EMA investigation could affect up to 225 UK generic products
A European Medicines Agency (EMA) review is underway of medicines for which clinical studies have been conducted by Synapse Labs Pvt Ltd, a contract research organisation located in Kharadi, India.
The review a follows an inspection carried out by the Spanish Agency of Medicines and Medical Devices “that cast serious doubts on the reliability of the analytical and clinical data generated by Synapse”.
Marketing authorisations for over 225 generic products from 39 UK suppliers are included in the EMA review, which could add to further pressure on medicines supplies in the UK.
The review, which started in July this year, covers generic medicines authorised or currently being evaluated via national, decentralised or mutual recognition procedures on the basis of studies conducted by Synapse Labs. The EU’s Committee for Medicinal Products for Human Use (CHMP) is due to publish its opinion in December.
In the meantime marketing authorisation holders and applicants are being asked provide evidence of bioequivalence of their products with EU reference medicinal products in order to demonstrate “a positive benefit-risk balance”.
The British Generic Manufacturers Association has warned this week that a record number of products are facing supply issues, saying 111 products are now facing supply issues - the highest number on record and more than double since the start of 2022.
Commenting on the report in the Independent newspaper over the weekend, PSNC chief executive Janet Morrison said: ““Medicine shortages and market instability appear to be as bad as they have ever been and are making life incredibly difficult for community pharmacies and their patients.
“The Government and NHS must step in and do more to help protect community pharmacies and their patients from these ongoing supply chain shocks and issues. We would like to see them strategically reviewing medicines supply and giving more powers to pharmacists to help them to better manage their patients’ medicines when shortages do occur.”