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In April, the European Medicines Agency (EMA) published a new document on regulatory procedural advice on similar biological medicines. This paper is supposed to complement existing guidelines by a collection of questions and answers about regulatory and procedural requirements. It should be read in conjunction with the Agency's scientific guidelines on biosimilars. The guidance information of this new document together with the related published information in the sections "Pre-Authorisation" and "Regulatory" on the Agency's website , should enable Applicants to submit applications which are in conformity with the legal and regulatory requirements. Especially together with the results of pre-submission meetings of authority and applicants. This implicates a more speedily validation. The document includes basic questions like "What is a similar biological medicinal product?" as well as more complex questions like "If the patent situation differs in the various Member States how will this be reflected in the product information of my similar biological medicinal product?" Furthermore, the answers comprise direct links to the related regulations and guidelines. The Agency pointed out, that this document has been produced for procedural advice only and should be read in conjunction with "The rules governing medicinal products in the European Union, Volume 2A, Notice to Applicants". Please see the complete document "EMA Procedural advice for users of the centralised procedure for similar biological medicinal products applications" for further information. Please pay attention to the ECA 8th Bio Production Forum from 19-21 June 2012. Among the main topics of the conference 2012 are the regulatory and scientific requirements with regard to Biosimilars. Author
Axel H. Schroeder
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)
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19-20 June 2013 