EMA's Committee for Medicinal Products for Human Use (CHMP) confirmed its recommendation of 
suspend the marketing authorizations (MAs) of various generic medicines being tested by Synchron Research Services, a Contract Research Organization (CRO) based in Ahmedabad, India. This concludes the request for review presented by the marketing authorization holders of some of the medicines concerned.
The CHMP has adopted the own initial recommendation in May 2022, after irregularities were found in the way the CRO conducted bioequivalence studies, which raised serious concerns about the company's quality management system and the reliability of data from that site. Bioequivalence studies are carried out to show that a generic medicine releases the same amount of active substance into the body as the reference medicine.
The CHMP concluded that adequate bioequivalence data from other sources were not available for most of the medicines and recommended their suspension. However, adequate bioequivalence data from other sources were available for a limited number of authorized generic medicines, allowing them to continue to be marketed in the EU.
During the re-examination, the CHMP noted that adequate bioequivalence data from an alternative study are available for eight medicines. Therefore, the marketing authorization for these medicines can be maintained1.
Following the initial opinion and the CHMP re-examination, the recommendation to suspend around 100 medicines for which adequate bioequivalence data was lacking was confirmed. In order to be able to lift the suspension, companies will have to provide alternative data demonstrating the bioequivalence of their products. The medicines, whose ongoing MA applications are based solely on data from Synchron Research Services, will not be authorized in the EU. On the EMA website, thelist update of the medicines affected by the procedure.
As some of the medicines recommended for suspension may be essential (for example due to a lack of available alternatives) in a given EU Member State, national authorities can temporarily postpone the suspension in the interest of patients. Member States will also have to determine whether a recall of the medicinal products in question is necessary in their territory.
EMA and national authorities will continue to work closely to ensure that studies on EU medicines are conducted to the highest standards and that companies comply with all aspects of the rules of good clinical practice (GCP). If companies do not meet the required standards, the authorities will take all necessary steps to ensure the integrity of the data used to approve medicines in the EU.
The CHMP recommendation will be forwarded to the European Commission, which will adopt a final legally binding decision in due course.
Information for patients and healthcare professionals
- Several generic medicines have been suspended from the EU market because the company that carried out the bioequivalence studies may have provided unreliable data.
- None of the medicines in question proved to be dangerous or ineffective. However, they have been suspended until there is supporting data from more reliable sources.
- Alternative medicines are available. Patients taking the medicines affected by the suspension should contact their doctor or pharmacist for more information.
EU national authorities will examine the importance of individual medicines in their respective countries and make a final decision whether to suspend them or allow them to be marketed until new data become available.
Read more about medicines
The review covered generic medicines authorized or evaluated through the national procedure based on studies conducted by Synchron Research Services, located in Ahmedabad, India, on behalf of the MAHs. The medicines have been authorized or are being evaluated for approval in several EU Member States.
See the specific information of the medicines in question.
Read more about the procedure
The review was initiated in January 2022 at the request of the national regulatory agencies of several EU countries (Belgium, Denmark, Finland, the Netherlands and Sweden) under theArticle 31 of Directive 2001/83/EC.
The review was carried out by the CHMP, responsible for questions relating to medicinal products for human use, which issued its initial opinion on 19 May 2022. Following the request submitted by the marketing authorization holders of some of the medicines concerned, the CHMP reviewed its opinion of May 2022. The final opinion adopted by the CHMP will be forwarded to the European Commission, which will adopt a final decision that is legally binding and enforceable in all EU Member States.
AIFA – Published on: 21 September 2022
1Diuver, Torasemide Teva, Torasemide AL, Torasemid-ratiopharm, Torasemid STADA, Torasemide and Torasemide Teva Italia. These products have been removed from the list of medicines recommended for suspension.
List of nationally authorized medicinal products and marketing authorization applications
