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Streamlined submission process for prescription medicines
On 1 November 2010, the TGA introduced a streamlined submission process for prescription medicine applications that require the evaluation of non-clinical, clinical and/or bioequivalence information (category 1 and category 2 submissions).
The streamlined submission process is explained in Transitional prescription medicine streamlined submission process - January 2011. The key elements are outlined below.
|Phases and milestones||The streamlined submission process consists of eight phases with eight milestones, allowing effective planning and tracking by the TGA and sponsors.|
|Pre-submission||During the pre-submission phase, sponsors complete and lodge a pre-submission planning form (PPF). The PPF provides information on the scope and scale of a submission, including details of the quality, non-clinical, and clinical evidence. The information provided in the PPF allows the TGA to effectively assign resources for the evaluation process.|
|Submission quality||Sponsors must lodge well-planned, high quality, complete submission dossiers. Sponsors must ensure submissions meet the TGA requirements for format and content. Where sponsors submit incomplete, delayed, or poor quality submissions, the submission will be considered not effective and therefore not accepted for evaluation.|
The previous 40 working day period for the screening of submissions on receipt has been replaced by a shorter period for ascertaining whether the submission will be considered effective and therefore accepted for evaluation, or not effective and not accepted for evaluation.
For straightforward submissions, this process will generally be completed in a 15 calendar day period. Complex submissions may take longer.
|Consolidated s. 31 request for information||At the completion of the 1st round assessment phase, the TGA will prepare a consolidated s. 31 request for information. This request will be sent at the pre-designated date specified in the planning letter so sponsors can conduct any necessary preparation activities.|
|No additional or supplementary data after submission lodgement||The documentation lodged in the submission dossier will be taken as the complete application.|
The first 12 months under the streamlined submission process constitute the transition period to allow some of the issues raised by sponsors and industry bodies in the consultation process, as well as the significant changes in business process, to be reviewed and modified as necessary in the light of experience.
Regulatory & supporting documents
- Electronic submission dossier requirements
- Transition information about the streamlined submission process
- Common technical document (CTD)
- Section 23 instruments
BPR update newsletter
The Prescription medicine BPR update newsletter (BPR update) reports on progress in the business process reform (BPR) program. The implementation of the streamlined submission process is one project within the BPR program. Each month, the BPR update provides information on the progress of PPFs and submissions under the streamlined submission process and other information to assist sponsors with the new requirements.
Consultations about the streamlined submission process
The TGA has consulted with industry groups and sponsors throughout the development of the streamlined submission process. The TGA continues to consult closely with industry through the Industry Working Group as the streamlined submission process is implemented. The outcomes of the IWG are reported in the BPR update newsletter.
In February 2010, the TGA conducted public information sessions to provide stakeholders with an opportunity to gain a detailed understanding of the proposed streamlined submission process for prescription medicines and discuss any issues or concerns. The sessions were held in Melbourne (17 February), Sydney (24 February), and Brisbane (26 February). More than 300 people attended the information sessions and the TGA received 32 submission in response to the consultation paper.
Sponsor education & training
The TGA conducted a second round of three-hour workshops on the streamlined submission process in Brisbane (1 June), Melbourne (6 June), and Sydney (8 June). Further details are available in the May 2011 edition of the BPR update newsletter.
In October and November 2010, the TGA in partnership with ARCS Australia (formerly the Association of Regulatory and Clinical Scientists), conducted half-day information sessions in Brisbane, Melbourne, and Sydney for industry members. The sessions provided information on the rationale and scope of the new streamlined submission process, and the new process requirements. The sessions also provided industry members an opportunity to ask questions of the TGA project team and TGA evaluators.