Other safety alerts
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| European Union: Synapse Labs Pvt. Ltd: EMA recommends suspension of medicines over flawed studies |
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European Medicines Agency (EMA) announces that its human medicines committee, Committee for Medicinal Products for Human Use (CHMP) has recommended the suspension of the marketing authorisations of a number of generic medicines tested by Synapse Labs Pvt. Ltd, a contract research organisation (CRO) located in Pune, India.
The recommendation follows 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 appropriately manage study data. This raised serious concerns about the validity and reliability of 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.
To reach its conclusion for the over 400 medicines tested by Synapse Labs on behalf of European Union (EU) companies, the CHMP looked at all available information, including bioequivalence data potentially available from other sources. For details of the affected products, please refer to the website in EMA.
For around 35 of the medicines concerned, sufficient supporting data were available to demonstrate bioequivalence; this means that marketing authorisations for these medicines will be maintained and ongoing marketing applications can continue.
For all other medicines, supporting data were lacking or insufficient to show bioequivalence and the CHMP therefore recommended suspending their marketing authorisations. 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.
Some of the medicines that have been recommended for suspension may be of critical importance (e.g., due to 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 2 years in the interest of patients. Companies have to submit the required bioequivalence data for these medicines within 1 year.
EMA and national authorities will continue to work closely together to ensure that studies on EU medicines are carried out to the highest standards and that companies comply with all aspects of good clinical practice. If companies do not meet required standards, authorities will take necessary measures to ensure the integrity of data used to approve EU medicines.
The CHMP's recommendation will now be sent to the European Commission which will issue a 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 tested them is considered unreliable.
- There is no evidence of harm or lack of effectiveness with any of the affected medicines. However, the medicines have been suspended until supporting data from more reliable sources are available.
- Patients taking the affected medicines can contact their doctor or pharmacist for information about alternatives.
- National authorities in the EU will consider how critical individual medicines are in their countries and make final decisions on whether to suspend or allow them to remain available while new data are generated.
Please refer to the following website in EMA for details:
http://www.ema.europa.eu/en/news/synapse-labs-pvt-ltd-ema-recommends-suspension-medicines-over-flawed-studies
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 is no registered pharmaceutical product containing Primidone and Zonisamide. 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. The Department of Health will remain vigilant on safety update on this matter issued by other overseas drug regulatory authorities. Related news was previously issued by EMA, and was posted on Drug Office website on 22 Jul 2023.
Ends/ Monday, December 18, 2023
Issued at HKT 16:15
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