EMA recommends suspension of drugs due to unreliable studies from Micro Therapeutic Research Labs
Medicines for which adequate alternative data are available may remain on the market
On 23 March 2017, the European Medicines Agency (EMA) recommended the suspension of a number of nationally approved medicines for which studies of bioequivalence were conducted by Micro Therapeutic Research Labs at two sites in India. The studies of biequivalence 
are usually the basis for the approval of generic drugs . It is available the list of drugs recommended for discontinuation. Suspensions can be lifted once alternative data establishing the are provided bioequivalence.
Alternative supporting data had already been anticipated for many of the drugs reviewed. Therefore, the Agency recommends that these drugs can remain on the market. L' list of recommended drugs to stay on the market it's available.
The Agency also recommended that medicines not yet authorized but being evaluated on the basis of studies of bioequivalence performed from these sites should not be authorized until the bioequivalence is not demonstrated using alternative data.
Micro Therapeutic Research Labs is a contract research organization (CRO), which conducts the analytical portions and clinical studies of bioequivalence, some of which are used to support themarketing authorisation of medicines in the EU.
Micro Therapeutic Research Labs Study Drug Review Initiated After Compliance Inspections of good clinical practice (GCP) by the Austrian and Dutch authorities in February 2016. Inspections identified several concerns at the company's sites regarding misrepresentation of study data and deficiencies in documentation and data management.
The review of the Committee for Medicinal Products for Human Use ( CHMP extension ) of EMA, 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 a marketing authorisation in the EU. However, there is no evidence of harm or lack of efficacy of medicines that are licensed and under evaluation in Europe, based on studies at the sites.
Some of the medicines that have been advised for suspension may be of critical importance (e.g. due to a lack of available alternatives) in some EU Member States. Therefore national authorities can temporarily postpone the suspension in the interest of patients. Member States also have to decide whether recalls of the affected medicines are necessary in their territories.
The recommendation of CHMP, regarding these medicines, it was sent to the European Commission, which issued a legally binding decision valid throughout the EU.
Related news: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs
