Today we’re looking at how regulatory authorities around the world are responding to the COVID-19 pandemic and, specifically, what flexibility they are offering to support the pharmaceutical industry.
Many aspects of our lives have been affected by the pandemic which has seen cases and deaths around the world.
The pharmaceutical industry has by no means escaped this impact. We have experienced an increase in demand for products used to treat COVID-19 symptoms; the disruption of product supply; an impact on manufacturing, clinical trials and R&D, the curtailment of on-site inspections, problems in meeting timelines and requirements set by regulatory agencies, I could go on…
Let’s have a look at how the regulatory agencies around the world are responding to these issues, starting with the EU.
The EU regulatory authority, the EMA, is prioritising assessments of any COVID-19 related medicines. It is encouraging the use of Day 0 MRP/RUP to get national licences to new member states (particularly those intended to treat COVID-19).
To reduce the risk of shortages or supply problems the EU have implemented an Exceptional Change Management Process (ECMP) for medicines used to treat COVID-related symptoms. The QP can temporarily postpone/ waive testing in the third country and review the product under quarantine in the EU without a CofA – this will be recorded as a deviation and the batch will still be required to be tested before release.
A word on Renewals: The EU has offered certain discretions (to be agreed between MAH and EMA/ national agency) on Renewal applications whereby submissions can be made without the full set of documentation usually required which can then be sent in at a later date.
Regarding GMP/ GDP certificates and Manufacturer/ Import authorisations: the EU has extended expiry of these until the end of 2021, provided no major changes have been made to the site, for example new buildings being added or manufacture of new medicines started. For new sites in the EEA, which have not previously been inspected, these will be assessed remotely.
Regarding batch certification: It’s now possible to perform remote batch certification provided that the QP has access to all the relevant information.
Labels & Leaflets: Provided agreement with the relevant agency in advance, it is now acceptable for national-specific information not to appear on labels and leaflets.
The EP and BP have collaborated to make pharmacopoeial information available for free for a limited period, these include monographs, general chapters, appendices and supplementary chapters).
A COVID-EMA Pandemic Task Force (COVID-ETF) has been established to ensure a rapid and coordinated response to the pandemic. Its aim is to help EU Member States and the European Commission to take quick and coordinated regulatory action on the development, authorisation and safety monitoring of treatments and vaccines intended for the treatment and prevention of COVID-19.
The Medical Devices Regulation (MDR):
On 23 April 2020, the European Parliament and the Council of the EU adopted a proposal to extend the transitional period of the Medical Devices Regulation by one year – until 26 May 2021.