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Home / Patient / Consumer / Know more about Medicines Regulation / How medicines are registered

How medicines are registered

 

Introduction

All medicines must be approved by a regulatory body before being placed on the market. In Malta, the Medicines Authority assesses the information submitted for registration of medicines and the Licensing Authority issues the marketing authorisations. There are different procedures by which medicines can be granted a Marketing Authorisation or licence, namely the National, Mutual Recognition/Decentralised and Centralised Procedure. 

The registration process

An applicant who intends to place a new medicine on the market must provide sufficient evidence that the medicine actually works, is of good quality and is acceptably safe for the patient. Extensive research, tests and analysis are carried out for the development of a new medicine. Once developed, the medicine is tested and clinical trials are also performed on a number of patients following strict safety criteria. Patients on the trial are followed up closely in order to follow their progress and to identify any side effects related to the medicine. 

The applicant is then requested to:

  • Compile a dossier containing all the relevant information about the product in accordance with rigorous regulatory guidelines and regulations, including detailed description of all tests and trials carried out and results obtained.
  • Prepare a document summarising all the information that the doctor and healthcare professional need to know about the medicine before prescribing, dispensing and administering it to the patient. This document is known as the 'Summary of Products Characteristics' (SmPC).
  • Prepare the artwork of the packaging to be used when placing the product on the market (box/bottle in which the medicine is marketed).
  • Prepare the patient leaflet which must contain all the information that the patient needs to know before and while he/she is taking the medicine. 

 

All this information is submitted to the Medicines Authority for assessment. The Medicines Authority assesses all the data and the Licensing Authority issues a Marketing Authorisation only after ensuring that all regulatory requirements are met and that the product is of good quality, it actually works and is acceptably safe for the patient.

Benefit-Risk Assessment

All medicines have side effects and side effects might not appear in everyone. Some are very common, whilst others are rare. Some are minor and reversible but others might be more serious. These side effects are weighed by the Medicines Authority when assessing the dossier of the medicine and the medicines are only granted an authorisation if the benefits outweigh the risks for the patient. The Medicines Authority inspects the manufacturing site/s, where the medicine has been manufactured, if it has not already been inspected by another Health Authority in the European Union. Distribution and local pharmacies are also inspected. This is to ensure that there is implementation of good standards across the supply chain. 

Once a Marketing Authorisation is issued and the medicine is placed on the market, the Medicines Authority will continue to regulate the medicine to ensure patients' safety. Healthcare professionals and patients are encouraged to report to the Authority, any unexpected side effects or problems related to the medicinal product. Industry is also obliged to report any defects encountered post-approval. The Medicines Authority investigates such reports and issues warnings or could possibly request a recall or withdrawal of medicines as required in order to protect the patients. The Medicines Authority makes sure that healthcare professionals and patients are informed about any new information concerning individual medicines which might become available through different media including circulars on the safety and the quality of medicines and SMS and e-mail notifications.