Let’s try to simplify it.
For mutual recognition (MRP) and decentralised (DCP) procedures, the competent national authorities of the reference state (Reference Member State, RMS) and interested party (Concerned Member State, CMS) are responsible for issuing and maintaining the AIC, supported by the Cmdh (Co-ordination group for Mutual recognition and Decentralised procedures – human), a group created to coordinate the authorisation and pharmacovigilance activities of medicinal products for human use within these procedures. In Italy, the competent national authority for the regulatory activity of medicines managed under the national procedure is a public body called AIFA.
In Italy the electronic Common Technical Document has become mandatory for all medicines registered through the national procedure from 2019.
The files shall be separated by chapter and submitted by the applicant to the competent authority as a whole, referred to as “sequence”.A sequence may consist of all the files that make up the paper document (form 1 to form 5) or simply parts of it, depending on the type of request that is made to the authority (e.g. registration or variation). The sequences are numbered progressively starting from sequence 0000, which contains the complete dossier or its baseline. An eCTD can contain more than one sequence and is able to cover several production sites, different pharmaceutical forms or dosages of the same product and include all requests for renewals, variations, PSUR, ASMF made during the life cycle of the product.
What are the advantages of this system?
The main advantages are two: it facilitates the exchange and storage of data and ensures that the content of the dossier remains unchanged from its preparation until its receipt by the authority.
To facilitate the exchange of data, the program prepares the sequence according to the XML language (Extensible Markup Language). For a person who is totally foreign to the computer world, suffice it to say that it is a language used for the exchange of structured data. To ensure data security instead, the program inserts an “MD5 checksum” in the sequence to be transmitted. Always for “the less experienced”: a “MD5 checksum” is a sequence that uniquely identifies a file (a kind of fingerprint) and serves to check that a data exchange took place without loss of information and without undergoing changes.
JSB Solutions can support the customer in the formatting of the dossier from paper to electronic format, in the creation of the dossier in electronic format and in the management of the entire life cycle of the dossier.