Menu

Guidelines

Suffix V16F10

FDA increases number of biological suffix proposals

Home/Guidelines | Posted 10/06/2016

The US Food and Drug Administration (FDA) has announced a slight change to its guidance on naming biologicals, which will allow companies to propose up to 10 suffixes for each new biological or biosimilar. The agency announced the change in a Federal Register notice released on 2 June 2016.

09 AA008582

EMA releases reflection paper for generic oral immediate release products

Home/Guidelines | Posted 20/05/2016

The European Medicines Agency (EMA) announced on 13 May 2016 the publication of draft guidance on the dissolution requirements for orally administered generics with immediate release characteristics.

20 AA010933

FDA issues guidance on data integrity and GMP

Home/Guidelines | Posted 06/05/2016

The recent flood of data integrity problems identified at the manufacturing sites of drugmakers from India, China and elsewhere has led the US Food and Drug Administration (FDA) to draft new guidance addressing the issue.

Label FDA V14b20

FDA issues draft guidance on biosimilars labelling

Home/Guidelines | Posted 15/04/2016

The US Food and Drug Administration (FDA) announced on 31 March 2016 that it had issued draft guidance for industry on labelling for biosimilars. The guidance is open for comment for a period of two months.

India-Biotech Dept V13K29

India releases revised guidelines for ‘similar biologics’

Home/Guidelines | Posted 08/04/2016

On 26 March 2016, India’s Central Drugs Standard Control Organization (CDSCO) announced the release of proposed revised guidance for ‘similar biologics’ in India.

Guidance V13F21

EMA publishes guidance on publication of clinical trials data

Home/Guidelines | Posted 11/03/2016

The European Medicines Agency (EMA) announced on 3 March 2016 the publication of detailed guidance on the requirements for pharmaceutical companies to comply with the agency’s policy on publication of clinical trials data for medicines.

Remsima V14A10

BSG guidance recommends switching to biosimilar infliximab

Home/Guidelines | Posted 26/02/2016

The British Society of Gastroenterology (BSG) released new guidance in February 2016 recommending that stable patients be switched to biosimilar infliximab (CT-P13).

27 MD002442

FDA releases 47 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 19/02/2016

Generics makers have a whole host of new bioequivalence documents to go through. The US Food and Drug Administration (FDA) announced on 27 January 2016 that it had released 35 new draft guidance documents and 12 revisions to guidance documents on bioequivalence requirements for the development of generics containing 42 different active ingredients.

Review committee V15a16

FDA finalizes guidance for biosimilars meetings

Home/Guidelines | Posted 29/01/2016

The US Food and Drug Administration (FDA) announced on 18 November 2015 that it had finalized its guidance for industry on formal meetings between the FDA and biosimilars sponsors.

Canada V16A15

Health Canada issues draft revised SEB guideline

Home/Guidelines | Posted 15/01/2016

Canada’s federal department responsible for health, Health Canada, has issued a new draft revised guidance document on the information and submission requirements for subsequent entry biologics (SEBs). The draft guideline, issued on 7 December 2015, provides guidance to sponsors to enable them to satisfy the information and regulatory requirements under the Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

Guidance V13F21

EMA to revise biosimilar interferon alfa guidance

Home/Guidelines | Posted 08/01/2016

On 4 January 2016, the European Medicines Agency (EMA) released a draft concept paper on the revision of the reflection paper on non-clinical and clinical development of interferon alfa biosimilars. The draft will be released for a three-month consultation period by the pharmaceutical industry and competent authorities of the Member States, as well as by the Committee for Medicinal Products for Human Use (CHMP) and its working parties.

EMA logo 1 V13C15

EU guidelines for biosimilars

Home/Guidelines | Posted 08/10/2010

Last update: 8 January 2016

The regulatory body for approval of medicines in the European Union (EU) is the European Medicines Agency (EMA). The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

Generics Blue Cap V13C15

FDA issues final guidance on generics information requests

Home/Guidelines | Posted 11/12/2015

The US Food and Drug Administration (FDA) issued final guidance for generics makers on how to make formal requests for information. The final guideline, issued on 29 September 2015, provides information regarding the process by which generics makers can submit correspondence to FDA requesting information on generics development.

Guidance V13F21

India to revise ‘similar biologics’ guideline

Home/Guidelines | Posted 20/11/2015

The Indian Ministry of Health is planning to revise its guidelines for approving ‘similar biologics’. The ministry aims to make the regulatory pathway more robust and to align the guidelines further with global guidelines for biosimilars.

picture42

GPhA challenges FDA guidance on size and shape of generic pills

Home/Guidelines | Posted 30/10/2015

In June 2015, the US Food and Drug Administration (FDA) published guidance on the size, shape and other physical attributes of generic tablets and capsules [1]. However, the Generic Pharmaceutical Association (GPhA) has raised a number of concerns about the guidance.

Teamwork original

FDA to hold public meeting on reauthorization of BsUFA

Home/Guidelines | Posted 16/10/2015

The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Biosimilar User Fee Act (BsUFA) performance goals ahead of negotiations to reauthorize the law.

Guidance V13F21

FDA defends lack of biosimilars guidelines

Home/Guidelines | Posted 25/09/2015

The US Food and Drug Administration’s (FDA) director for the Center for Drug Evaluation and Research (CDER) Dr Janet Woodcock, told senators on 17 September 2015 that a critical part of launching a robust US biosimilars market and setting up the regulations to support it is to make sure the scientific framework is ‘bulletproof’.

Guidance V13F21

FDA issues draft guidance on naming biologicals

Home/Guidelines | Posted 04/09/2015

The US Food and Drug Administration (FDA) has issued another draft guidance for biosimilars. The draft guideline, issued on 27 August 2015, details the FDA’s proposal on the non-proprietary naming of biological products.

FDA logo V13C22

FDA releases 48 new and revised bioequivalence guidelines for generics

Home/Guidelines | Posted 21/08/2015

The US Food and Drug Administration (FDA) has released 44 new draft guidance documents and four revisions to guidance documents on bioequivalence requirements for the development of generics containing 46 different active ingredients. 

Generic Brand Name V13C01

FDA wants generics to be physically same as originators

Home/Guidelines | Posted 14/08/2015

Until now generics have been required to be pharmaceutically equivalent and bioequivalent to the brand-name drug, however, generics made by different manufacturers could differ substantially from their brand-name therapeutic equivalents and from each other in their physical appearance, e.g. colour, shape or size of pills. The US Food and Drug Administration (FDA), aims to change this, with guidance issued in June 2015 recommending that the physical properties, including the size, shape and colour, of generics should be similar to those of their reference drugs.

FDA logo V13C22

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 flag V13C29

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 logo 1 V13C15

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.

picture 80

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.