Micro Therapeutic Research

  • Procedure started
  • Under evaluation
  • CHMP opinion
  • European Commission final decision

Table of contents

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 icon list 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 icon list 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

About this medicine
Approved name
Micro Therapeutic Research
Class
-
About this procedure
Current status
European Commission final decision
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.
Key dates and outcomes
CHMP opinion date
23/03/2017
EC decision date
23/06/2017

All documents

Procedure started

  • List item

    Micro Therapeutic Research Article-31 referral - Annex I (PDF/1.01 MB)


    First published: 16/12/2016
    Last updated: 10/07/2017
    EMA/866024/2016 Rev. 3

  • List item

    Micro Therapeutic Research Article-31 referral - Review started (PDF/80.15 KB)


    First published: 16/12/2016
    Last updated: 16/12/2016
    EMA/850878/2016

  • List item

    Micro Therapeutic Research Article-31 referral - CHMP list of questions to be addressed by Micro Therapeutic Research Labs (PDF/69.4 KB)


    First published: 16/12/2016
    Last updated: 16/12/2016
    EMA/CHMP/302887/2016

  • List item

    Micro Therapeutic Research Article-31 referral - CHMP list of questions to be addressed by the applicants/marketing authorisation holders (PDF/69.38 KB)


    First published: 16/12/2016
    Last updated: 16/12/2016
    EMA/CHMP/847556/2016

  • List item

    Micro Therapeutic Research Article-31 referral - Timetable for the procedure (PDF/67.94 KB)


    First published: 16/12/2016
    Last updated: 16/12/2016
    EMA/CHMP/847557/2016

  • List item

    Micro Therapeutic Research Article-31 referral - Notification (PDF/1.73 MB)


    First published: 16/12/2016
    Last updated: 16/12/2016

    • Opinion provided by Committee for Medicinal Products for Human Use

    European Commission final decision

  • List item

    Micro Therapeutic Research Article-31 referral - CHMP assessment report (PDF/224.68 KB)


    First published: 10/07/2017
    Last updated: 10/07/2017
    EMA/420215/2017

  • List item

    Micro Therapeutic Research Article-31 referral - Annex II (PDF/49.15 KB)


    First published: 10/07/2017
    Last updated: 10/07/2017

  • List item

    Micro Therapeutic Research Article-31 referral - Annex III (PDF/25.96 KB)


    First published: 10/07/2017
    Last updated: 10/07/2017

    • Description of documents published

    Please note that some of the listed documents apply only to certain procedures.

    • Overview - lay-language summary of the stage of the procedure
    • Notification – a letter from a Member State, the European Commission or the marketing authorisation holder requesting the initiation of the procedure
    • Scientific background – further background information from the triggering Member State on the issues leading to the initiation of the procedure (if applicable)
    • List of questions – questions agreed by the Committee requesting further information from the marketing authorisation holder(s) / applicant(s) to evaluate the issues identified
    • Timetable for the procedure – agreed timeframe to respond to the list of questions, to assess the issues and to adopt a conclusion
    • List of medicines concerned by the procedure – medicine(s) / active substance(s) concerned, and marketing authorisation holder(s) / applicant(s)
    • List of questions to be addressed by the stakeholders – call for data to be submitted by stakeholders (e.g. healthcare professionals, patient organisations, individual patients) (if applicable)
    • Stakeholder submission form – form to be used by stakeholders to submit data (if applicable)
    • Scientific conclusions – scientific conclusions of the PRAC and/or CHMP and/or CMDh
    • Assessment report – PRAC or CHMP assessment and conclusions on the issues investigated, including divergent positions (if applicable)
    • Divergent positions – divergent positions of the CHMP or CMDh members for pharmacovigilance procedures (if applicable)
    • Changes to the summary of product characteristics, labelling and package leaflet (amended sections or fully revised version) (if applicable)
    • Condition(s) to the marketing authorisation(s) – condition(s) for the safe and effective use of the medicine(s) (if applicable)
    • Condition for lifting the suspension – condition to be fulfilled for the suspension of the marketing authorisation(s) to be lifted (if applicable)
    • Timetable for implementation of CMDh position – agreed timeframe to submit and finalise the variation(s) implementing the outcome of the procedure (if applicable)

    Note that older documents may have different titles.

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