API dossier requirements

The requirements to an API registration dossier are regulated by the Federal Law 61-FZ “On circulation of medicinal drugs”, the contents of  technical parts of the dossier are similar to European Medicines Agency (EMA) EDMF as regulated by EMA Guideline on Active Substance Master File Procedure.

There are national specifics for the administrative part and the ND (see below)

Our API registration inquiry form contains all required dossier parts of an API from your side.

Moreover, the inquiry form also reflects all key parameters of your potential API(s) registration process in detail – those choices are very flexible with Pharegis and they are completely yours, as we never urge using our services like big «as is» package.

However, in case of several registration projects we could gladly propose you an exclusive offer that will fully satisfy your needs and the budget.

We will check your inquiry for API registration and reply with the specific commercial offer shortly. In our commercial offer we will also provide you information on services options that you can choose from.

Understanding of “ND”

The key reference for a registered API

Normative document (ND) of registered API is part of that API registration dossier, and it is the main reference document of the registration dossier for the commercially registered API.

The ND is to be approved and issued by MoH together with the official registration letter (MoH letter for inclusion of the API to the State Register of Medicines of the Russian Federation) to the applicant of the API registration.

Contents and confidential nature of ND

Any ND is written in Russian language and is the reference for corresponding API’s nomenclature, QC specification, detailed description of QC methods, packaging, labelling, storage and transportation conditions, as well as for the shelf life.

 Apart the applicant and the API manufacturer, only MoH, MIT, Roszdravnadzor (being the federal executive bodies); authorized expertise institutions (specifically - FSI SCEEMP and FSI SID &GP) and accredited certification institutions have access to the ND - it is not a document for public use. ND is also used as the reference by customs authorities during API importation procedures.

However, an ND in most cases does not contain sections of Restricted Part of corresponding API dossier and does not reflect any parts of the manufacturing process and parameters details, as well as the validation data.

Potential adjustments to initial API dossier

The main difference between initial API dossier sections and the ND is that the ND should comply to Russian national regulations.

In terms of the QC sections of the dossier, in order to be registered in Russia, API should correspond to requirements of Russian State Pharmacopeia. That applies to both specification limits and additional QC tests. So initial API dossier sections should be checked (and adjusted if needed) before the submission for API registration in order to correspond to the API ND.

Any specification and QC tests in ND can contain references to USP, Eu.Ph., BP or other compendial monographs, as well as in-house validated QC methods. So there is absolutely no need to adjust all QC to monographs of the Russian Pharmacopeia.

Nevertheless, there are cases where methods stated in Russian State Pharmacopeia (RSP) have more strict limits. In that case RSP limits should apply in the API dossier submitted for the registration.

Also, additional QC tests can be required as per RSP for particular formulations. For example, QC tests like “Abnormal toxicity” and “Depressive substances” as well as “Bacterial endotoxins” are frequently requested by MoH to be added to ND as per RSP requirements.

Sterile API, APIs intended for production of sterile formulations, API derived from human or animal blood, organs, tissues, plant materials, microorganisms/produced by microorganisms often have such additional QC tests in the API specifications for export to Russia and the corresponding API NDs.

What we do with ND and API registration dossier

There is no need to know all subtleties about the ND since it is part our daily work we do during gap analysis and API dossiers preparation.

We prepare all NDs from scratch, strictly considering all adjustments with the manufacturer in advance, under strict local regulations (including e.g. used fonts’ sizes) for its format and contents. Considering all dossier adjustments with the manufacturer and preparation of the ND are our routine, yet very important activity we thoroughly perform for each API registration application.

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