The European Union indicated on Monday 20 April that it had updated its regulatory adaptations to COVID-19, in particular with regard to good manufacturing practices (GMP) and safety checks. Regulatory flexibility is among the demands of the pharmaceutical industry, as evidenced by a webinar organised on the same day by the pharmaceutical industry lobby, EFPIA.
Regulatory framework opportunities activated
On 10 April, the Commission, the European Medicines Agency (EMA) and the Directors of the National Medicines Agencies (NMAs) published a question-and-answer paper on the room for manoeuvre available to the pharmaceutical industry to meet the challenges posed by the current crisis.
They have adapted certain provisions of this document, in particular on the conduct of inspections, drug safety monitoring reports and the manufacture and import of medicines in the context of COVID-19. The document provides, for example, for the validity of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) certificates and time-limited wholesale authorisations to be extended until the end of 2021, in some cases using regulatory risk management principles.
The EMA noted that this update focuses on human medicines, while a document on veterinary drugs would be published shortly.
Pharmaceutical industry calls for more regulatory flexibility
The pharmaceutical industry, mobilized to develop treatments and vaccines in response to the pandemic, is demanding greater regulatory flexibility. "The SARS-CoV-2 pandemic requires an innovative and flexible regulatory response, not only to facilitate new diagnostics, treatments and vaccines, but also to sustain the development and delivery of other new products that are in the pipeline", said Alan Morrison, vice president of global regulatory affairs at MSD, during an EFPIA webinar on 20 April.
For example, he called for a shorter decision-making phase from the Commission, continuous data review, simplified safety reports, etc. He also suggested that greater flexibility in labelling could be considered. However, he recognised that safety should not be sacrificed in the interest of expediting procedures. On the issue of vaccine availability, he highlighted a stronger role for the EMA (the ECMA group) that could facilitate a "more collaborative model".
For his part, Paul Stoffel, Chief Scientific Officer of Johnson & Johnson, stressed the need to scale up production capacity now (his company is currently working on a vaccine and is preparing to produce 1 billion units a year) and to have a vaccination strategy to know who to vaccinate first. (Original version in French by Sophie Petitjean)