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  2. Marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Marketing_authorisation

    This process is performed within a legal framework defining the requirements necessary for successful application to the regulatory authority, details on the assessment procedure (based on quality, efficacy and safety criteria), and also the circumstances where a marketing authorisation already granted may be withdrawn, suspended or revoked. [1]

  3. European Medicines Agency - Wikipedia

    en.wikipedia.org/wiki/European_Medicines_Agency

    The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).

  4. Paediatric-use marketing authorisation - Wikipedia

    en.wikipedia.org/wiki/Paediatric-use_marketing...

    Like ordinary EMA marketing authorisations, a PUMA approval is valid in all countries of the European Economic Area (the European Union as well as Iceland, Liechtenstein, and Norway). The PUMA process was established to make it more profitable for pharmaceutical companies to market drugs for children.

  5. Investigational New Drug - Wikipedia

    en.wikipedia.org/wiki/Investigational_new_drug

    The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.

  6. Biovest Conducts Meeting with EMA Advancing Process to Seek ...

    www.aol.com/news/2012-09-20-biovest-conducts...

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  7. Strimvelis - Wikipedia

    en.wikipedia.org/wiki/Strimvelis

    In April 2016, a committee at the European Medicines Agency (EMA) recommended marketing approval for its use in children with adenosine deaminase deficiency, for whom no matched HSC donor is available, on the basis of a clinical trial that produced a 100% survival rate; the median follow-up time was 7 years after the treatment was administered.

  8. EU regulator backs approval for ARS Pharma's nasal spray ...

    www.aol.com/news/eu-regulator-recommends...

    The FDA will review the nasal spray again and is expected to decide on its approval by Oct. 2. William Blair analyst Tim Lugo said the EU recommendation bodes well for a FDA approval.

  9. International Council for Harmonisation of Technical ...

    en.wikipedia.org/wiki/International_Council_for...

    In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.