The EMA has launched a review of drugs for which studies have been conducted by Synchron Research Services, a contract research organisation (CRO) based in Ahmedabad, India.
This follows a Good Clinical Practice (GCP) review and study data analyses conducted by the United States Food and Drug Administration (FDA), which in September 2021 led the FDA to reject all studies conducted at this CRO. Combined with irregularities identified during previous EU inspections of this CRO, these findings have raised serious concerns about the validity of study data generated by Synchron Research Services.
After taking these findings into account, the national pharmacoregulatory authorities of several countries (Belgium, Denmark, Finland, Finland, the Netherlands and Sweden) requested the EMA Committee for Medicinal Products for Human Use (CHMP) to assess their impact on the benefits and risks of medicinal products licensed on the basis of studies conducted at Synchron Research Services' facilities. EMA was also asked to consider the impact on medicines currently being evaluated for licensure that use study data generated by this CRO.
EMA will now evaluate the available data to determine if any action is required to protect public health.
More about the medicines
The review covers medicines currently licensed or evaluated through national or mutual recognition procedures on the basis of studies conducted by Synchron Research Services, India, on behalf of marketing authorisation holders.
More about the process
The review was initiated at the request of the pharmacoregulatory authorities of Belgium, Denmark, Finland, the Netherlands and Sweden under Article 31 of Directive 2001/83/EC.
The review is conducted by the Committee for Medicinal Products for Human Use (CHMP), responsible for matters relating to medicinal products for human use, which will provide an opinion for the Agency. The opinion of the CHMP will then be forwarded to the European Commission, which will adopt a final legally binding decision valid in all EU Member States.
(AF)
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