PRESS RELEASE BY THE MALTA MEDICINES AUTHORITY AND THE SUPERINTENDENCE OF PUBLIC HEALTH

Following reports of references made, earlier today, by the Honourable leader of the Opposition, Dr Alex Borg, about Generic Medicines, the Malta Medicines Authority, in collaboration with the Superintendence of Public Healt,h is issuing this statement to allay any alarm caused to the many thousands of users of generic medicines. This statement upholds and reaffirms the remarks delivered by the Minister for Health and Active Ageing, Jo Etienne Abela, in Parliament on Tuesday, 30th September 2025.

The Authority is making reference to statements issued by the European Medicines Agency (EMA) with respect to Generic Medicines: “A generic medicine is a medicine that is developed to be the same as a medicine that has already been authorised. A generic medicine contains the same active substances as the reference medicine and is used at the same dose to treat the same disease as the reference medicine.  The name of the medicine, its appearance, such as colour and shape, can be different from those of the reference medicine.  The active substance of a medicine is what gives it its therapeutic effect. Generic medicines are manufactured according to the same quality standards as all other medicines. Regulatory authorities perform periodic inspections of the manufacturing sites to ensure that Good Manufacturing Practices are in place for all medicines. Generic medicines must obtain a marketing authorisation before they can be marketed. Marketing authorisations are granted after a regulatory authority has conducted a scientific evaluation of a medicine’s efficacy (how it works as measured in clinical studies), safety and quality.”

A generic medicine must be shown to be bioequivalent to the brand-named drug.  This means the generic medicine delivers the same amount of active ingredient into the blood over the same period of time, ensuring that a generic medicine works in the body in the same way as the originator. Generic medicines manufactured in Malta and those available to our patients follow the same EU regulations for quality, safety and efficacy as in all other European Union countries. The World Health Organisation (WHO) supports the use of generic medicines as they are safe, good quality and efficacious and have the potential to increase access to essential medicines.

It is important that the general public is not alarmed by any statements which may wrongly infer any inferiority in the quality of generic medicines, both those supplied by the Pharmacy-of-Your-Choice scheme and in the private market.