Abridged Applications

The guideline does not include the design of in-use test, nor does it cover abridged applications (in all regions), clinical trial materials, or generic products. In-use considerations can be complicated and need to be addressed in the future. 

Pharmaceutical Subcommittee (PSQ. The PSC reviews the chemical and pharmaceutical issues, including bioavailability and bioequivalence for each application before consideration by the full committee of ADEC. In effect, it is the PSC which makes recommendations on behalf of the ADEC in relation to pharmaceutical aspects of applications being proposed for registration. The PSC also advises ADEC on matters of policy in the pharmaceutical area and acts as arbitrator between the TGA and an applicant who objects to a TGA request for bioequivalence data in certain types of abridged applications. 

Abridged applications— Applying Article 5133 b of CSP for an application for a product equivalent to a preparation in 3i Pharmacopoeia or National Formulary, the applicant may dispense with the expert report on the pharmacology, toxicology and clinical data, if the following are demonstrated ... 

Abridged applications such as line extension (new strengths, dosage forms, etc.) when the part of the documentation submitted earlier should not be repeated. 

New I-NMAs and L-NMA are effectively abridged applications, because they do not need to contain the detailed clinical and toxicological data required for a New H-NMA. 

The MRP can be used for both full-length and abridged applications. Variations to an authorization obtained through the MRP or the decentralized procedure follow the same regulatory pathway. The MRP cannot be used for products that have received a negative opinion or have been withdrawn from the CP (see below), except by submitting a completely new dossier. 

Abridged applications are possible for new applications regarding products that have previously been approved through the CP. 

The EMEA will validate the dossier within 10 working days. The project manager will consult with the Rapporteur or Co-rapporteur for the need for GMP and GCP inspections, necessity for an ad hoc expert group and so on. The applicant provides any additional information, on request, within a specified time limit. If the application is found valid, the applicant is notified in writing and a timetable for the evaluation is set. However, if the dossier is found severely deficient, the applicant will be requested to either collect it or indicate whether it should be destroyed by the EMEA. In the latter case, the EMEA will retain part of the fee (less for an abridged application) as an administrative charge, but otherwise return the application fee. 

Abridged application 100,000 basic fee (1 strength associated with 1 pharmaceutical form) + 20,000 for each additional strength and/or pharmaceutical form + 5,000 for each additional presentation of a strength and form... 

Full Application Euro 200 000 basic fees Abridged Application Euro 100 000 basic fee Renewal Euro 10 000... 

This guideline does not currently seek to cover the information required for abbreviated or abridged applications, variations, clinical trial applications, etc. 

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