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Pharma industry
1 August 2024

MA – Market Authorization of Medicines in Pharmaceuticals: a complete guide

Market Authorization (MA) is a major step in the commercialization of medicines. This authorization ensures the safety, efficacy, and quality of medicines made available to consumers.

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Medicines that have obtained their MA worldwide.
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Market Authorization (MA) is a major step in the commercialization of medicines. This authorization ensures the safety, efficacy, and quality of medicines made available to consumers.

In this article, you will find detailed information on the regulations, criteria for MA, and the steps involved in the MA procedure.

1. What is MA ?

MA is an official authorization granted to any pharmaceutical company by the regulatory authorities of the country, allowing the commercialization of a medicine.

Pharmaceutical MA ensures that the medicine meets the necessary safety, efficacy, and quality criteria to protect patients. It requires a strict and precise market authorization procedure, consisting of successive steps that determine the time it takes to bring a medicine to market.

Based on the assessment of the benefit/risk ratio, MA plays an essential role in public health by ensuring that medicines are reliable and comply with pharmaceutical regulations.

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    2. Regulations and criteria for MA

    a. Regulatory bodies for issuing pharmaceutical MAs

    The main regulatory bodies that issue marketing authorizations for drugs are:

    • The ANSM: National Agency for the Safety of Medicines and Health Products, in France.
    • The EMA: European Medicines Agency, in Europe.
    • The FDA: Food and Drug Administration, in the United States.
    Medicines that have obtained their MA.

    b. The main criteria for obtaining marketing authorization

    The Marketing Authorization of a medication is granted based on the evaluation of the benefit/risk balance of the concerned medication. This balance relies on the consideration of various criteria, including:

    • Safety: the product must be safe for patients.
    • Efficacy: the product must demonstrate its efficacy for the claimed indications.
    • Quality: the product must be of high quality and manufactured in accordance with pharmaceutical regulations and Good Manufacturing Practices (GMP).

    The manufacture of the primary pharmaceutical packaging must meet the requirements of the MA. To find out more about primary pharmaceutical packaging, explore our complete guide.

    Pharmaceutical primary packaging for MA.

    c. Specific regulatory standards and requirements

    The standards and requirements for obtaining Marketing Authorization (MA) can vary by country, but they generally include rigorous clinical trials, strict quality controls, and detailed documentation with the compilation of a Marketing Authorization Application (MAA) dossier.

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      3. The procedure for obtaining Marketing Authorization (MA)

      a. The pharmaceutical MA file

      To obtain Marketing Authorization (MA), the pharmaceutical company must compile and submit a Marketing Authorization Application (MAA) dossier to the relevant authorities containing:

      • An efficacy section: including all the results from clinical studies conducted on humans, demonstrating the efficacy and exact conditions of the drug’s use.
      • A quality section: detailing quality data of raw materials, manufacturing processes, and quality controls.
      • A safety section: with information on the product, its composition, therapeutic indications, pharmacology, toxicology, pharmacokinetics data, and side effects.

      b. The stages in the marketing authorization procedure

      Drugs intended to be marketed in the member countries of the European Union are subject to a “centralized” marketing authorization (MA) procedure with the EMA. The centralized MA is the most commonly used procedure compared to the more limited application of national MA procedures.

      1. The submission of the MA dossier: the pharmaceutical company that wishes to market a drug submits the MA dossier to the regulatory authorities. This dossier contains all information on the drug’s efficacy, quality, and safety.
      2. The evaluation of the MA dossier: the regulatory authorities evaluate the dossier to verify that the product meets all safety, efficacy, and quality criteria.
      3. The approval of the MA dossier: if the product meets all the requirements, the MA is granted, authorizing the commercialization of the product.

      c. Temporary Authorization for Use (ATU)

      The Temporary Authorization for Use is an exceptional measure applied in certain circumstances. It is a French compassionate program allowing the use of drugs before their marketing authorization (MA).

      It allows the availability of drugs before their commercialization, to meet a public health need for a limited period.

      The drug is exclusively provided to patients with serious or rare diseases who have no other treatment options available, by specialist doctors in a hospital setting.

      4. The Marketing Authorization (MA) at the heart of the production of double-tipped ampoules by SFAM

      At SFAM, our double-tipped glass oral ampoules are designed to comply with pharmaceutical regulations, and ensure all quality and safety standards required during the marketing authorization applications for medications.

      Our double-tipped ampoules are manufactured according to high-quality standards, including ISO 9001 and ISO 15378 standards.

      Last but not least, during their production, rigorous quality controls ensure their safety and compliance.

      Opt for our double-tip crushable ampoules and elevate your projects. Check out our brochure or request a quote here!

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