Semler

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

Overview

 

EMA recommends suspension of medicines over flawed studies at Semler Research Centre

Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU

On 21 July 2016, the European Medicines Agency (EMA) recommended suspending a number of nationally approved medicines for which bioequivalence studies were conducted at Semler Research Centre Private Ltd, Bangalore, India. The Agency also recommended that medicines being evaluated for authorisation and which rely only on bioequivalence studies from this site should not be authorised until bioequivalence is demonstrated using alternative data. Bioequivalence studies usually form the basis for approval of generic medicines.

The PDF icon list of medicines recommended for suspension is available.

EMA's review followed an FDA inspection1 that identified several issues at Semler's bioanalytical site, including the substitution and manipulation of subjects' clinical samples. The World Health Organization (WHO) also raised serious concerns2 regarding data integrity and manipulation of study samples following its own inspections of Semler's bioanalytical and clinical sites.

The findings from FDA and WHO inspections called into question the quality management system in place at Semler, and thus the reliability of the data of all bioequivalence studies, including those used to support marketing authorisation applications in the EU. EMA's Committee for Medicinal Products for Human Use (CHMP) concluded that the studies conducted at Semler cannot be accepted in marketing authorisation applications in the EU. Thus, no medicines can be approved on the basis of these studies.

During the evaluation, alternative studies were provided for some of these medicines. These studies show bioequivalence, and therefore, the CHMP recommended that these medicines can remain on the market. The PDF icon list of medicines recommended to remain on the market is available.

Some of the medicines which have been recommended for suspension may be of critical importance (e.g. due to lack of available alternatives) in a given EU Member State. 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 for a legally binding decision valid throughout the EU.


1FDA notification to Pharmaceutical Companies: Clinical and Bioanalytical Studies Conducted by Semler Research Are Unacceptable.

2WHO pre-qualification team - Inspections Services - Notice of concern.

Key facts

About this medicine
Approved name
Semler
About this procedure
Current status
European Commission final decision
Reference number
EMEA/H/A-31/1443
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
21/07/2016
EC decision date
22/09/2016

All documents

Procedure started

  • List item

    Semler Article-31 referral – Annex IA and IB (PDF/276.65 KB)


    First published: 03/05/2016
    Last updated: 17/11/2016
    EMA/314147/2016 Corr. 6

  • Opinion provided by Committee for Medicinal Products for Human Use

  • List item

    Semler Article-31 referral – EMA recommends suspension of medicines over flawed studies at Semler Research Centre (PDF/90.43 KB)


    First published: 22/07/2016
    Last updated: 17/11/2016
    EMA/489380/2016

  • European Commission final decision

  • List item

    Semler Article-31 referral – CHMP assessment report (PDF/159.75 KB)


    First published: 17/11/2016
    Last updated: 17/11/2016
    EMA/633696/2016

  • List item

    Semler Article-31 referral – Annex II (PDF/45.58 KB)


    First published: 17/11/2016
    Last updated: 17/11/2016

  • List item

    Semler Article-31 referral – Annex III (PDF/18.9 KB)


    First published: 17/11/2016
    Last updated: 17/11/2016

  • 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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