[Stability Testing related News – vol.48]

◆ Covid-19: Handling of Marketing Authorisations (16-Jul-20 ECA)

The processes and procedures relating to marketing authorisations are still strongly influenced by the corona pandemic. On the website of the HMA (Heads of Medicines Agencies) this has been reiterated and the available templates and information to facilitate and manage marketing authorisations and registration procedures have been consolidated and listed.

In addition to the continuously updated catalogue”QUESTIONS AND ANSWERS ON REGULATORY EXPECTATIONS FOR MEDICINAL PRODUCTS FOR HUMAN USE DURING THE COVID-19 PANDEMIC”, the “Template for submission of an application for a Covid-19 exeptional change management process (ECMP)” and the “Template for Step 3 Notification of implementation” are available here.

The overview of the information provided and application templates can be found on the website of the HMA (Heads of Medicines Agencies) in the section CMDh.

◆ Regulatory Authorities worldwide work more closely together because of COVID-19 (21-Jul-20 ECA)

The Swiss authority Swissmedic announced on its website that regulatory authorities around the world will work more closely together due to Covid-19. Three areas have been identified for this: research during pregnancy, medicinal products from clinical trials and monitoring of vaccines in terms of safety and efficacy.

For the second time, representatives from more than 25 countries, representing 28 drug regulatory authorities and the WHO, came together. Observational research is to be intensified by exchanging information on experiences from the development of treatments and vaccines against COVID-19. Data from observations or from clinical practice in the real world are an important complement to the information obtained from clinical trials. The current workshop identified three areas where cooperation between health authorities should be improved:

Pregnancy research on the impact of COVID-19 as well as medicines on pregnant women and their unborn babies
Establishment of clinical cohorts of COVID-19 patients (special observational clinical studies) to share expertise and improve the quality of clinical trial data
Preparation of an infrastructure to monitor the safety and efficacy of vaccines being developed against COVID-19
The improved cooperation should not only help during COVID-19, but also strengthen future observational research by the countries.

Here you can find the report of Swissmedic.

◆ IFPMA Points to Consider for Virtual GMP Inspections – an Industry perspective (23-Jul-20 IFPMA)

The 2020 COVID-19 pandemic has resulted in governments imposing temporary measures such as confinement,
quarantine orders and travel restrictions that are impacting National Regulatory Authorities (NRAs) in their
capacities to perform on-site GMP inspections. Consequently, a number of NRAs have adopted temporary
measures such as performing virtual (or remote inspections) to sustain the supply of high-quality medicines to
patients.

This paper is based on the biopharmaceutical research-based industry’s experience to date of conducting and
receiving remote inspections. It consolidates industry lessons learned from these remote inspections and
proposes shared best practices. It is meant to complement efforts ongoing in other industry organizations such
as EFPIA and PhRMA. These practices can assist in carrying out an efficient and effective remote inspection
and can be developed further as more experience is gained and more data is collected.