Medicine recalls
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| European Union: EMA recommends suspension of medicines due to unreliable studies from Micro Therapeutic Research Labs |
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The European Medicines Agency (EMA) has 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 suspensions can be lifted once alternative data establishing bioequivalence are provided. There are totally 328 products of 30 active ingredients / combinations of active ingredients are affected. The list of medicines recommended for suspension can be found at
http://www.ema.europa.eu/docs/en_GB/../WC500224406.pdf
Alternative supporting data have already been provided for several of the medicines reviewed. Therefore, the Committee for Medicinal Products for Human Use (CHMP) recommended that these medicines can remain on the market. The list of medicines recommended to remain on the market is available at:
http://www.ema.europa.eu/docs/en_GB/../WC500224405.pdf
The Agency also recommended that medicines not yet authorized but which are being evaluated on the basis of bioequivalence studies from these sites should not be authorized until bioequivalence is demonstrated using alternative data.
Micro Therapeutic Research Labs is a contract research organization (CRO) which conducts the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorization 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 CHMP concluded that data from studies conducted at the sties between June 2012 and June 2016 are unreliable and cannot be accepted as a basis for marketing authorization in the EU. However, there is no evidence of harm or lack of effectiveness of medicines authorized 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 will be sent to the European Commission for a legally binding decision valid throughout the EU.
Please refer to the following website in European Medicines Agency for details:
http://www.ema.europa.eu/../news_detail_002719.jsp&mid=WC0b01ac058004d5c1
In Hong Kong, bioavailability and bioequivalence (BABE) studies are the registration requirement of the 29 antiepileptic drugs and the 38 critical dose drugs / narrow therapeutic range drugs (NTRD). Among the products announced by EMA, only ethinyl estradiol and gliclazide are the drugs that require BABE studies as registration requirement in Hong Kong. For the 6 ethinyl estradiol containing products and 3 gliclazide containing products announced by EMA, none of them are registered pharmaceutical products in Hong Kong.
Ends/ Saturday, March 25, 2017
Issued at HKT 12:30
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