Frits Stulp of Iperion Life Sciences Consultancy assesses the impact of the Covid-19 crisis on European progress towards Identification of Medicinal Products (IDMP) data standardisation. At a time of global focus on getting drug and vaccines to market quickly and safely, 2021 looks set to be the year when the potential of IDMP is realised.
Standards
Covid-19 has dominated the headlines in life sciences in 2020. But it would be wrong to conclude that everything else has been shelved while focus and resources have been diverted to responding to the pandemic. In fact, Covid-19 has shone a light onto the broader potential for global data standards, including those defined via ISO IDMP (Identification of Medicinal Products) which Europe is now so close to implementing via the EMA SPOR programme.
Amid the disruption caused to just about everything over the last year, this has also been a time of great emphasis on healthcare and the role of the pharma organisations, marketing authorisation applicants and holders (MAAs and MAHs), and of regulators, in a crisis. Speed to market (bringing relevant medicinal products, for example new vaccines, to market swiftly), yet also thoroughness in safety and quality assessments, have become paramount and visible to a much greater degree in society. Countries, governments, health care providers, entire societies are crying out for approved medicinal products, but no one can afford for standards and requirements to be compromised in the rush to deliver what’s needed. No one wants a vaccine with side-effects worse than the symptoms of Covid. So stakeholders across industry and the regulatory community have had to perform a careful balancing act.