Guidelines

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 The agency announced on 1 February 2018 that it had released 35 new draft guidance documents and 22 revisions to guidance documents on bioequivalence requirements for the development of generics containing 49 different active ingredients.

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

FDA publishes new draft guidance for ADHD generic

Home/Guidelines | Posted 24/11/2017

In October 2017, the US Food and Drug Administration (FDA) issued new product-specific draft guidance for generic methylphenidate oral extended-release tablets.

India updates its similar biologics guidelines

Home/Guidelines | Posted 10/11/2017

The Indian Ministry of Health has revised its guidelines for approving ‘similar biologics’. The guideline was updated in order to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars. The update was seen as essential in order to meet the ‘ever changing global standards’.

FDA releases 52 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 03/11/2017

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 18 October 2017 that it had released 33 new draft guidance documents and 19 revisions to guidance documents on bioequivalence requirements for the development of generics containing 47 different active ingredients.

New guidelines expected to encourage generics in China

Home/Guidelines | Posted 27/10/2017

New guidelines have been finalized in China to try and make the country a more drug-friendly market, while also promising progress in the use of generics.

FDA draft guidance clarifies when a 505(b)2 application can be submitted

Home/Guidelines | Posted 20/10/2017

The US Food and Drug Administration (FDA) has issued new draft guidance intended to help companies determine whether to submit an abbreviated new drug application (ANDA), i.e. 505(j), or a 505(b)(2) application.

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