In general, the overall process of product identification to authorization, may take at least 5-10 years. However, in case of pandemics, public health emergencies, or certain other cases, the overall timeline may need to get shortened. One such action, that supports this, is the rolling review.

A rolling review is a regulatory tool, that the regulatory agency uses, to speed up the assessment of a promising medicine, during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality, and all required documents are submitted at once, at the start of the evaluation in a formal application, for marketing authorization.

However, in the case of a rolling review, the regulatory agency reviews data as they become available from ongoing studies. Once the regulatory agency decides, that sufficient data is available, the company can then submit a formal application. By reviewing the data as they become available, the regulatory agency can come to an opinion on the medicine’s authorization, sooner.

During the rolling review, and throughout the pandemic, the regulatory agency, may be supported by a set of stakeholders, or a task force. This task force brings together experts from across the regulatory network to advise on the development, authorization and safety monitoring of medicines and vaccines, and facilitates quick and coordinated regulatory action.

The key features of rolling review by the European Medicines, are as follows:

Each Rolling Review submission occurs in eCTD format with an application form, a Module 2 overview and responses to a cumulative listing of all outstanding questions from previous review cycles.

There can be several Rolling Review cycles with each cycle normally requiring a two-week review, depending on amount of data. Responses to list of questions from previous Rolling Review cycles are to be incorporated into subsequent Rolling Review submissions.

Please note, that rolling review only expedites the authorization process of medicine, without compromising patient safety. One need not be surprised if this becomes a new normal in the accelerated authorization processes, that will ultimately benefit the pharmaceutical industry as well as the Public Health. However, this may put some load on the workload of the regulatory agencies. Again, collaboration amongst the regulatory agencies may further help!