Other safety alerts
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| European Union: Synapse Labs Pvt. Ltd: Re-examination confirms suspension of medicines over flawed studies |
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European Medicines Agency (EMA) announces that its human medicines committee, the Committee for Medicinal Products for Human Use (CHMP) confirmed its recommendation to suspend or not grant the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India on 21 Mar 2024. This confirmation concludes the re‑examination requested by the applicants and marketing authorisation holders for some of the medicines concerned.
The CHMP adopted its initial recommendation in Dec 2023, after a good clinical practice (GCP) inspection which showed irregularities in study data and inadequacies in study documentation and in the computer systems and procedures to manage study data. This raised serious concerns about the data from bioequivalence studies conducted at the CRO. Such studies are carried out to show that a generic medicine releases the same amount of active substance in the body as the reference medicine.
For the majority of the medicines tested by Synapse Labs on behalf of European Union (EU) companies, the CHMP concluded that supporting data were lacking or insufficient to show bioequivalence and therefore recommended suspending the marketing authorisations of these medicines. For a small number of the medicines, sufficient supporting data were available to demonstrate bioequivalence; marketing authorisations for these medicines were maintained and ongoing marketing authorisation applications could continue.
As a result of the CHMP’s initial opinion and re-examination, the recommendation to suspend medicines for which adequate bioequivalence data are lacking is confirmed. To lift the suspension, companies must provide alternative data demonstrating bioequivalence. Medicines for which ongoing marketing authorisation applications rely solely on data from Synapse Labs will not be granted authorisation in the EU. An updated list of the medicines affected by the procedure is available on EMA’s website.
Some of the medicines that have been recommended for suspension may be of critical importance (e.g., due to a lack of available alternatives) in some EU Member States. National authorities will assess the situation and can postpone the suspension of these medicines for a maximum of two years in the interest of patients. Companies have to submit the required bioequivalence data for these medicines within one year.
The CHMP's recommendation will now be sent to the European Commission which will issue a legally binding decision in due course.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-18-21-march-2024
Among the 103 drug ingredients/combinations of drug ingredients recommended for suspension by EMA, submission of bioequivalence data is required for 11 drug ingredients (namely, carbamazepine, gabapentin, lacosamide, oxcarbazepine, phenytoin, primidone, topiramate, zonisamide, clindamycin, digoxin and methotrexate) for registration of pharmaceutical product in Hong Kong.
Currently, there are registered pharmaceutical products containing carbamazepine (6 products), gabapentin (26 products), lacosamide (6 products), oxcarbazepine (6 products), phenytoin (5 products), topiramate (26 products), clindamycin (81 products), digoxin (4 products) and methotrexate (10 products). These products are not manufactured by the companies marketing the related products as listed by EMA. In addition, the bioequivalence study of these products submitted for registration were not conducted by Synapse Labs Pvt. Ltd. There is currently no registered pharmaceutical product containing primidone and zonisamide.
Related news was previously issued by EMA, and was posted on Drug Office website on 22 Jul 2023 and 18 Dec 2023. The Department of Health will remain vigilant on safety update on this matter issued by other overseas drug regulatory authorities.
Ends/Monday, Mar 25, 2024
Issued at HKT 16:30
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