Infarmed announced today that it will maintain the marketing of eight generic medicines from a list of 112 that the European Commission indicated should be suspended in Portugal, following an inspection of the company Synapse, in India.

A decision by the European Commission (EC) is at issue after a "Good Clinical Practices (GCP) inspection of the company Synapse Labs Pvt. Ltd", which guaranteed that there were "regulatory non-conformities". 

In a statement, the National Authority of Medicines and Health Products (Infarmed) stated that, in compliance with the decision of the European Commission (EC), it "will determine the suspension of medicines that are not critical to the national market and for which there are alternatives" for citizens.

However, "medicines will be maintained on the market according to their therapeutic relevance and medical need and if bioequivalence has already been proven" with other drugs, the national authority also assured.

An assessment by the European Medicines Agency (EMA) of various generic medicines is at issue, following a request by the Spanish regulator, which concluded that there was no data or that it was insufficient to "demonstrate bioequivalence", which occurs when two medicines release the same active substance in the body at the same rate and to the same extent under similar conditions.

According to Infarmed, the decision by the EU executive, taken after the EMA's recommendation, included 112 medicines in Portugal, but not all of them are on the market.

Of these 112, seven should maintain the marketing authorisation, as provided for in the European Commission's decision and, of the remaining, 43 are on the market, with two having their situation regularised in the meantime, according to the information released by Infarmed.

"Considering the critical nature and in order to guarantee the normal supply of medicines in our country, of the total of 41 medicines in question, eight medicines will continue to be marketed in Portugal, corresponding to four active substances", Infarmed also stated, adding that this list will be published on its website.

The national regulator also stressed that the risk analysis did not reveal any lack of quality, safety or efficacy of these medicines, which is why users who are taking these drugs should continue their treatments.

Infarmed explained that, following a good clinical practices inspection of the company Synapse, "regulatory non-conformities" were identified.

"The company's quality management system was compromised and, in this sense, doubts were raised about the validity and reliability of the data from the bioequivalence studies carried out by this company", the statement says.

The European Commission's decision provides that each Member State should, for each medicine, assess the potential unmet medical need, considering the low availability of alternative medicines.

Brussels stressed that the EMA "established that the tests carried out by Synapse Labs on these generic medicines did not meet the EU's strict requirements to demonstrate that they are equivalent to the reference medicines".

Read Also: Portugal has to suspend the sale of 111 generic medicines (Portuguese version)