CMDh explains impact of COVID-19 on mutual recognition, decentralised procedures

The Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) last week explained how regulatory flexibilities for medicines amid the coronavirus disease (COVID-19) pandemic apply to products reviewed or authorized under mutual recognition and decentralised procedures.
 
The guidance comes after the European Commission, European Medicines Agency (EMA) and Heads of Medicines Agencies explained their regulatory expectations for medicinal products during the pandemic. (RELATED: EMA Q&A explains regulatory expectations for drugs during the pandemic, Regulatory Focus 10 April 2020; EMA updates on regulatory expectations amid COVID-19, Regulatory Focus 20 April 2020).
 
Guidance
 
In a seven-page guidance, CMDh lays out a set of 13 questions and answers explaining the potential impact of COVID-19 on mutual recognition and decentralised procedures and how certain flexibilities apply to products subject to the procedures.
 
“Many pharmaceutical companies are being directly and indirectly affected by this global situation and had to modify their working procedures and/or regulatory activities to respond to the demands,” CMDh writes, noting that regulators are also working under similar circumstances.
 
While CMDh says marketing authorization holders (MAHs) should endeavor to submit renewal applications by the legal deadlines, it says that companies impacted by COVID-19 may submit just the renewal application form and cover letter to the reference member state (RMS) and concerned member state(s) (CMS), noting in the cover letter that the full dossier is delayed due to the pandemic. Complete dossiers should be submitted “as soon as possible but at the latest within six months,” CMDh writes.
 
Because products related to COVID-19 are being prioritized, CMDh says that some marketing authorization application or post-authorization procedures may be delayed or frozen if it is in the interest of the applicant or RMS/CMSs.
 
“It is exceptionally agreed for [decentralised, mutual recognition and repeat use procedures], renewal and type II variation procedures to allow a ‘freezing’ … or ‘rolling back’ … of the procedure timetable due to unexpected and COVID-19 related capacity issues within the RMS, or when it is not possible for applicants to submit responses due to the COVID-19 pandemic,” CMDh writes.
 
In such cases, CMDh says the applicant or MAH and RMS “should closely communicate” on what steps to take.
 
CMDh also explains that the exceptional change management process (ECMP) outlined in the EMA and Commission’s guidance is only applicable to address shortages of products used to treat COVID-19 and further explains how to make use of the process.
 
CMDh clarifies that the ECMP cannot be used to implement new manufacturers for active substances or finished products when the active substance or finished product specifications would need to be amended.
 
The guidance also addresses issues related to variation procedures for products used to treat COVID-19, qualified person statements and declarations and the importation of products used to treat COVID-19 at the national level.
 
CMDh, Guidance