Registration application

Stability Data Package for Registration Applications in Climatic Zones III and IV Analytical Validation... 

As shown in Table 8.1, all the countries have written registration application forms, as well as written criteria for dmg assessment and registration. It is unclear, however, whether written documents detailing the registration procedures are available for the applicants, in addition to the application forms. 

This article defines the criteria and processes for computer validation. Computer validation applies to all systems, including electronic capture systems in both the laboratory (scientific instrumentation) and field settings. Any system producing electronic records and documents, which regulators in the evaluation of product registration applications will use, needs to be validated. 

Performance and Regulatory Requirements describes various ways of characterizing the dry powder aerosols and provides information on product quality performance requirements and how these attributes must be reflected in registration applications. 

In June 2004 the Australian Regulatory Guidelines for Prescription Medicines (ARGPM) were issued by the TGA to replace the AGRDl. Under the ARGPM the format for registration applications in Australia is the Common Technical Document (CTD) developed through the International Conference on Harmonisation (ICH). 

U.S. Food and Drug Administration (FDA) (2004), Guidance for industry, ICH Q1F, Stability data package for registration applications in climatic zones III and IV, FDA, Rockville, MD. 

The long-term testing should cover a minimum of 12 months duration on at least three primary batches at the time of submission and should be continued for a period of time sufficient to cover the proposed shelf life. Additional data accumulated during the assessment period of the registration application should be submitted to the... 

Commitment Batches — Production batches of a drug substance or drug product for which the stability studies are initiated or completed postapproval through a commitment made in the registration application. 

Ultimately the technical objective of an analytical procedure, which is included as part of a registration application for pharmaceuticals, is the responsibility of the analytical department. This objective is directly related to the regulatory objective as defined by the regulatory professionals. For example, the regulatory professionals require a means to quantitate an API in a finished pharmaceutical for release between 95-105% of label claim. This translates into a technical objective for the analytical chemist that involves the selection of an analytical technique and the development of a method that has the required accuracy and precision to meet the requirements for release. 

Registration applications should include 6 months accelerated data, 6 months intermediate storage conditions data if applicable, and 12 months, long-term data. 

By the time preparation of a registration application has begun, voluminous amounts of stability information and data are available. What should be included in the registration application and what is the best way to present the information and data ... 

The International Conference on Harmonization (ICH) has developed guidelines for stability testing of new drug substances and products [12-14], The guideline outlines the core stability data package required for Registration Applications. 

General concern for internationally recognized priority chemicals specialized national issues based on identifying die significance of international priority substances (e.g., dioxins) local issues relating to either toxic incidents or new chemical registration applications... 

To complete a registration, applicants must submit a voluminous dossier with technical data, ranging from the name of the substance to its physico-chemical properties and a base set of toxicity and eco-toxicity test results. While notifiers of new substances under the Sixth Amendment to Directive 67/548/EEC submitted this dossier to NRAs, new and existing substance producers and importers alike are now expected to report directly to ECHA. This shift deprives Member States of an early opportunity to communicate with the registrant and, where indicated, stage an early formal or informal intervention.22... 

The use of existing manufacturing facilities also overcomes another common limiting factor in product development the availability of product for test purposes and clinical trials. All critical tests must be done with a product which is essentially the same as the final product, if the data from these tests are to be used for the registration application. Research material of dubious quality is definitely not appropriate. 

A registration application is initially examined for completeness and compliance with the formal requirements, before the technical and scientific examination by specialized groups commences. The first official response from an authority may be a notification of the deficiencies of the dossier. Partly the objections may address only formal faults, other problems may be clarified by reference to the existing data, in other cases additional studies may have to be conducted to provide the required information. 

Test vaccines made according to the production method for which the registration application is submitted... 

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