How CMDh helps Marketing Authorisation Holders (MAHs) to facilitate regulatory procedures during the COVID-19 crisis?

The SARS-CoV-2 virus pandemic has undoubtedly affected various areas of our lives, not only our private lives and interpersonal contacts, but it has also firmly affected the areas of lives directly related to work and career. Even pharmaceutical industry directly connected with medicinal products production and responsible for medicinal products marketing was strongly affected by COVID-19 pandemic situation.

From the regulatory point of view, the crisis caused by the COVID-19 pandemic has led to many problems related to registration procedures of medicinal products, post-registration variations proceeding and renewal procedures. This article, based on ,,Practical guidance of the CMDh for facilitating the handling of processes during the COVID-19 crisis” (May 2020; CMDh/418/2020, Rev.1), will briefly discuss new regulatory opportunities directly related to regulatory affairs issues, enabled,  by Co-ordination Group for Mutual Recognition (MRP) and Decentralised (DCP) procedures - Human (CMDh) response to mitigate the effects of the current pandemic.

Timelines for the assessment of ongoing applications

Importantly at the beginning, according to the CMDh guideline, all registration procedures for medicinal products, which are directly connected with COVID-19 treatment, or which are considered as critical due to the COVID-19 pandemic, will be prioritized and expedited.

Furthermore, in certain cases, start or restart of procedure for medicinal products registered in European procedures may be delayed. Application for procedure delay may be submitted by the Applicant, but also by RMS or CMS if this is in the interest of the Applicant.

What is more, CMDh enabled two more possibilities of timeline delay for DCP/MRP/RUP, renewal and post-registration type II variation procedures – “freezing” and “rolling back”.

“Freezing” shall be understood as the timetable holding at the same procedure Day as it is, and then restarting it as soon as the responses will be received, or as soon as the RMS Assessment Report will be finalized. Such solution may be crucial in case of absence of some documents required for the registration procedure of the medicinal product, for example lack of GMP certificate – due to the pandemic, GMP Inspection may be hindered, which will result in the impossibility of GMP certificate issuance.

Of course, due to the restrictions caused by COVID-19, period of validity of the GMP certificates was automatically extended until the end of 2021. However, the above-mentioned problem still exists and affects the manufacturers who have never been audited and therefore do not have a GMP certificate, the validity of which could be extended.

 “Freezing” is envisaged to be used shortly before the end of a procedure, therefore in the final phase of registration procedure.

“Rolling back” shall be understood as bringing the procedure back to the validation phase or bringing back the procedure to clock stop period, with the usual timeframe of handling responses in the clock stop. Such solution is envisaged to be used immediately after the procedure start or procedure restart and before Day 120 of the registration procedure.

Both: “freezing” and “rolling back” of the procedure timetables may be applied due to the unexpected and COVID-19-related capacity issues within the RMS. Moreover, when it is not possible for Applicants to submit responses due to the COVID-19 pandemic, above-mentioned solutions shall be also applied. What is important, the Applicant is obliged to inform the RMS with preserved time period of a necessary interruption of the procedure. Furthermore, the reason of not submitting the responses to the competent Authority shall be duly justified and justification must be related to the COVID-19 pandemic.

The Applicant and RMS should stay in constant contact, closely communicate and discuss registration strategy for specific medicinal product and together decide the most suitable solution.