Guidelines

The Common European Submission Platform

Home/Guidelines | Posted 12/10/2012

The Heads of Medicines Agencies (HMA) is currently carrying out an ‘extended proof of concept’ for the Common European Submission Platform (CESP) project aimed at establishing a single portal for electronic submissions to multiple competent authorities in the context of European registration and post-approval procedures in the European Economic Area.

EMA to accept biosimilar reference medicines from outside EEA

Home/Guidelines | Posted 05/10/2012

EMA announced on 28 September 2012 that it has adapted its guidance in order to make it easier for new biosimilar products to be approved in the EU. The changes in policy mean that EMA will accept clinical data from biosimilar medicines approved outside the European Economic Area (EEA).

India releases draft ‘similar biologic’ guidelines

Home/Guidelines | Posted 29/06/2012

India has released regulatory guidelines outlining a simple abridged procedure for evaluation of ‘similar biologics’ which have been approved and marketed in India, Europe or USA for more than four years.

Italian Medicines Agency publishes concept paper on biosimilars

Home/Guidelines | Posted 21/09/2012

The Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) announced on 1 August 2012 the release of a concept paper on biosimilars.

FDA finally issues draft biosimilar guidance

Home/Guidelines | Posted 17/02/2012

The long-awaited guidance for biosimilars in the US has finally arrived. FDA announced on 10 February 2012 that it had issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the US.

Singapore guidelines for generics

Home/Guidelines | Posted 05/08/2011

Last update: 10 August 2012

Since April 2001, the Health Sciences Authority (HSA, 卫生科学局), under the authority of the Ministry of Health of the Singapore Government, has been the Singapore authority that oversees all drug manufacturing, trade, and registration.

Singapore guidelines for biosimilars

Home/Guidelines | Posted 29/07/2011

Last update: 3 August 2012

Since April 2001, the Health Sciences Authority (HSA) (Chinese: 卫生科学局), under the authority of the Ministry of Health of the Singapore Government, has been the authority that oversees all drug manufacturing, trade, and registration in Singapore.

EMA finalises pharmacovigilance guidance

Home/Guidelines | Posted 06/07/2012

EMA announced on 25 June 2012 the release of the finalised versions of seven new guideline modules outlining good pharmacovigilance practices (GVPs) to assist sponsors with complying with the soon-to-be implemented pharmacovigilance (PV) legislation, which comes into effect on 2 July 2012.

New pharmaceutical law promotes generics in Chile

Home/Guidelines | Posted 24/08/2012

In July 2012, a new pharmaceutical law was introduced in Chile. The new law aims to regulate generics bioequivalence in the country as well as enforce prescription by generic name in order to increase the use of generics.