EMA details rapid procedures for COVID-19 products

The European Medicines Agency (EMA) on Monday laid out its tools for expediting the development and approval of medicinal products for coronavirus disease (COVID-19), including faster scientific advice, rolling reviews and accelerated assessments.
 
“Supporting the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines as soon as possible is one of EMA’s top priorities in the COVID-19 public health emergency,” said EMA Director Guido Rasi, stressing that “rapid approval of therapeutics and vaccines will only be possible if applications are supported by robust and sound scientific evidence.”
 
The rundown of its arsenal of rapid procedures comes just days after the agency began a rolling review of Gilead Sciences’ remdesivir and the US Food and Drug Administration (FDA) authorized the drug for emergency use. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus 1 May 2020; FDA authorizes Gilead’s remdesivir for emergency use, Regulatory Focus 1 May 2020).
 
R&D support
 
To help companies at the research and development phase, EMA says it will reduce the time it takes to offer scientific advice from 40-70 days down to just 20 days or less, “depending on the nature of the request.”
 
EMA says that not every request will qualify for rapid advice and that it will still provide scientific advice within the standard timeframes for other requests. The agency previously announced it would fully waive fees for scientific advice to companies developing drugs or vaccines for COVID-19 (RELATED: EMA offers free scientific advice for COVID-19 developers, Regulatory Focus 13 March 2020).
 
“Since assessment standards will need to be maintained, the level of expedition in providing the scientific advice will depend on the number and complexity of the requests and on the availability of resources in the public health threat situation of COVID-19,” EMA explains.
 
EMA also says it will cut how long it takes to review pediatric investigation plans (PIPs) from up to 120 days to 20 days and that it will take just 4 days to run PIP compliance checks before marketing authorizations can be submitted.
 
Review and approval
 
EMA says it will use one of two expedited procedures to review products intended to treat or prevent COVID-19: rolling review and accelerated assessment.
 
EMA explains that during public health emergencies it can conduct rolling reviews, which consist of multiple two-week review cycles to allow for the assessment of a product as data become available.
 
“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,” EMA writes, noting that its accelerated assessments reduce the maximum review time for an application from 210 days to 150 days.
 
EMA also explains that companies can apply for its priority medicines (PRIME) scheme, but says the scheme “is predominantly suitable for treatments and vaccines in earlier stages of development” and notes that it does not expect applications for orphan designation for COVID-19 products.
 
Compassionate use
 
In the EU, decisions related to the compassionate use of medicinal products are made at the member state level, and companies are not able to apply directly to EMA for opinions on compassionate use.
 
However, EMA says it can provide recommendations on compassionate use programs for groups of patients for medicines eligible for its centralized procedure at the request of a national competent authority, as it recently did for remdesivir. (RELATED: EMA advises on compassionate use programs for remdesivir, Regulatory Focus 3 April 2020).
 
EMA says that companies and national competent authorities should notify the agency about any compassionate use programs going on at the national level.
 
EMA