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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 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 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.

Information for patients and healthcare professionals
  • A number of medicines for use in the EU were approved based on studies carried out at two Micro Therapeutic Research Labs sites in India. The studies are unreliable because of problems in the way data and documents were managed at the sites. As a result, several medicines approved in the EU have been suspended.
  • The list of medicines recommended for suspension is available.
  • There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Micro Therapeutic Research Labs.
  • Several medicines which were approved on the basis of studies conducted at Micro Therapeutic Research Labs can remain on the market in the EU. This is because during this review, alternative data were provided for these medicines.
  • The list of medicines recommended to remain on the market is available.
  • National authorities in the EU will consider how critical individual medicines recommended for suspension are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
  • Patients should continue to take their medicines as prescribed and contact their doctors in case of questions or concerns.
More about the medicines

The review covered one medicine authorised centrally through EMA (Tadalafil Mylan), as well as medicines authorised by national procedures in EU Member States (including decentralised or mutual recognition procedures), whose marketing authorisation applications included data from studies conducted by Micro Therapeutic Research Labs at two sites in India:

  • Micro Therapeutic Research Labs Pvt. Ltd Rajam Bhavanam, No. 6, Kamarajar Salai, Selaiyur, East Tambaram, Chennai-600 059, Tamil Nadu.
  • Micro Therapeutic Research Labs, No. 29 A, Krishna Madhuravanam, Vellokinar Pirivu, Thudiyalur, Coimbatore-641 029, Tamil Nadu.

The review also included ongoing marketing authorisation applications for medicines which use study data from these sites.

More about the procedure

The review was initiated on 15 December 2016 by several medicines regulatory agencies – Austria, Bulgaria, Croatia, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Latvia, the Netherlands, Norway, Romania, Slovakia, Slovenia, Spain, Sweden and the United Kingdom - under Article 31 of Directive 2001/83/EC.

The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for all questions concerning medicines for human use, which adopted its opinion. The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 23 June 2017.

Key facts

Approved nameMicro Therapeutic Research
International non-proprietary name (INN) or common name

-

Associated names-
Class-
Reference numberEMEA/H/A-31/1450
TypeArticle 31 referrals

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

StatusEuropean Commission final decision
Opinion date23/03/2017

All documents

Name Language First published Last updated
Micro Therapeutic Research Article-31 referral - EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs (English only) 2017-03-24 2017-07-10
Micro Therapeutic Research Article-31 referral - CHMP assessment report (English only) 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex I BG = bălgarski 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I ES = español 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I CS = čeština 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I DA = dansk 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I DE = Deutsch 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I ET = eesti keel 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I EL = elliniká 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I EN = English 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I FR = français 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I IT = italiano 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I LV = latviešu valoda 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I LT = lietuvių kalba 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I HU = magyar 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I MT = Malti 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I NL = Nederlands 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I PL = polski 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I PT = português 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I RO = română 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I SK = slovenčina 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I SL = slovenščina 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I FI = suomi 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I SV = svenska 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex I HR = Hrvatski 2016-12-16 2017-07-10
Micro Therapeutic Research Article-31 referral - Annex II BG = bălgarski 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II ES = español 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II CS = čeština 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II DA = dansk 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II DE = Deutsch 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II ET = eesti keel 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II EL = elliniká 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II EN = English 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II FR = français 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II IT = italiano 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II LV = latviešu valoda 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II LT = lietuvių kalba 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II HU = magyar 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II MT = Malti 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II NL = Nederlands 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II PL = polski 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II PT = português 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II RO = română 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II SK = slovenčina 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II SL = slovenščina 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II FI = suomi 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II SV = svenska 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex II HR = Hrvatski 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III BG = bălgarski 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III ES = español 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III CS = čeština 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III DA = dansk 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III DE = Deutsch 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III ET = eesti keel 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III EL = elliniká 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III EN = English 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III FR = français 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III IT = italiano 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III LV = latviešu valoda 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III LT = lietuvių kalba 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III HU = magyar 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III MT = Malti 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III NL = Nederlands 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III PL = polski 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III PT = português 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III RO = română 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III SK = slovenčina 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III SL = slovenščina 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III FI = suomi 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III SV = svenska 2017-07-10  
Micro Therapeutic Research Article-31 referral - Annex III HR = Hrvatski 2017-07-10  
Micro Therapeutic Research Article-31 referral - Medicinal products recommended for maintenance and marketing authorisation applications for which bioequivalence vis-à-vis the EU reference medicinal product has been established as adopted by the CHMP on 23 March 2017 (English only) 2017-03-24 2017-04-19
Micro Therapeutic Research Article-31 referral - Review started (English only) 2016-12-16  
Micro Therapeutic Research Article-31 referral - CHMP list of questions to be addressed by Micro Therapeutic Research Labs (English only) 2016-12-16  
Micro Therapeutic Research Article-31 referral - CHMP list of questions to be addressed by the applicants/marketing authorisation holders (English only) 2016-12-16  
Micro Therapeutic Research Article-31 referral - Timetable for the procedure (English only) 2016-12-16  
Micro Therapeutic Research Article-31 referral - Notification (English only) 2016-12-16  

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 have been recommended by the Committee
  • Conditions of the marketing authorisation (also known as Annex IV) - available when the Committee recommends measures to be taken for the marketing authorisation(s) such as safety measures or extra studies

Current status:
European Commission final decision

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