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Coreper: Start of a review of Synchron Research Services in India

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Coreper: Start of a review of Synchron Research Services in India

The EMA has begun a review of drugs studied by Synchron Research Services, a contracted research organization (CRO) based in Ahmedabad, India.

This follows a Good Clinical Practice (GCP) review and data analysis studies conducted by the Food and Drug Administration of the United States (FDA), which in September 2021 led the FDA to reject all studies conducted under this CRO . Combined with the irregularities identified during previous EU inspections at this CRO, these findings have raised serious concerns about the validity of the study data produced by Synchron Research Services.

Following these findings, the national pharmacovigilance authorities of several countries (Belgium, Denmark, Finland, the Netherlands and Sweden) asked the Coreper Committee for Medicinal Products for Human Use (CHMP) to assess their impact on the benefits and risks of licensed medicinal products based on studies conducted at Synchron Research Services. The EMA was also asked to consider the impact on the medicines currently being evaluated for authorization using data from studies produced by the CRO.

The EMA will now evaluate the available data to determine if any action is needed to protect public health.

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The review covers drugs that are currently licensed or evaluated through national or mutual recognition procedures based on studies conducted by Synchron Research Services, India, on behalf of marketing authorization holders.

More on the process

The review was initiated at the request of the pharmacovigilance authorities of Belgium, Denmark, Finland, the Netherlands and Sweden under Article 31 of Directive 2001/83 / EC.

The review is carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for medicinal products for human use, which will give an opinion to the Agency. The CHMP opinion will then be forwarded to the European Commission, which will issue a final legally binding decision valid in all EU Member States.

Source: politis.com.cy

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