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EMA publishes draft guideline for biosimilar human insulin

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

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).

Japanese guidelines for biosimilars

Last update: 18 January 2013

The Ministry for Health Labour and Welfare (MHLW) is the regulatory body in Japan responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in Japan and makes the decision on approval of drugs, including biologicals.

China to release biosimilars guidelines

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

Health Canada publishes draft GMP guideline for APIs

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

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

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

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

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

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.

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