Micro Therapeutic Research

Current status:
European Commission final decision

Overview

EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs

Medicines where suitable alternative data are available can remain on market

On 23 March 2017, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India. Bioequivalence studies are usually the basis for approval of generic medicines. The PDF iconlist of medicines recommended for suspension is available. The suspensions can be lifted once alternative data establishing bioequivalence are provided.

Alternative supporting data had already been provided for several of the medicines reviewed. Therefore, the Agency recommended that these medicines could remain on the market. The PDF iconlist of medicines recommended to remain on the market is available.

The Agency also recommended that medicines not yet authorised but which were being evaluated on the basis of bioequivalence studies from these sites should not be authorised until bioequivalence is demonstrated using alternative data.

Micro Therapeutic Research Labs is a contract research organisation (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU.

The review of medicines studied by Micro Therapeutic Research Labs was started after inspections to check compliance with good clinical practice (GCP) by Austrian and Dutch authorities in February 2016. The inspections identified several concerns at the company's sites regarding misrepresentation of study data and deficiencies in documentation and data handling.

The review, by EMA's Committee for Medicinal Products for Human Use (CHMP), concluded that data from studies conducted at the sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorisation in the EU. However, there is no evidence of harm or lack of effectiveness of medicines authorised and being evaluated in the EU on the basis of studies at the sites.

Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in certain EU Member States. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States should also decide whether recalls of the affected medicines are needed in their territories.

The CHMP's recommendation concerning these medicines was sent to the European Commission, which issued a legally binding decision valid throughout the EU.

Key facts

Approved name
Micro Therapeutic Research
International non-proprietary name (INN) or common name
-
Class
-
Reference number
EMEA/H/A-31/1450
Type
Article 31 referrals

This type of referral is triggered when the interest of the Union is involved, following concerns relating to the quality, safety or efficacy of a medicine or a class of medicines.

Status
European Commission final decision
Opinion date
23/03/2017
EC decision date
23/06/2017

All documents

Document description

  • Questions and answers (Q&A) - easy-to-understand summary of key issues and Committee conclusions
  • Summary of Opinion - contains the CHMP opinion of the referred medicine(s)
  • List of the medicines affected by the referral (Annex I)
  • Scientific conclusions of the Committee (Annex II)

The following two documents are sometimes available:

  • Changes to the summary of product characteristics, labeling or package leaflet (also known as Annex III) - available when changes havebeen recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be takenfor the marketing authorisation(s) such as safety measures or extra studies

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