The European Medicines Agency’s human medicines committee (CHMP) has advised suspending the marketing authorizations of several generic medicines tested by Synapse Labs, a contract research organization located in Pune, India. This decision comes after a Good Clinical Practice (GCP) inspection revealed irregularities in study data, deficiencies in study documentation, and shortcomings in the computer systems and procedures for managing study data. These findings have raised serious doubts about the accuracy and dependability of data from bioequivalence studies conducted at the CRO. Bioequivalence studies are conducted to demonstrate that a generic medicine releases the same amount of active substance in the body as the reference medicine.

In assessing over 400 medicines tested by Synapse Labs on behalf of EU companies, the CHMP thoroughly reviewed all available information, including potential bioequivalence data from other sources. A list of the affected medicines is accessible on the EMA website.

For approximately 35 of these medicines, sufficient supporting data were present to confirm bioequivalence. Consequently, marketing authorizations for these medicines will remain valid, and ongoing marketing applications can proceed.

However, for all other medicines, the supporting data were either absent or inadequate to establish bioequivalence. Consequently, the CHMP has recommended suspending their marketing authorizations. To lift the suspension, companies must provide alternative data demonstrating bioequivalence. Medicines for which ongoing marketing authorization applications rely solely on data from Synapse Labs will not receive authorization in the EU.

Some of the medicines recommended for suspension may be critical in certain EU Member States where alternatives are limited. National authorities will evaluate the situation and may delay the suspension of these medicines for up to 2 years in the interest of patients. Companies are required to submit the necessary bioequivalence data for these medicines within one year.

EMA and national authorities will maintain close collaboration to ensure that studies on EU medicines adhere to the highest standards, and that companies comply with all aspects of good clinical practice. Should companies fail to meet these standards, authorities will take necessary actions to safeguard the integrity of data used in approving EU medicines.

The CHMP’s recommendation will now undergo review by the European Commission, which will issue a legally binding decision in due course.1

For more information, please follow this link.

References

  1. Synapse Labs Pvt. Ltd: EMA recommends suspension of medicines over flawed studies | European Medicines Agency. (2023, December 15). https://www.ema.europa.eu/en/news/synapse-labs-pvt-ltd-ema-recommends-suspension-medicines-over-flawed-studies

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