EIPG Newsletter

The quality of healthcare in the EU is a central debate going on at the European institutions, in order to identify how to reach a more equal and sustainable situation of the healthcare systems in use by different countries

ISO IDMP standards are at the basis of SPOR systems and are used to unambiguously identify medicinal products and all substances and facilities used for their manufacturing using uniformed definitions. The so obtained master data can be used for multiple regulatory procedures in different geographical areas

Discussions on the SPC manufacturing waiver are ongoing at the European institutions. Lobbying is also occurring to protect the diverging interests of originators and genericists. The ENVI and INTA Committees of the European Parliament published their opinions on the issue

EMA's director general Guido Rasi is among the authors of a paper published in Clinical Pharmacology and Therapeutics, discussing from a regulatory perspective the use of real world data to boost pharmaceutical development

EIPG is planning the launch of an Advisory Group for the education of industrial pharmacists, in order to better support competences needed by the industry. Representatives of the association participated to the EMA meeting on shortages of medicines. EIPG is also collecting opinions on ICH Q12 draft guideline to be submitted to the open consultation. A webinar on data integrity is also planned for 11th December

Legislative tools to regulate the AI-based sharing of healthcare data and personal information are still missing. Many new initiatives are ongoing to create new IT infrastructures able to acquire personal data while leaving control to individuals that conferred them, and possibly compensating the possibility to use data for research purposes. A survey by KPMG shows that UK's citizens would be more prone to confer data to the National Health Services than to other organisations.

Many uncertainties are expected in the filed of clinical trials, while the date of the Brexit is approaching. The European Commission released a Notice to stakeholders to provide guidance to companies. A Q&A document is also available discussing the sourcing from the UK of innovator pharmaceutical products to be used in bioequivalence studies of generics outside UK. Finally, UK's MHRA has launched a public consultation on how to adapt the country's regulatory framework in the case of a "no deal" exit.

The advent of many innovative AI-based technologies is dramatically changing the reference framework of the methodologies used for the screening of new drugs. A review signed by industrial experts summarises the current reference framework. New business models are also emerging to boost AI-based pharmaceutical innovation

The new health technology assessment (HTA) regulation has been approved in first reading by the European Parliament, after the final opinions of relevant Committees have been issued. The next phase towards final approval will see the negotiations between the Parliament and the European Commission

EIPG's representatives attended the Industry Stakeholder meeting on Brexit and operation of centralised procedure of the 24th September 2018, organised by the European Medicines Agency (EMA). Updates also on the work programme for the Task Force of the Heads of Medicines Agencies (HMA) and EMA, published in August, and on incoming EIPG's webinars.