Guidelines

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The US Food and Drug Administration (FDA) announced on 21 June 2018 that it had withdrawn the draft guidance on analytical studies of biosimilars.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’.

FDA issues draft guidance on biosimilar meetings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The US Food and Drug Administration (FDA) has issued new draft guidance that provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of biosimilar or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

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The US Food and Drug Administration (FDA) has issued draft guidance on quality considerations for inhaled drugs.

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.

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).

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.

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.

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].

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.

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.