On 4 May 2020, the European Medicines Agency (EMA) issued a guidance to support development and regulatory approval for treatments and vaccines for COVID-19 with the involvement of the dedicated EMA Pandemic Task Force (COVID-ETF). It sets out the available regulatory pathways to fast-track assessment of both new or repurposed methods of treating or preventing COVID-19.
This guidance is part of EMA's efforts to support the development and availability of medicinal products for COVID-19 to address this public health emergency. See also EMA's guidance on clinical management trials (which we have summarised in a prior Advisory)
This latest guidance is based on the existing and established regulatory procedures to accelerate regulatory review and approval with appropriate adaptations in direct response to COVID-19 pandemic.
Speeding up the pre-submission phase
The following procedural steps have been created to facilitate the product development by aligning with the expected technical requirements to generate the right level of evidence to support regulatory approval.
Rapid scientific advice
Rapid scientific advice is intended to provide the earliest opportunity for manufacturers to engage in early dialogue with the EMA's Scientific Advice Working Party, COVID-ETF, and the Committee for Medicinal Products for Human Use (CHMP).
EMA has not set out any specific requirements for the timing of submission of the request for rapid scientific advice or the content of the related submission to the Agency. There is flexibility for manufacturers to choose the timing for engagement concerning their respective development programmes which may vary considerably according to the product characteristics and the mode of use. EMA intends to provide the rapid scientific advice in as little time as 20 days, as opposed to the "regular" 40 to 70 days procedure duration.
Pre-scientific advice and PRIME
For products in the very early stages of their development plans, not yet suitable for rapid scientific advice, manufacturers may consider early informal guidance from the COVID-ETF in advance of the rapid scientific advice later in their development process. There exists an option for product designation under the Priority Medicines (PRIME) scheme established by the EMA to enhance interaction and early dialogue to optimise product development so that promising medicines can reach patients earlier.
Expedited PIP approval and compliance check
According to the guidance, the procedure for expedited approval of PIPs for medicinal products and vaccines for COVID-19 may be completed within 20 days depending on the complexity of the PIP and the sponsor's preparedness to quickly provide any additional information and answer any questions from the EMA during the procedure. Similarly, PIP compliance check timelines can be reduced to four days if necessary to accelerate grant of the related marketing authorisation.
Speeding up the marketing authorisation procedure
EMA intends to use the following tools to accelerate the marketing authorisation procedure by not restricting the Agency to the standard time-frame for 210-day active assessment :
The use of the rolling review procedure enables the EMA to start the review of the data supporting the application before the formal submission of the application whilst the product development is still ongoing. The appointed Rapporteurs of the CHMP will review the data as soon as they become available. It is envisaged that the regulatory assessment will encompass several rolling review cycles before a final decision on product approvability can be made. Each review cycle will require 2 weeks to complete. The guidance clarifies that the submission for the rolling review must be in eCTD format to include:
- an application form;
- Module 2 containing the overview and summary documents for the application; and
- responses to a cumulative listing of all outstanding questions from previous rolling review cycles.
Accelerated assessment procedure
The Regulation governing the Centralised procedure gives power to the EMA and the CHMP to complete the regulatory review within 150 days so that an opinion on product approval can be adopted expeditiously. Depending upon the quality of the submitted data, the minimum duration of the procedure could be as short as 80 days or even less.
The guidance also addresses the possibility for unauthorised medicinal products to be made available to patients in the EU Member States through compassionate use programs. These programs are implemented by the competent authorities of the EU Member States but the CHMP may, upon request by a competent authority of an EU Member State, provide an opinion on such programs that could facilitate a common approach across the EU Member States.
While pharmaceutical companies have no role in the initiation of the implementation of compassionate use programs, they can help accelerate the process by preparing and having available data to facilitate the CHMP review.
Article originally published on 7 May 2020
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.