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Bioequivalence studies performed at the site cannot be used to support medicines approval in the EU. On 21 Julythe 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 semler research center in bangalore dating using alternative data.
Bioequivalence studies usually form the basis for approval of generic medicines. The list of medicines recommended for suspension is available. The findings from FDA and WHO inspections called into question the quality management system in place at Semler, and semler research center in bangalore dating the reliability of the data of all bioequivalence studies, including those used to support 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 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.
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. Clinical and Bioanalytical Studies Conducted by Semler Research Are Unacceptable. It also included ongoing marketing authorisation applications for medicines which use study data from these sites.
No generic medicine authorised centrally via EMA was tested in these sites. Semler is a contract research organisation CRO with an analytical and a clinical site located in Bangalore, India. These sites conduct the analytical and clinical parts of bioequivalence studies, some of which are used to support marketing authorisation applications of medicines in the EU. The Semler site also performs bioequivalence studies for some medicines authorised in the US and medicines included in the WHO prequalification programme.
The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 22 September 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. Semler Email Help iBeginShare. Information for patients and healthcare professionals A number of medicines for use in the EU rely on studies carried out at the Semler site in India.
The bioequivalence studies performed at the Semler site have been found to be flawed, so they cannot be relied on. As a result, several medicines approved in the EU have been suspended. The list of medicines recommended for suspension. National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available, while new data are generated.
There is currently no evidence of unexpected harm or lack of effectiveness with any medicine approved on the basis of studies conducted at Semler. This is because during this review, alternative studies from different sources were provided that show bioequivalence. Medicines still under evaluation cannot be granted authorisation in the EU on the basis of studies conducted at Semler; further data would have to be provided to support authorisation. Medicines that have been suspended can have their suspension lifted if the companies provide alternative data demonstrating bioequivalence.
Patients should continue to take their medicines as prescribed and contact their doctors in case of questions or concerns. More about Semler Semler is a contract research organisation CRO with an analytical semler research center in bangalore dating a clinical semler research center in bangalore dating located in Bangalore, India.
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