Overview
On May 4, 2020, The European Medicines Agency (EMA) details the rapid approval procedures for COVID-19 products which includes
- Scientific advice
- Rolling reviews
- Accelerated assessments.
Scientific Reviews:
The European Medicines Agency support R&D to help companies at research and development phase, says, it will reduce the time it takes for scientific review from 40-70 days to 20 days or less, depending on the nature of the request. Moreover, the agency also mentions, not every request will qualify for rapid advice but will still provide scientific advice within the standard timeframes.
EMA typically charges €43,000 to €87,000 for scientific advice to small and medium sized companies, but EMA states it will waive full fees for the companies developing drugs or vaccines for COVID-19.
EMA also states, it will cut down the time of review for Pediatric Investigation Plan (PIP) from 120-20 days to 4 days.
Rollwing Reviews and Accelerated Assessments:
For the review of COVID-19 treatments, the EMA will use two expedited procedures: rolling reviews and accelerated approvals.
Rolling reviews are conducted during public health emergencies and consist of multiple 2-week review cycles to allow assessment of a product as data becomes available.
In case the company do not wish to use rolling review or it does not get accepted for a rolling review, it can apply for accelerated assessment where the review time will be reduced from 210 days to 150 days. The EMA also says, companies can apply for Priority Medicine (PRIME), but which will be suitable for early stages of development of a drug or vaccine.
Moreover, in the EU, decisions related to compassionate use or expanded access is made by the member state level authorities. However, the EMA says, it can provide recommendations on compassionate use for groups of patients eligible for a centralized procedure at a request of a national competent authorities.
Compassionate Use:
In the EU, decisions related to compassionate use or expanded access is made by the member state level authorities. However, the EMA says, it can provide recommendations on compassionate use for groups of patients eligible for a centralized procedure at a request of a national competent authorities. Developers of products for treatment or prevention of COVID-19 are encouraged to contact EMA via email and in this context provide also information on compassionate use applications underway at national level. National Competent Authorities should inform EMA if they are making a product available to a group of patients for compassionate use. A CHMP opinion on a compassionate use can only be initiated by the CHMP based on request from a National Competent Authority.
Regulatory Summary:
Applications for a marketing authorization for products intended for prevention or treatment of COVID-19 will be treated in an expedited manner. The applicants are advised to contact EMA via email to 2019-ncov@ema.europa.eu early in the development to discuss scientific and regulatory aspects of their planned application Should the applicant not wish to use rolling review or in case the application has not been accepted for such review, the applicant may still apply for accelerated assessment.
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More Resources:
- EMA. EMA initiatives for acceleration of development support and evaluation procedures for COVID-19 treatments and vaccines.
- EMA. How EMA fast-tracks development support approval of medicines and vaccines.
FDA Emergency Use Authorization (EUA) for Face Masks Intended for a Medical Purpose, Surgical Face Masks and N95 Respirators