issued two new guidance documents that provide recommendations to industry on labelling requirements for biologicals and biosimilars.

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FDA issues final guidance on biosimilar user fees

Home/Guidelines | Posted 20/07/2018

The US Food and Drug Administration (FDA) has issued final guidance on the agency’s Biosimilar User Fee Act (BsUFA) II fee structure finalizing the changes introduced since BsUFA I.

Guidance V13F21

FDA withdraws biosimilar statistical guidance

Home/Guidelines | Posted 06/07/2018

The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars. The agency does, however, plan to issue an amended version that ‘will reflect state-of-the-art techniques in the evaluation of analytical data’ and give sponsors ‘appropriate flexibility’.

Review committee V15a16

FDA issues draft guidance on biosimilar meetings

Home/Guidelines | Posted 29/06/2018

The US Food and Drug Administration (FDA) has issued new draft guidance that provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products.

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FDA issues guidance on quality considerations for inhaled drugs

Home/Guidelines | Posted 15/06/2018

The US Food and Drug Administration (FDA) has issued draft guidance on quality considerations for inhaled drugs.

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Global guidelines for biosimilars

Home/Guidelines | Posted 08/10/2010

Last update: 15 June 2018

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.

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FDA issues guidance on good manufacturing practice for APIs

Home/Guidelines | Posted 08/06/2018

The US Food and Drug Administration (FDA) has finalized revised guidance on good manufacturing practice (GMP) for active pharmaceutical ingredients (APIs).

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FDA issues final guidance on bioanalytical method validation

Home/Guidelines | Posted 25/05/2018

On 21 May 2018, the US Food and Drug Administration issued final guidance on bioanalytical method validation.

Regulation V13H16

TGA proposes changes to biologicals regulations

Home/Guidelines | Posted 18/05/2018

Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA) announced on 20 April 2018 the release of proposed amendments to its biologicals regulations that are set to take effect on 1 July 2018.

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Regulation of biologicals in Colombia

Home/Guidelines | Posted 20/04/2018

Since the introduction of Decree 1782 Colombia has been moving towards a new regulatory landscape for biologicals (productos bioterapéuticos) and similar biotherapeutic products (productos bioterapéuticos similares) in the country [1].

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EMA opens public consultation on GMP non-compliance template

Home/Guidelines | Posted 13/04/2018

The European Medicines Agency (EMA) announced on 3 April 2018 that it had opened a public consultation concerning the European Union (EU) template for good manufacturing practice (GMP) non-compliance statement.

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FDA releases 52 new and revised bioequivalence guidelines for generic drugs

Home/Guidelines | Posted 06/04/2018

As part of its ongoing efforts to provide product-specific guidance for generics makers the US Food and Drug Administration (FDA) has again released several new and revised bioequivalence documents. The agency announced on 1 February 2018 that it had released 35 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 49 different active ingredients.

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FDA issues guidance on co-crystals and impurities

Home/Guidelines | Posted 23/03/2018

The US Food and Drug Administration has finalized new guidance establishing co-crystals as a drug product intermediate. The agency has also released new information on when to submit elemental impurity data, acknowledging that new guidelines on reporting elemental impurities had slowed approvals in January 2018.

Review committee V15a16

China adopts ICH guidelines and collaborates with UK

Home/Guidelines | Posted 23/02/2018

As of 1 February 2018, the China Food and Drug Administration (CFDA) will be adopting five safety and regulatory guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). China became the eighth member of ICH in June 2017, which marked a significant expansion of ICH’s impact and aim to promote global public health.

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FDA agrees to meet GAO demands on revised guidance for complex generics

Home/Guidelines | Posted 09/02/2018

The US Government Accountability Office (GAO) released a report on 16 January 2018, in which it stated that the US Food and Drug Administration (FDA) should release plans to issue or revise guidance for complex generic drugs. FDA made an official response in which it laid out its plans for the future which address many of the GAO's concerns.

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China FDA issues draft guidance on drug review and approval transparency

Home/Guidelines | Posted 02/02/2018

China Food and Drug Administration (CFDA) announced on 16 January 2018 that it had issued draft guidance on the public disclosure of information related to its review and approval of drug applications.

Regulation V13H16

EMA regulatory guidance update to prepare for Brexit

Home/Guidelines | Posted 26/01/2018

In preparation for the UK’s withdrawal from the European Union (EU), set to take place on 29 March 2019, the European Medicines Agency (EMA) and the European Commission have issued regulatory guidance to pharmaceutical companies. The EU wants to ensure that pharmaceutical companies plan for Brexit to avoid any impact on the continuous supply of medicines within the EU.

ANDA Approval V13F21

FDA updates its list of drugs without generics

Home/Guidelines | Posted 12/01/2018

The US Food and Drug Administration (FDA) announced in December 2017 that it had updated its list of drugs without generics.

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FDA guidance aims to encourage abuse-deterrent generic opioids

Home/Guidelines | Posted 05/01/2018

The US Food and Drug Administration (FDA) has issued new guidance intended to encourage generics makers to make abuse-deterrent formulations of opioids.

TGA V13H23

Australian guidelines for biosimilars

Home/Guidelines | Posted 10/06/2011

Last update: 5 January 2018

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

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Indian guidelines for ‘similar biologics’

Home/Guidelines | Posted 07/12/2012

Last update: 5 January 2018

The regulatory bodies responsible for approval of ‘similar biologics’ in India are the Department of Biotechnology (DBT) under the Ministry of Science and Technology through its Review Committee on Genetic Manipulation (RCGM), and the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare.

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Stakeholders comment on FDA’s draft statistical biosimilarity guidance

Home/Guidelines | Posted 08/12/2017

The US Food and Drug Administration (FDA) released draft guidance on statistical approaches to evaluate similarity for biosimilars in September 2017 [1]. Comments from stakeholders on the guidance indicate that they want it to be more specific and narrower in scope.