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In most countries, a marketing authorisation is valid for a period of 5 years. After this period, one should apply for renewal of the marketing authorisation, usually by providing minimal data proving that quality, efficacy and safety characteristics are maintained and the risk-benefit ratio of the medicinal product is still favourable.
A centralised marketing authorisation, issued by the European Commission, allows the holder to market a medicinal product throughout the European Economic Area (EEA), which comprises the EU Member States, Iceland, Norway and Liechtenstein. [2] In the United States, the equivalent process is called New Drug Application.
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The minimum essential documents that are required for the registration of pharmaceutical products designed for human use are specified in the document 'ICH Good Clinical Practices,' published in 1997 by the ICH [2] Example ICH essential documents that would be required in any US, EU or Japan based clinical trial would include: signed protocol ...
Pfizer's XALKORI ® Receives Conditional Marketing Authorization from the European Commission for the Treatment of Adults with Previously Treated ALK-Positive Advanced Non-Small Cell Lung Cancer ...
Penn State University is playing its first game in the College Football Playoff in just a few days and is facing a shakeup in the quarterback room thanks to the sport’s wide-open transfer rules.
Image credits: midnightsunofab**ch #3. My daughter was born with Cystic Fibrosis. We knew she was going to have this due to genetic testing that was done before she was born.
A Certification Practice Statement (CPS) is a document from a certificate authority or a member of a web of trust which describes their practice for issuing and managing public key certificates. [1] Some elements of a CPS include documenting practices of: issuance; publication; archiving; revocation; renewal