Egypt issues draft guidelines for biosimilars

Home/Guidelines | Posted 01/03/2013

The Egyptian Drug Authority (EDA) announced on 20 January 2013 that a draft guideline for the registration of biosimilars in Egypt had been released by the Central Administration for Pharmaceutical Affairs (CAPA) in coordination with the National Organization for Research & Control of Biologics (NORCB).

Draft revision of biosimilar low molecular weight heparin guideline

Home/Guidelines | Posted 08/02/2013

EMA announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs). The draft guideline will be released for a six-month public consultation period.

China’s SFDA to fast-track high-priority generics

Home/Guidelines | Posted 01/02/2013

China’s State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation and allowing the fast-track review of generic drugs which answer an unmet clinical need.

EMA publishes draft guideline for biosimilar human insulin

Home/Guidelines | Posted 11/01/2013

EMA announced on 14 December 2012 that it had published a draft guideline revising its current guideline on the non-clinical and clinical development of biosimilar human insulin and insulin analogues. The draft guideline will be released for a six-month public consultation period.

CESP makes submissions totally electronic

Home/Guidelines | Posted 14/12/2012

The Dutch Medicines Evaluation Board (CBG-MEB) announced on 1 November 2012 that starting from 12 November 2012, it will be possible to submit applications for marketing authorizations and deviations in the national, MRP (mutual recognition procedure) or DCP (decentralized procedure) procedures through the improved Common European Submission Platform (CESP).

China to release biosimilars guidelines

Home/Guidelines | Posted 23/11/2012

China, one of the largest pharmaceutical markets in the world, is ready to issue biosimilars guidelines.

Health Canada publishes draft GMP guideline for APIs

Home/Guidelines | Posted 09/11/2012

Health Canada announced on 22 October 2012 the publication of a draft guideline on good manufacturing practices (GMP) for active pharmaceutical ingredients (APIs).

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.