EIPG Newsletter

Post-Brexit era

The post-Brexit era started on 1 January 2021, when the United Kingdom became a third country. Special provisions have been put in place for Northern Ireland. EMA issued guidance for the pharmaceutical industry on how to deal the necessary changes. The UK's regulatory agency MHRA also released its new guidances and launched the new IPAL programme for the development of innovative medicines

EMA and HMA’s new joint regulatory strategy

EMA and HMA’s new joint regulatory strategy to 2025 will inspire the actions of the EMRN network of European regulators. The document discusses how to approach many open issues to speed development and access, from the governance of complex, international supply chains to the full implementation of AI for real data acquisition and analysis

Trends in APIs development for 2021

The new mRNA vaccines are just a first example of the growing importance of medicinal products developed using gene and cell-based technologies. Highly potent APIs require the integration of complex manufacturing chains and pose challenges also as for the formulation of the drug products. Artificial intelligence, automation and new, engineered bacterial strains are at the basis of a new life for fermentation manufacturing

EIPG: Upcoming Webinar on MDR, New Education and Training Standards for UK and EMA...

The next EIPG webinar will be held in conjunction with PIER and University College Cork on Wednesday 3rd February 2021 on The Practical Implementation of EU Regulations for Medical Devices and in vitro Diagnostic Medical Devices. The European Medicines Agency (EMA) issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion. The General Pharmaceutical Council (GPhC) has approved new standards for the initial education and training (IET) of pharmacists.

Time for change: The digital transformation of the Pharmaceutical Industry

A survey run by The Reuters and Omnipresence analysed how the Covid-19 emergency favoured the smoothly digital transformation of the pharmaceutical industry. Remote working is becoming the new normal also to run marketing activities and clinical studies, but there is still need to build robust digital infrastructures to fully operate the new model

EIPG: 2019 was about Brexit, 2020 was about Covid-19. What will 2021 be about?

Covid-19 has changed the way we live, and work and the entire world is witnessing its resurgence after the first wave. A look back on the year in a reflection message by the Vice-president Communications of EIPG. EIPG Vice-President European Affairs Mr. Maurizio Battistini was invited to participate in a webinar entitled “Diversification of the medicines supply chain” in the context of medicine shortages, co-organised by GIRP, EAHP, and PGEU. Follow EMA’s social media campaign on COVID-19 vaccines

Hungary: Logistic challenges in the pharma industry due to Covid-19

The Covid-19 pandemic resulted in many disruptions of the pharmaceutical supply chains, both at the international and EU cross-borders levels. The implementation of new models to handle logistics in this essential sector may represent an opportunity for the future

The new European Education Area

Six key principles inspire the EU Commission's new Communication establishing the European Education Area, the reference framework that will reshape educational activities in coming years

Regulatory sandboxes to experiment real-world innovation

Regulatory sandboxes and experimentation clauses are the tools the EU Commission may implement to favour the real-world testing - limited in time and scope - of new technologies and services

The EU Commission published the new Pharmaceutical Strategy

The new EU Pharmaceutical Strategy will inspire all the future actions the Commission is planning to sustain and expand this key sector of the European economy, and it will act in conjunction to other pieces of new legislation