{"id":30498,"date":"2017-03-28T11:31:21","date_gmt":"2017-03-28T09:31:21","guid":{"rendered":"http:\/\/www.fedaiisf.it\/?p=30498"},"modified":"2017-04-07T11:52:26","modified_gmt":"2017-04-07T09:52:26","slug":"ema-raccomanda-la-sospensione-342-farmaci-generici-linaffidabilita-degli-studi-indiani-bioequivalenza","status":"publish","type":"post","link":"https:\/\/www.fedaiisf.it\/en\/ema-raccomanda-la-sospensione-342-farmaci-generici-linaffidabilita-degli-studi-indiani-bioequivalenza\/","title":{"rendered":"EMA recommends the suspension of 342 generic medicines due to the unreliability of Indian bioequivalence studies. Ed"},"content":{"rendered":"

EMA recommends drug suspension due to unreliable studies from Micro Therapeutic Research Labs<\/span><\/h2>\n

EMA \u2013 Press Release \u2013 03\/24\/2017<\/span><\/a><\/p>\n

The European Medicines Agency (EMA) has recommended the suspension of a number of nationally approved medicines for which studies of\u00a0bioequivalence<\/span>\u00a0were conducted by Micro Therapeutic Research Labs at two sites in India. The studies of biequivalence<\/span><\/span>\u00a0are usually the basis for the approval of <\/span>generic drugs<\/span><\/span><\/p>\n

L' list of recommended medications for discontinuation can be found here<\/a><\/span> . Suspensions can be lifted once alternative data has been established\u00a0bioequivalence<\/span>.<\/p>\n

d\"ImmagineAlternative support data have already been provided for many of the drugs reviewed. Therefore, the <\/span>CHMP has<\/span><\/span> recommended that these drugs can remain on the market. <\/span>L' list of recommended drugs to stay on the market is available here<\/a><\/span> .<\/p>\n

The Agency also recommended that medicines not yet authorized but which are being evaluated based on studies of\u00a0<\/span>bioequivalence<\/span><\/span>\u00a0carried out by these Indian sites should not be allowed until the\u00a0<\/span>bioequivalence<\/span><\/span>\u00a0is not demonstrated by alternative data.<\/span><\/p>\n

Micro Therapeutic Research Labs is a contract research organization (CRO), which conducts portions of analytical and clinical studies of <\/span>bioequivalence<\/span><\/span>, some of which are used to support the<\/span>marketing authorisation<\/span><\/span>\u00a0of medicines in the EU.<\/span><\/p>\n

The review of the drugs studied by Micro Therapeutic Research Labs was initiated after inspections carried out by the Austrian and Dutch authorities in February 2016 to verify compliance <\/span>of good clinical practice<\/span><\/span> (GCP). Inspections identified several concerns at the Indian company's sites regarding misrepresentation of study data and deficiencies in documentation and data management.<\/span><\/p>\n

The review carried out by\u00a0<\/span>Committee for Medicinal Products for Human Use<\/span><\/span> (<\/span>CHMP extension<\/span><\/span>) of EMA, concluded that data from studies conducted at Indian sites between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for <\/span>a marketing authorisation\u00a0<\/span><\/span>in the EU. <\/span>However, there is no evidence of harm or lack of efficacy of medicines licensed and under evaluation in Europe, based on studies at Indian sites.<\/p>\n

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. <\/span>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.<\/p>\n

There<\/span>\u00a0CHMP recommendation regarding these medicines will now be sent to the European Commission for a legally binding decision valid throughout the EU.<\/span><\/p>\n

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Information for patients and healthcare professionals<\/strong><\/p>\n