On 27 June 2015, the Committee for Medicinal Products for Human Use (“CHMP”) launched a two month public consultation process on a revised draft Guideline governing the implementation of the accelerated assessment of medicinal products.
The revised draft Guideline provides guidance concerning the expedited assessment of a marketing authorisation application for a candidate medicinal product. It is intended to provide updated procedural advice concerning the submission of a marketing authorisation application that falls within the scope of Article 14(9) of Regulation (EC) No 726/2004. In order to demonstrate that the legal basis for the accelerated procedure is satisfied, an applicant must demonstrate that the candidate medicinal product is “[…] of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation“. Grant of access to the procedure by the CHMP could reduce the timeframe for delivering an opinion on the marketing authorisation application of a candidate medicinal product from 210 days to 150 days.
Arguments for substantiating an accelerated procedure claim
In the absence of a fixed definition of what constitutes a medicinal product of “major interest”, requests for the accelerated handling of a marketing authorisation will be assessed on a case-by-case basis by the CHMP. The draft revised Guideline identifies a number of arguments that applicants could consider in justifying a request for the accelerated procedure. A request could include the following points:
- Information that suggests that the candidate medicinal product could potentially reconcile unmet medical needs. Epidemiological data could supplement this argument, as well as supporting evidence from published literature or registry studies;
- A description of the extent to which it is expected that the candidate medicinal product could fulfil a specific medical need;
- Evidence which justifies the accelerated procedure from a public health perspective. Where comprehensive clinical data is not available an applicant could submit a brief outline of the primary evidence that is available.
The draft revised Guideline stresses the importance of early interaction with the EMA. Applicants are recommended to engage with a Procedure Manager in the EMA prior to the submission of an accelerated procedure request for a candidate medicinal product. It is recommended that a notification of the intention to submit a request be submitted six to seven months before the actual submission of the marketing authorisation application. The draft revised Guideline also advises applicants to request a pre-submission meeting with the Rapporteurs and the EMA product team at the earliest available opportunity. The applicant must provide the following documentation to accompany an application for authorisation in accordance with the accelerated procedure; (i) the Rapporteur’s briefing note to the CHMP concerning the recommendations on the grant of the accelerated procedure; and (ii) the conclusions reached by the CHMP at the end of the meeting during which the request for the grant of the accelerated procedure is discussed. This information must be submitted two to three months prior to the submission of the actual marketing authorisation application.
It is recommended that the justification for the use of the accelerated procedure consist of between five and 10 pages.
The draft revised Guideline emphasises that the timeframe for the handling of the accelerated assessment procedure must be respected by applicants. It is noted that a delay could affect the assessment of the request by the CHMP and Pharmacovigilance and Risk Assessment Committee (“PRAC”). In cases where a request is submitted for an advanced therapy medicinal product, the timetable will be modified to incorporate an assessment by the Committee for Advanced Therapies. It is also noted that a potential start date for the initiation of an accelerated procedure assessment will not commence in December.
Once the draft revised Guideline is implemented in its final form, it will replace the 2007 Guideline on the procedure for Accelerated Assessment pursuant to Article 14(9) of Regulation (EC) No 726/2004.
The consultation process will remain open until 30 September 2015. Comments may be submitted by interested companies and individuals using the template form indicated on the draft revised Guideline to email@example.com.