Infarmed supports the sale of eight drugs from a list of 112 with indications for suspension

Infarmed announced on Friday that it will continue to sell eight generics from a list of 112 that the European Commission says should be suspended in Portugal following a review of India’s Synapse.

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

However, “medicines will remain on the market in accordance with their therapeutic significance and medical necessity, and if bioequivalence has already been proven” with other drugs, the national body also assured.

It concerns the European Medicines Agency’s (EMA) assessment of several generic drugs at the request of the Spanish regulator, which concluded that there was no or insufficient data to “demonstrate bioequivalence,” which happens when two drugs release the same active substance. in the body at the same rate and to the same extent under similar conditions.

According to Infarmed, the community leader’s decision, following the EMA’s recommendation, included 112 drugs in Portugal, but not all of them are on the market.

According to information published by Infarmed, of these 112, seven must have a marketing license, as provided for by the decision of the European Commission, and of the remaining 43 are in commercial use, with the situation of two being resolved.

“Given the criticality and to guarantee the normal supply of medicines in our country, of the total 41 medicines in question, eight medicines will continue to be marketed in Portugal, corresponding to four active substances,” Infarmed also said, adding that this list will be published on your website.

The national regulator also stressed that the risk analysis did not reveal any deficiency in the quality, safety or effectiveness of these medicines, therefore users taking these medicines should continue treatment.

Infarmed explained that following a review of good clinical practice at Synapse, “non-compliance with regulatory requirements” was identified.

“The company’s quality management system was compromised, and as such, doubts were raised about the reliability and validity of the bioequivalence studies conducted at this company,” the statement said.

The European Commission’s decision stipulates that each EU Member State must carry out a potential unmet medical need assessment for each medicine, given the low availability of alternative medicines.

Brussels confirmed that the EMA “has determined that Synapse Labs’ tests of these generic medicines do not meet the EU’s stringent requirements for demonstrating their equivalence with reference medicines.”