Approval of new medicines

When clinical trials have been completed, the pharmaceutical company applies for marketing authorisation.

The European system of approval offers a choice of several procedures if the producing company wishes the drug to be approved in more than one member state.

Centralised approval

The company can seek centralised approval for the whole EU marketplace. In this case, the administrative aspects are handled by the European Medicines Agency (EMEA) while the scientific investigation is carried out by the Swedish Medical Products Agency in a reporting and a co-reporting country, each of which conducts an independent evaluation.

The reports are then sent to other member states and a decision is made by the European Commission after a scientific committee of the EMEA has expressed its opinion. There are four scientific committees within the EMEA;

  • CHMP - Committee for Medicinal Products for Human Use
  • CVMP - Committee for Medicinal Products for Veterinary Use
  • HMPC - Herbal Medicinal Products Committee
  • COMP - Committee for Orphan Medicinal Products.

Each committee is staffed by experts from the different member states’ regulatory authorities.

Mutual recognition

A company can also choose a route based on mutual recognition. In this case, approval is initially sought in a member state, the so-called reference country, that carries out the original evaluation. This authorisation then forms the basis for applications in other member states, which thus do not need to repeat the evaluation but instead ‘mutually’ accept the investigation of the reference country.

Scientific evaluation

When the Swedish Medical Products Agency is responsible for the scientific evaluation under either of the above procedures, we require answers to a number of questions, for example:

  • How does the new medicine work?
  • Is the medicine effective for the patients for whom it is intended?
  • Are the side effects acceptable in relation to the benefits?
  • Is it manufactured to a high level of quality? 

The judgements made by the Swedish Medical Products Agency must be extremely thorough if the requirements for the quality, efficacy and safety of the medicine are to be maintained.

Nevertheless, we must also work quickly and efficiently so that new and better medicines can be introduced into health and medical care without undue delay. Not until our investigation has given a satisfactory answer are we prepared to make a recommendation in the mutual process, or recommend approval to the EU’s scientific committee. Only then can the medicine be sold and prescribed for patients.

Approval from the Swedish Medical Products Agency or the EU is also needed when medicines already on the market are considered for use against new illnesses, in altered doses, or sale without a prescription.

 

 
 
 

Swedish Medical Products Agency, P.O. Box 26, SE-751 03 Uppsala, SWEDEN | +46 18 17 46 00 | registrator@lakemedelsverket.se | Contact information