The purpose of medicines regulation is to safeguard public health by taking all appropriate measures to ensure that the medicinal products placed on the market are safe, effective and of high quality and that pharmaceutical activities are carried out according to established standards.
The main legislation related to medicinal products is Directive 2001/83/EC as amended. This Directive was transposed in the Maltese legislation as the Medicines Act (Chapter 458 of the Laws of Malta). The Medicines Authority was established by virtue of the Medicines Act (2003).
Effective medicines are capable of treating and curing diseases. However, they can also cause adverse side effects, which, in some instances, can be serious and possibly even dangerous. Legal provisions require that a marketing authorisation is essential for a medicinal product to be placed on the market.
Pharmaceutical companies need to demonstrate that a medicinal product is of the required quality, safety and efficacy and rigorous procedures of evaluation are followed before a medicinal product is granted a marketing authorisation to ensure that products have more benefits than risks.
This evaluation for marketing authorisation entails the need for proof that the medicine has a positive benefit-risk balance, that is, the medicine does more good than possible harm.
After authorisation, medicinal products continue to be monitored to ensure that this positive benefit-risk balance is maintained when the medicine is used in clinical practice. Over the past decade, there have been global efforts to provide effective systems for the monitoring of the safety of medicinal products. Pharmaceutical companies need to submit safety updates on authorised medicines. Adverse drug reactions (ADRs) encountered by patients are reported to regulatory authorities. This information on ADRs is pooled into a European database and is monitored and evaluated. If, during the lifetime of a product there are additional adverse effects to what was expected at the time of marketing authorisation or the benefit-risk balance is considered to be negative, the medicinal product may have its authorisation varied, suspended or even revoked.
The Medicines Authority takes all appropriate measures to ensure that all operators carrying out activities along the supply chain, namely, manufacturers, importers, wholesale dealers and pharmacies are in line with standards of good practice. Inspections are conducted on all operators and sampling and testing of medicinal products is done on packs taken up from different points along the supply chain.