Skip to content
Back to folders

6 things you should know about drug marketing authorizations (MA)

A marketing authorization (MA) for a medicine is the approval to market it that is granted once its benefit-risk ratio has been assessed by the relevant health authorities.

If a pharmaceutical company wishes to market a medicine, it must submit a marketing authorization application to the competent health authorities in the target country or region. The request takes the form of an application file, or ‘dossier’, in which pharmaceutical, preclinical and clinical quality data from the development phases are compiled.

An MA certifies that the risk-benefit ratio is positive for the claimed indication. The health authorities that authorize medicinal products by issuing marketing authorizations (which they may also suspend or withdraw) monitor and supervise them.

Did you know?

A conditional MA may be granted subject to conditions, for a limited period, on the basis of assessment data that is still incomplete. It is granted if the benefit-risk ratio is positive and there are no equivalent medicinal products.

Marketing authorization applications submitted by a pharmaceutical company are assessed by the health authorities of the relevant country or region: the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, the French National Security Agency for Medicines and Health Products (ANSM), and so forth.

The primary mission of these authorities is to assess the quality, the benefits and the risks of medicines, to guarantee that they are safe throughout their life cycle, and to monitor adverse effects.

The requirements for an MA dossier are harmonized (e.g. international guidelines from the International Council for Harmonization – ICH), although some countries may have specific national requirements (e.g. data on ethnic factors, national guidelines on development requirements).

This way, no matter the registration procedure (national, regional), in order to obtain marketing authorization the pharmaceutical company is required to submit a detailed dossier that includes:

  • A quality section: data on the chemical, biological or microbiological quality of the medicinal product, manufacturing processes (production of raw materials, industrial production of the medicinal product, control procedures, etc.);
  • A safety section: pharmacological, toxicological and pharmacokinetic data from preclinical and clinical studies;
  • An efficacy section: all of the results from studies carried out in humans to define the exact conditions of use of the medicinal product and to establish its benefit-risk ratio.
To know

In the case of generic medicines, studies must be submitted regarding bioequivalence1 with the original medicine.

The issuance of an MA is based on an examination of the medicinal product’s benefit-risk balance for the claimed indication and more precisely on the examination of:

  • pharmaceutical quality: composition, stability, sterility, large-scale reproducibility, etc.;
  • safety of use: foreseeable adverse effects associated with its use and their frequency, precautions for use, etc.;
  • demonstration of its pharmacological efficacy with regard to: the intended indications (the disease(s) targeted by the medicine), the profile of the patients for whom it is intended, and the recommended dosage (dose, duration of treatment).

1 to 3 years

If the medicine proves to be effective and safe, it should be assumed that depending on the country, it will take 1 to 3 years between the time that the registration dossier is submitted to the health authorities and when the marketing authorization (MA) is obtained.

Systematic measures govern correct use of the medicine as soon as it is placed on the market. When an MA is granted, the health authorities must specify the specific conditions of use applicable to the medicine:

  • the information contained in the Product Information (PI)for health care professionals or in the patient package insert;
  • its packaging (labeling);
  • the conditions for prescribing and dispensing.
To know

MAs are issued for a limited initial period. Depending on applicable regulations, they may subsequently be renewed indefinitely, unless the health authorities decide to re-evaluate them, notably for reasons relating to pharmacovigilance.

The MA for a drug may be subject to changes, imposed by the health authorities (e.g. addition of a new adverse reaction, precautionary statement) or on the initiative of the pharmaceutical company (e.g. addition of a new adverse reaction, precautionary statement, new indication, new dosage, change in the production process, etc.). These changes, which have an impact on the application on the basis of which the MA was granted, are made after submission of a change dossier, which is assessed by the health authorities.

Lastly, an updated pharmacovigilance report, or Periodic Benefit-Risk Evaluation Report (PBRER), is what makes it possible to monitor the safety of the drug. This report is produced at predetermined dates by the competent health authorities, after the marketing authorization has been granted for the medicine in question.

[1] Bioequivalence between brand-name and generic medicines means that the quantity of active ingredient available (reaching the bloodstream) and the speed at which it reaches the bloodstream are identical (Source: French Ministry of Health and Prevention).